Digital Health & Technology
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March 26, 2024
Meet The Calif. Atty Taking On Health Insurers' Use Of AI
With the health insurance industry under scrutiny over its use of algorithms and artificial intelligence in the patient coverage review process, California appellate attorney Glenn Danas saw an opening for litigation with what he calls a "high outrage factor."
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March 26, 2024
Healthcare Hack May Be Wake-Up Call For Industry And Gov't
The recent cyberattack that sabotaged vital billing and prescribing services operated by a UnitedHealth unit that processes roughly half the medical claims in the U.S. has highlighted the urgent need for providers in this critical sector to not only understand supply chain security risks, but also to work more closely with the federal government to combat these threats.
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March 25, 2024
Ga. Judge Slams Attys Over 'Incredible' House Arrest Request
A Georgia federal judge on Monday postponed the sentencing of a cybersecurity contractor convicted of hacking into a hospital's computer systems after tearing into his attorneys over their request for nearly five years of home confinement instead of prison, for which the judge found "no basis."
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March 22, 2024
$900M Trade Secrets Case Against Kaiser Foundation Flops
A California state judge has ruled that, after more than five years of litigation against the Kaiser Foundation, a pastor's small medical technology startup cannot "explain what was unique or secret about its conception for transmitting patient data" that was purportedly worth beyond $900 million.
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March 22, 2024
Final OK Sought For Economic Loss Deal In CPAP Recall MDL
Users of Philips' recalled CPAP breathing machines have asked a Pennsylvania federal judge to give her final OK to their $467.5 million settlement with the company to cover economic loss claims, arguing only a few objections to the deal remain.
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March 22, 2024
LifeCell Cleared Of Liability In NJ Strattice Hernia Mesh Trial
New Jersey state jurors on Friday cleared LifeCell of liability in a Kentucky woman's suit alleging the design of its Strattice surgical mesh is defective and caused a hernia to reoccur and ultimately resulted in "life-altering" surgery, giving the medical device company the first win in a venue with at least 93 pending cases with tort claims over the mesh.
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March 21, 2024
Colo. Distributor Seeks $2.3M Sanction For Stryker Spoilation
A Colorado medical device distributor urged a federal judge to make Stryker and its lawyers pay $2.3 million in attorney fees as sanctions for "pervasive misconduct" throughout discovery and trial, arguing discovery violations will otherwise become the "cost of doing business" for the medical technology giant.
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March 21, 2024
UpHealth Claims $110M Win In Glocal Control Fight
Global digital health company UpHealth Inc. says an arbitral panel has awarded it more than $110 million following a dispute that arose out of its subsidiary's acquisition of Glocal Healthcare Systems in 2020 — even as Glocal decried the award as "one-sided and perverse."
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March 21, 2024
Woman Lost Independence Due To Strattice Mesh, Jurors Told
A Kentucky woman told New Jersey state jurors on Thursday that LifeCell skipped important safety steps while designing its Strattice surgical mesh, and that those skipped steps caused a hernia to reoccur and ultimately resulted in the loss of her independence.
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March 21, 2024
Fed. Circ. Upholds Edwards' PTAB Win On Heart Valve Patent
The Federal Circuit has affirmed a Patent Trial and Appeal Board finding that various parts of medical technology maker Cardiovalve's patent on an artificial heart valve implant were invalid as obvious.
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March 18, 2024
Texas Hospital Loses Bid To Dismiss Patients' Hack Suit
A Texas federal judge handed a win to the plaintiffs suing a hospital system in the aftermath of a hack that saw hundreds of patients' data pilfered, dismissing some of the claims in the proposed class action but allowing the suit to move forward after a hearing Monday.
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March 14, 2024
Health Co. Says Future Harm Risk Falls Short In Breach Suit
New Jersey healthcare provider Capital Health System urged a Garden State federal judge on Wednesday to toss a proposed class action seeking damages as a result of a 2023 data breach, arguing that the plaintiffs failed to allege their personal identifying information was actually misused.
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March 13, 2024
HHS To Investigate Whether Cyberattack Exposed Patient Data
The U.S. Department of Health and Human Services opened an investigation Wednesday into the cyberattack on Change Healthcare to determine whether the hack exposed patients' confidential data or violated other privacy protections.
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March 13, 2024
Hospital Manager Cements $3.5M Gabon Arbitration Award
The Gabonese Republic must pay a $3.5 million arbitration award obtained by an Austrian healthcare management company, a D.C. federal judge ruled after the central African nation failed to appear in court.
