Digital Health & Technology
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June 28, 2024
In Chevron Case, Justices Trade One Unknown For Another
The U.S. Supreme Court's decision to overrule a decades-old judicial deference doctrine may cause the "eternal fog of uncertainty" surrounding federal agency actions to dissipate and level the playing field in challenges of government policies, but lawyers warn it raises new questions over what rules courts must follow and how judges will implement them.
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June 27, 2024
Fla. Gov. Vetoes Bill Giving Immunity On Data Breach Claims
Florida Gov. Ron DeSantis on Wednesday vetoed a bill that would have provided immunity from data breach lawsuits for businesses that complied with certain cybersecurity standards, citing concerns that the legislation could result in Floridians' data being less secure.
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June 27, 2024
High Court Allows Idaho Emergency Abortions, For Now
The U.S. Supreme Court on Thursday allowed abortions in Idaho to continue in emergency situations under a federal law requiring doctors at Medicare-funded hospitals to provide emergency care, including abortions.
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June 26, 2024
State Data Privacy Law Patchwork: Midyear Report
States jumped on the consumer data privacy law bandwagon at a brisk clip in the first half of 2024, although it remains unclear if this push will be enough to encourage Congress to finally enact a nationwide framework this year.
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June 26, 2024
Apple Watch Improvement Is 'Inferior,' Docs Tell 9th Circ.
Four cardiac specialists backed medical monitoring startup AliveCor against Apple in a Ninth Circuit amicus brief Tuesday arguing a district court wrongly nixed antitrust claims by crediting the phaseout of a heart rate monitoring algorithm as an improvement when all it did was deny patient access to "potentially life-saving" technology.
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June 25, 2024
Judge Likely To Block Medical Record Co.'s Anti-Bot CAPTCHAs
A Maryland federal judge appeared ready to enjoin electronic medical records company PointClickCare from restricting nursing home analytics company Real Time Medical Systems' automated access to its online repositories Tuesday, potentially taking an early crack at defining the 21st Century Cures Act's data sharing provisions.
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June 24, 2024
$2.9M Health Co. Data Breach Settlement Gets Final Approval
A Michigan federal judge has given final approval to a $2.9 million deal for a maker of prosthetics and orthotics to settle claims the company didn't protect customers' sensitive information from a cyberattack.
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June 20, 2024
Web-Tracking Guidance Exceeded HHS' Authority, Judge Says
A Texas federal judge ordered the Biden administration Thursday to rescind its new guidance restricting hospitals' use of online tracking technology, declaring that federal officials had overstepped their authority by redefining what they consider protected health information.
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June 18, 2024
Novant Pays $6.7M For Sharing Patient Data With Facebook
A North Carolina federal judge on Monday gave the final seal of approval to a proposed $6.7 million deal resolving litigation alleging Novant Health Inc. shared sensitive patient data with Facebook, certifying a nationwide settlement class of roughly 1.3 million individuals.
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June 18, 2024
COVID Test Maker Can't Shake All Of $30M Faulty Kit Suit
A New Jersey federal judge won't let California-based laboratory equipment maker Atila Biosystems Inc. out of a suit alleging it sold faulty COVID-19 testing kits, saying Fusion Diagnostic Laboratories LLC has adequately pled a breach of contract claim.
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June 18, 2024
Gene Therapy Co. Taps Experienced Bioscience Legal Chief
Kriya Therapeutics Inc., which develops gene therapies to address common diseases, said Tuesday it has chosen a veteran bioscience general counsel to be its chief legal officer.
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June 17, 2024
Calif. Becomes Last State To Ink Deal Over Blackbaud Breach
Blackbaud Inc. has agreed to pay $6.75 million to resolve data security claims brought by California's attorney general, who was the only one to sit out a nearly $50 million settlement that the software provider reached last year with every other state over a 2020 ransomware attack that affected thousands of its customers.
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June 17, 2024
Ex-Stimwave CEO Gets 6 Years For Dummy Implant Scheme
The founder and former CEO of Stimwave Technologies was sentenced to six years in prison Monday after tearfully proclaiming her innocence to healthcare fraud charges, with a Manhattan federal judge saying it's "sad" the defendant doesn't recognize the harm she inflicted by selling nonfunctional pain management device components.
