Digital Health & Technology
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January 14, 2025
HHS' Strategic Plan For Healthcare AI: 3 Things To Know
A federal strategic plan for the use of artificial intelligence in healthcare calls for setting clear regulations and collaborating with private groups as part of a broad framework to support innovation and protect patients.
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January 14, 2025
How Calif. Became 1st State To Ban AI Healthcare Denials
Amid growing concerns about healthcare insurance claims and artificial intelligence, a first-of-its-kind California law requires a qualified human healthcare provider – not algorithms – make critical calls based on medical necessity. Similar legislation is anticipated in other states.
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January 13, 2025
California's AG Warns Businesses State Is Not AI 'Wild West'
California Attorney General Rob Bonta warned businesses on Monday that the state is not the "wild west" of artificial intelligence and has various laws on the books preventing the technology from being used to discriminate or violate people's rights.Â
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January 13, 2025
Nvidia's Healthcare Ambitions Grow In New Partnerships
Nvidia announced Monday that it has inked four new healthcare partnerships, a move that comes on the first day of the annual J.P. Morgan Healthcare Conference in San Francisco.
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January 10, 2025
Masimo, Apple Fight Over Watch IP In Post-Bench Trial Briefs
Masimo and Apple have submitted dueling briefs to a California federal judge following a trade secret retrial over health sensing technology in Apple's smartwatches, with Masimo maintaining Apple poached its employees to steal its intellectual property and Apple contending Masimo failed for years to "back up their spurious claims" of misappropriation.
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January 10, 2025
Infosys Files Antitrust Counterclaims In Trade Secrets Suit
Healthcare payments software company Infosys has hit back with antitrust counterclaims against Cognizant TriZetto Software Group's Texas federal court suit accusing Infosys of abusing its system access to develop competing services.
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January 10, 2025
Tech Co., Feds Seek Wins In Commercial Item Preference Row
A tech company is asking a federal judge to block the Centers for Medicare and Medicaid Services from proceeding with solicitations that stand to replace so-called batCAVE and Signal software it developed that is already providing the desired functionality.
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January 10, 2025
9th Circ. Affirms Hearing Aid Co.'s Win Over Investor Suit
The Ninth Circuit on Friday handed a win to Eargo Inc. and affirmed the dismissal of a securities class action against the hearing aid company, which alleged that the company and its top brass acted with intent to commit insurance billing fraud.
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January 10, 2025
Social Media Apps Fail To Trim Calif. Mental Health Mass Tort
Meta Platforms, YouTube, Snap and TikTok have lost a bid to cut failure-to-warn claims from consolidated litigation over their social media platforms' alleged harm to youth mental health, with a California state judge ruling that neither the Communications Decency Act nor the First Amendment bar liability based on an app's own features.
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January 10, 2025
1st Circ. Questions Reach Of Anti-Torture Âé¶¹´«Ã½ In Civil Cases
The First Circuit on Friday hinted it may be considering limits on the jurisdiction of the Torture Victims Protection Act, during a hearing where former Justice Stephen Breyer recalled concerns he first raised on the Supreme Court that an overly broad reading could pave the way for other nations to arrest Americans for incidents on U.S. soil.
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January 09, 2025
'Stunned': Judge Rips Atty For Violating Antitrust Trial Order
A California federal judge overseeing an antitrust jury trial over claims that Intuitive Surgical was a monopolist that abused its power by blocking hospitals from using a service to extend the life of a component related to its surgical-robot arms said Thursday she was "stunned" when plaintiff Surgical Instrument Service showed a video that violated a pretrial order.
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January 09, 2025
Cancer Org Fails To Get Rival's TM Counterclaims Tossed
A Georgia federal judge said Thursday that the Glioblastoma Foundation Inc. can't yet escape a series of counterclaims filed against it by a rival nonprofit amid a trademark spat, ruling that its defenses in a dismissal bid largely relied on factual issues about whether the rival fraudulently obtained the marks at issue.
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January 09, 2025
VITAS Must Face Wiretap Suit Over Customer Service Calls
A California federal judge declined to toss a putative class action alleging VITAS Healthcare violated wiretapping laws by helping a third-party software developer eavesdrop on calls with VITAS' customers, noting Wednesday the third party was capable of using the data derived from the calls for its own purposes.
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January 08, 2025
Intuitive Killed Biz For Reusing Robo-Surgery Arms, Jury Told
The president of a family-owned medical instrument repair business suing biotechnology company Intuitive Surgical on antitrust claims told a California federal jury Wednesday that his company saw a "huge opportunity" in providing a service that extended the life of Intuitive's surgical robot arms, but hospitals balked after Intuitive sent threatening letters.
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January 08, 2025
Patent Board Knocks Out Most Of Apple Patent
Two rulings out of the Patent Trial and Appeal Board have wiped out several claims in a patent Apple is asserting against a medical software company that was initially first to assert patents against Apple over health-related programming in the Apple Watch.
