Digital Health & Technology
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October 03, 2024
Dental Laser Co. Can Tap $5M DIP For Swift Ch. 11 Sale Plans
Biolase Inc., which makes laser systems used by dentists, received a Delaware bankruptcy judge's approval Thursday to access $1.4 million of an up to $5 million debtor-in-possession package as it plans for a quick sale in Chapter 11.
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October 02, 2024
Colo. Judge Sees No Injuries In Health Data Breach Class Suit
A Colorado federal judge has dismissed a proposed class action alleging a software company waited nearly three months to tell data breach victims about hackers accessing personal and medical information for more than 250,000 people, concluding the plaintiffs' allegations weren't enough to give them standing.
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October 02, 2024
Dental Laser Maker Biolase Hits Ch. 11 With $33M In Debt
Biolase, a manufacturer of lasers used in dental procedures, is seeking bankruptcy protection in Delaware, and has disclosed roughly $33 million in debt and a $14 million stalking horse offer for its assets, citing financial challenges that it said stemmed from slow market adoption of new technology and economic headwinds.
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October 02, 2024
ExecuPharm Agrees To Pay Ransomware Victims $10K Each
U.S. pharmaceutical giant ExecuPharm will pay victims of a data breach up to $10,000 in reimbursements, compensation for lost time, three years of credit monitoring, and $675,000 in attorney fees after a Pennsylvania federal judge gave his final approval to a class action settlement.
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October 01, 2024
Jefferson Health Can't Ditch Suit Over Meta Data Sharing
A Pennsylvania federal judge has refused to toss a proposed class action accusing Jefferson Health of unlawfully sharing patients' confidential health information with Meta Platforms Inc., finding that the plaintiffs had cured prior deficiencies to adequately support their wiretap and privacy claims.
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October 01, 2024
NC Hospital Hit With More Class Claims Over Data Breach
Columbus Regional Healthcare System's legal woes have worsened with more privacy breach claims filed against it by patients whose personal information was exposed by a May 2023 cyberattack on the healthcare provider's network.
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September 27, 2024
9th Circ. Says Stem Cell Treatment Not Exempt From FDA Rule
Two California clinics' experimental stem cell treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations, the Ninth Circuit ruled Friday, reviving the federal government's bid to stop the clinic from marketing the products as cures for certain diseases without U.S. Food and Drug Administration review.
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September 26, 2024
HHS Flags Ransomware Rise In New Deal With Wash. Provider
A Washington state-based healthcare provider has agreed to pay $250,000 and boost its data security to resolve the U.S. Department of Health and Human Service's enforcement action over a 2017 ransomware attack, amid what the agency said has been a steep rise in reports of such cyberattacks over the past six years.
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September 26, 2024
Senate Bill Calls For Stronger Healthcare Cyber Standards
Democratic lawmakers introduced legislation Thursday aiming to better protect patient health information and avoid cyberattacks by strengthening cybersecurity standards, months after a highly publicized data breach earlier this year of a UnitedHealth unit that lacked basic security measures like two-factor authentication.
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September 25, 2024
UpHealth Wins Most Of $115M Award In Glocal Merger Dispute
Bankrupt digital health services company UpHealth can enforce a large part of a $115 million arbitral award against the Indian healthcare services platform Glocal in their feud over an ill-fated merger, an Illinois federal judge has ruled.
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September 25, 2024
Buffalo-Based Cyber Law Pro Joins Pierson Ferdinand
Fast-growing virtual law firm Pierson Ferdinand LLP announced that an experienced cybersecurity attorney with a focus on the healthcare industry joined as a partner based in Buffalo, New York.
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September 24, 2024
Google Can't Ditch Privacy Suit Over Period App Data Sharing
A California federal judge has refused to release Google from a proposed class action alleging the company used a data analytics tool to wrongfully retrieve data from menstruation tracking app Flo, rejecting the tech giant's arguments that the plaintiffs lacked standing and had consented to the disclosures.
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September 24, 2024
Philips Must Face Investor Suit Over FDA Compliance Issues
Health technology company Koninklijke Philips and its former CEO cannot escape a suit accusing them of misleading investors about the safety and compliance of its subsidiary's sleep and respiratory care products, which were recalled in 2021, but its chief financial officer and a former CEO of a Philips subsidiary were allowed to exit the case for good.
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September 24, 2024
2nd Circ. Partly Revives Suit Over $18.5B Telehealth Deal
The Second Circuit on Tuesday partially revived a suit against telehealth company Teladoc Health Inc. brought by investors who claim they were misled about the status of its integration with Livongo following their $18.5 billion merger.
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September 23, 2024
Medical Records Co. Accused Of Blocking Data Access
A company that helps insurance providers access patient data on Monday accused medical records company Epic Systems Corp. of violating antitrust law by using its monopoly over electronic health records to squash an emerging competitor.
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September 20, 2024
Fla. Judge Trims Health Co. Data Breach MDL
The Florida federal judge overseeing the multidistrict litigation of a health benefits administration company impacted by a data breach dismissed several state consumer law claims but said those who brought lawsuits can sue, saying they've plausibly alleged injuries after their personal information was allegedly stolen by a cybercriminal group.
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September 17, 2024
HIMSS Legal Chief Reflects On Balancing AI, Legal Risk
As artificial intelligence finds itself taking up a large role in the healthcare industry, experts say they're watching closely to see how potential regulations are set to shape the industry, especially as the technology is expected to outpace legal frameworks.