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June 13, 2024
IP Forecast: Cooley Atty Faces DQ Bid Over Past Patent Work
A prominent Cooley LLP lawyer will face questions next week in a Philadelphia courtroom over her work a decade ago at her former firm defending a cloud software startup that is now suing a Cooley client. Here's a spotlight on that case — plus all the other major intellectual property matters on deck in the coming week.
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June 10, 2024
5 Teva Inhaler Patents Kicked Out Of Orange Book
A New Jersey federal judge said Monday that a handful of patents covering Teva-brand asthma inhalers were "improperly listed in the Orange Book," a legal holding that U.S. Federal Trade Commission Chair Lina Khan quickly took some credit for.
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June 10, 2024
Rehab Clinics Add To MultiPlan Insurance Fixing Pile-On
Addiction treatment providers sued MultiPlan, Aetna, Cigna, UnitedHealth and Elevance Friday and Saturday in 14 separate New York federal court complaints that appear to be the first to add substance abuse disorder-specific allegations to the cases pegging MultiPlan at the center of a scheme to suppress insurer payouts.
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June 10, 2024
Health Data Co. Says Rival's Request Risks Patient Security
A healthcare data company pushed back against claims in Maryland federal court that it blocks a rival's access to nursing home patient data used to identify potential complications, saying the rival is asking to disable security measures that prevent attacks on its system.
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June 10, 2024
Medical-Aesthetic Device Rivals Set For Sept. Poaching Trial
A Boston federal judge on Monday scheduled a post-Labor Day jury trial for medical-aesthetic device company Cynosure's $78 million poaching lawsuit against rival Reveal Lasers, urging the parties to streamline their exhibits and damages claims.
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June 07, 2024
DC Circ. Undoes Library Of Congress Win In Fair Use Fight
The D.C. Circuit on Friday reversed a lower court's decision that had rejected two industry groups' challenge to a final rule that categorized medical device diagnostic procedures and repairs as fair use exemptions to U.S. copyright law.
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July 03, 2024
The State Of The Retail Industry's Healthcare Investments
Amazon and Walgreens separately announced changes to their healthcare offerings, revealing the growing divide between retail companies as they grapple with a complicated business. Law360 Healthcare Authority looks at major retailers' recent healthcare ventures and where they stand now.
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June 04, 2024
Medical Board Group Keeps AI Liability Focus On Doctors
When emergency room nurses and doctors make split-second decisions using an artificial intelligence tool, who ultimately bears responsibility if a patient winds up harmed? Recent guidance from the Federation of State Medical Boards keeps the onus squarely on doctors.
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May 31, 2024
Samsung Strikes First With Smart Ring IP Suit Against Oura
Samsung has yet to announce a release date for its new Galaxy Ring brand of wearable, health-tracking devices, but it has filed an intellectual property suit in California federal court Thursday targeting a Finnish startup that makes its own line of smart rings.
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May 30, 2024
FTC, SEC Urged To Probe UnitedHealth's 'Negligent' Security
The chair of the U.S. Senate finance committee on Thursday pressed the Federal Trade Commission and the U.S. Securities and Exchange Commission to hold UnitedHealth Group and its top executives liable for "numerous" cybersecurity failings that fueled a debilitating cyberattack on its Change Healthcare unit.
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May 30, 2024
Veradigm Execs Sued Over Company's Nasdaq Delisting
Current and former members of healthcare technology company Veradigm Inc.'s top brass were sued in Illinois federal court by shareholders alleging that the company suffered stock drops following a string of financial reporting blunders starting in 2021, which caused it to overstate roughly $40 million in revenue before facing a delisting notice from Nasdaq.
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May 29, 2024
Greenberg Traurig Adds IP Atty From Eversheds Sutherland
Greenberg Traurig LLP has bolstered its California bench of attorneys with an Eversheds Sutherland lawyer who has years of experience advising digital health and medical device companies on intellectual property issues.
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 Law.
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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.