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January 08, 2025
Telligen's TM Suit Against IT Co. Can Move Forward
A California federal judge is letting a trademark lawsuit from health data company Telligen proceed against information technology company Telligens, ruling that he was not yet convinced that the suit was filed 10 years too late.
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January 08, 2025
Biotech Co.'s Facility Failures Lost Investors Money, Suit Says
The executives and directors of biotechnology company Humacyte Inc. have been hit with a shareholder derivative suit in North Carolina federal court alleging the company concealed that its manufacturing facility failed to comply with certain quality assurance practices, leading to delayed regulatory review for its product candidate.
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January 07, 2025
Robo Surgery Co. Gets Billions From Selling Parts, Jury Told
Surgical Instrument Service accused Intuitive Surgical at the start of a federal trial Tuesday of being a monopolist making billions of dollars by blocking hospitals from extending the life of reusable surgical-robot components, while Intuitive blasted the medical instrument repair company for "trying to misuse antitrust laws to enrich itself."
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January 07, 2025
HHS Fines Mass. Health Firm $80K Over Ransomware Attack
Elgon Information Systems, which provides digital medical record and billing support services, will pay $80,000 over alleged healthcare data protection rule violations following a ransomware attack on its systems in March 2023 that impacted roughly 31,248 customers, the U.S. Department of Health and Human Services announced Tuesday.
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January 07, 2025
HIPAA Cyber Rule Shake-Up Arrives On Eve Of Trump's Return
A massive cybersecurity rule change proposed this week would require healthcare providers and insurers to protect patient data with multifactor authentication and other safeguards. Attorneys are watching to see if the Trump administration changes course.
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January 06, 2025
Labcorp Loses Appeal Of Gene-Testing Patent In $372M Case
Labcorp, one of the world's largest chains of clinical lab providers, lost its appeal over a patent tied to a $372 million judgment it is facing in the Western District of Texas, after Federal Circuit judges on Monday upheld an administrative patent board ruling against it two years ago.
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December 20, 2024
Medical Records Co. Wants Rival's Antitrust Suit Tossed
Epic Systems Corp. told a New York federal court that an antitrust case lodged by Particle Health Inc. is really just payback for revealing concerns that Particle allowed its customers to inappropriately access personal medical records.
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December 20, 2024
Top Privacy & Cybersecurity Developments Of 2024
The state data privacy law patchwork continued to add new and varied pieces in 2024, while major hacks shook up the healthcare industry and other critical sectors, and the first U.S. laws setting guardrails for the use of artificial intelligence technologies emerged.
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December 19, 2024
Google Health Tracking Plaintiffs Fight To Keep Suit Alive
A California federal judge who was asked by Google to toss a proposed class action alleging that the tech giant illicitly scoops up users' personal data from healthcare providers' websites indicated during a Thursday hearing that he might grant the request while adding that he still has "a lot more thinking to do."
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December 17, 2024
UNC Doctor Can't Shield Minor Transgender Patients' Records
A University of North Carolina doctor cannot assert privilege over medical records sought from the university by state Republicans fighting a suit by the physician and others seeking to enjoin a law imposing limits on transgender care for minors, a federal magistrate judge has ruled.
Expert Analysis
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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.
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Potential Defendant Strategies Amid Calif. Privacy Questions
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.
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Health Policy Legislative Landscape May Remain Frozen
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.
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What Businesses Should Know About NJ Privacy Bill
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.
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Staying Ahead Of The AI Policymaking Curve
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.
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The 7th Circ.'s Top 10 Civil Opinions Of 2023
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2023, and explain how they may affect issues related to antitrust, constitutional law, federal jurisdiction and more.
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DOJ's Biopharma Settlement Raises Anti-Kickback Questions
In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Âé¶¹´«Ã½.
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Uncharted Waters Ahead For FCA Litigation In 2024
Following a year of significant court decisions, settlements, recoveries and proposed amendments, 2024 promises to be a lively year for False Claims Act actions and litigation, and one that will hopefully provide more clarity as FCA jurisprudence evolves, say attorneys at Crowell & Moring.
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Healthcare Industry Must Prepare For Greater AI Regulation
Healthcare entities that use even basic machine-based systems should pay close attention to a recent executive order and a proposed bill, both of which focus on artificial intelligence safety and security, and signal the government's intent to establish a regulatory framework for AI-enabled technology, says Kristen Petry at Spencer Fane.
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What To Know About FCA Cybersecurity Enforcement
Now is a good time for practitioners, government contractors and potential relators to review recent developments in cybersecurity-related False Claims Act enforcement, and consider best practices for navigating this space in the new year, say Ellen London at London & Stout, and Li Yu and Molly Knobler at DiCello Levitt.
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Digging Into The Debate On FDA's Proposed Lab Test Rule
A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.
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AI Executive Order's Life Science, Healthcare Industry Effects
The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.
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5 Most Notable Class Action Standing Cases Of 2023
Key appellate class action decisions this past year continued the trend of a more demanding approach to the threshold issue of standing during each phase of litigation, say attorneys at MoFo.