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September 13, 2024
The 2024 Regional Powerhouses
The law firms on Law360's list of 2024 Regional Powerhouses reflected the local peculiarities of their states while often representing clients in deals and cases that captured national attention.
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September 13, 2024
23andMe Inks $30M Data Breach Deal With 6.4M Users In MDL
Personal genomics company 23andMe has reached a $30 million settlement to resolve multidistrict class action litigation on behalf of more than 6 million customers whose personal data was stolen and in some cases leaked onto the dark web, according to a California federal court filing Thursday.
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September 11, 2024
Health Co. Owes $65M For Breach Of Medical Data, Nude Pics
Pennsylvania-based healthcare company Lehigh Valley Health Network will pay $65 million to individuals who had their private information, including cancer patients' nude images, exposed in a data breach, the plaintiffs' lawyers announced Wednesday.
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September 10, 2024
Amazon Must Trim 'Halo' TM For EU Market
Amazon Technologies could not convince the EU's intellectual property office to let it register trademarks for "halo" unscathed, with the office backing a Californian health technology company's bid to trim key protections for medical monitoring devices and health assessment services.
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September 10, 2024
Nelson Mullins Adds Baker Donelson Health Pro In Houston
Nelson Mullins Riley & Scarborough LLP has continued expanding a Houston shop that opened months ago by bringing on a healthcare attorney from Baker Donelson Bearman Caldwell & Berkowitz PC whose wide-ranging practice has included representing hospitals and other providers on cybersecurity and related issues.
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September 09, 2024
House OKs Bill To Bar Contracts With Chinese Biotech Cos.
Driven by concerns about U.S. genetic data being shared with the Chinese government, House lawmakers passed a bill on Monday to bar federal agencies from buying certain biotechnology linked to the Chinese government or from contracting with firms that use those products.
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September 06, 2024
Glioblastoma Org. Wants End To Rival's Use Of 'GBM'
The Glioblastoma Foundation has hit a competing nonprofit with a suit alleging that the group's use of the initials "GBM" in its name has ripped off its trademark and sown confusion among donors who can't tell the two organizations apart.
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September 05, 2024
Nvidia, Microsoft Face Patent, Cartel Allegations In Texas Suit
A new lawsuit accuses Nvidia of holding "monopoly power" over the market on graphics processing in the artificial intelligence space and alleges the tech company is colluding with Microsoft and a prominent patent risk management company to squeeze out a small startup that claims to have developed the "fundamental intellectual property" behind that technology.
FDA Offers Road Map For Remote Trials, But Questions Linger
New federal guidance may encourage drug and medical device companies to carry out more of their research in decentralized, remote clinical trials, allowing them to enroll a more diverse set of participants but generating new legal questions.
Healthcare's AI Integration Is In Limbo As Laws Lag Behind
As healthcare organizations look to incorporate artificial intelligence into their systems, they're coming across a unique problem: They're ahead of the rules.
Hospital Web-Tracker Clash Highlights Enforcement Challenge
A closely watched case now heading to the Fifth Circuit could shape federal enforcement efforts targeting the disclosure of private health information and clarify how hospitals may use online tracking technologies.
Expert Analysis
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Defending AI, Machine Learning Patents In Life Sciences
Ten years after the U.S. Supreme Court's decision in Alice v. CLS Bank, artificial intelligence and machine learning technology remain at risk for Alice challenges, but reviewing recent cases can help life sciences companies avoid common pitfalls and successfully defend their patents, say attorneys at Mintz.
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Takeaways From Texas AG's Novel AI Health Settlement
The Texas attorney general's recent action against a health tech company marks another step in rapidly proliferating enforcement against artificial intelligence and privacy issues across multiple states, and highlights important risk mitigation considerations for health companies that implement AI systems, say attorneys at Troutman Pepper.
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Proposed Legislation May Crack Down On Online Drug Ads
A bill recently proposed in Congress could serve as a sea change in how the U.S. Food and Drug Administration regulates drug-related speech, with significant trickle-down effects on various corners of not only the drug industry but also on consumers and providers themselves, say Dominick DiSabatino and Arushi Pandya at Sheppard Mullin.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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What's In Colorado's 1st-Of-Its-Kind Neural Privacy Law
Colorado recently became the first U.S. state to directly regulate neurotechnology with new legislation amending the Colorado Privacy Act to specifically protect biological and neural data, offering an example of how lawmakers can tackle the perceived regulation gaps in this area, say attorneys at Goodwin.
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Assessing Algorithmic Versus Generative AI Pricing Tools
A comparison of traditional algorithmic pricing models and those powered by generative artificial intelligence can help regulators and practitioners weigh the pros and cons of relying on large language models to price products or services, say Maxime Cohen at McGill University, and Tim Spittle and Jimmy Royer at Analysis Group.
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What FCA Cases May Look Like In The Age Of Generative AI
Generative artificial intelligence raises unique considerations both in the context of potentially leading to False Claims Act cases and in the discovery and litigation phases of these lawsuits, says attorney Rachel Rose.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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The Road Ahead For Regulation Of Digital Twins In Healthcare
Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.
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After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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What's New In The AI Healthcare Regulatory Space
Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.
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3 Policyholder Tips After Calif. Ruling Denying D&O Coverage
A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.