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March 11, 2024
Biden Calls For More Cybersecurity Funding Across Agencies
The Biden administration on Monday pushed Congress to make significant monetary investments in efforts to bolster the federal government's cybersecurity posture, including by earmarking $13 billion to support initiatives across civilian agencies and devoting additional funding to help the U.S. Department of Health and Human Services combat a growing scourge of cyberattacks on healthcare providers.
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March 08, 2024
DOJ Eyes FCPA For New Whistleblower Rewards Program
U.S. Department of Justice officials on Friday signaled a renewed emphasis on fighting foreign corruption, saying its planned whistleblower rewards program should prove useful in Foreign Corrupt Practices Act cases against private companies, and warned companies against running afoul of new rules barring the sale of personal data to foreign adversaries of the U.S.
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March 08, 2024
Colo. DNA Scientist Fudged Data For 650 Cases, Police Say
A former DNA scientist for the Colorado Bureau of Investigation manipulated data for years, the bureau announced Friday, stating that an investigation has identified more than 650 cases affected since 2008.
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March 08, 2024
Ambrose Mills Adds IP Expert From Sterne Kessler In Virginia
Ambrose Mills & Lazarow PLLC, a corporate and IP boutique, has hired an intellectual property attorney from Sterne Kessler Goldstein & Fox LLP who focuses on patent matters and brings over a decade of experience, Ambrose Mills announced Thursday.
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March 08, 2024
Cybersecurity Co. Promotes Attys To GC, Chief People Officer
Florida-based cybersecurity company ReliaQuest announced it has promoted two of its in-house attorneys to general counsel and chief people officer.
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March 07, 2024
Wash. Justices Won't Hear Unions' Wage Clawback Case
Washington's highest court has rejected three unions' request for justices to decide how private employers may respond when they erroneously overpay employees, clearing the way for a jury to hear the case contesting a healthcare system's wage clawback after its payroll system was hit by a cyberattack.
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March 07, 2024
Sens. Tell Stores To Get Illegal E-Cigs Off Their Shelves
Five U.S. senators on Thursday told the heads of major convenience store and gas station chains to stop sales of unauthorized flavored e-cigarette products, saying that their illegal sales pose a major threat to public health, especially children's.
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March 07, 2024
Fed. Circ. Says IP License May Be Part Of Procurement Deal
The Federal Circuit on Wednesday revived a software developer's claims that the U.S. Food and Drug Administration misappropriated its data, saying the developer had sufficiently alleged it was party to a government contract that allowed lawsuits under the Contract Disputes Act.
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March 07, 2024
Moses & Singer Healthcare Atty Joins Day Pitney In Hartford
Day Pitney LLP has added an experienced attorney to its Hartford office as counsel from Moses & Singer LLP in New York.
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March 06, 2024
CBP Details Apple Watch Redesign OK In Masimo Patent Row
U.S. Customs and Border Protection has released its January decision finding that redesigned Apple Watches do not infringe Masimo Corp.'s blood oxygen monitor patents, explaining that while the new versions can access the patented feature, doing so requires "significant alteration."
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March 06, 2024
PTAB Has To Rehear Challenge In Biotech Row
A panel set up by U.S. Patent and Trademark Office Director Kathi Vidal has told the Patent Trial and Appeal Board it needs to redo its review of a fight between two biotech companies.
Expert Analysis
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How Merger Review Overhaul Could Affect Health Industry
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.
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What Circuit Split May Mean For FCA Kickback Liability
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.
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How Health Cos. Can Brace For Tracking Tech Scrutiny
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.
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Unpacking CMS' Latest Proposals For Telehealth Flexibilities
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.
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Wash. Class Actions Are Coming After My Health My Data Act
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.
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SEC Cybersecurity Rule Presents Burden For Health Care Cos.
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.
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Comparing US And EU Approaches To Health AI Regulation
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.
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Why Privacy And Trade Secret Law Are On A Collision Course
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.
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Negotiating AI-Life Sciences Partnerships To Minimize IP Risk
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.
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Parsing Through The FTC's Proposed Health Privacy Updates
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.
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Regulating AI: An Overview Of Federal Efforts
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.
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Compliance Takeaways From HHS Information Blocking Rule
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.
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Life Sci Cos. Should Work With FDA To Shape AI Regulation
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.