Digital Health & Technology
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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.
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May 28, 2024
Pharmacy Benefits Co. Taps Health Atty To Lead Legal Team
RxBenefits, a company focused on generating savings for employers providing pharmacy benefits, has appointed a new chief legal officer to oversee its legal and regulatory compliance efforts.
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May 24, 2024
Fla. Lab Owner Will Pay $27M To End False Billing Suit
A Florida medical lab owner who pled guilty to charges related to accusations he billed Medicare for $53 million in unnecessary genetic cancer screening tests has agreed to pay more than $27 million to resolve three whistleblower suits over the same conduct, according to an announcement Friday from the U.S. Department of Justice.
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May 23, 2024
Stryker Unit And Seyfarth Attys Hit With $275K Sanctions
A Colorado federal judge has imposed $275,000 in sanctions jointly and severally on Stryker-owned Howmedica Osteonics Corp., along with Seyfarth Shaw LLP, for witness coaching and discovery violations in a bitter breach-of-contract dispute, amounting to roughly one-eighth of what plaintiff ORP Surgical LLC had sought.
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May 22, 2024
Stryker Agrees To Settle Calif. Misclassification Suit
Medical device company Stryker told a California federal court Wednesday it has agreed to settle a proposed class action accusing it of misclassifying workers as overtime-exempt and failing to pay them overtime during their mandatory training.
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May 22, 2024
Lead Blood Test Maker To Plead Guilty, Pay $42M Over Defects
Medical device maker Magellan Diagnostics has agreed to pay at least $42 million and plead guilty to hiding a defect in its blood testing devices for lead that caused inaccurately low results for tens of thousands of children and others, Massachusetts federal prosecutors said.
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May 21, 2024
Amid Abortion Suit, Ind. Officials Spar Over Report Releases
Indiana's top lawyer is set to respond to a lawsuit seeking access to doctor-created abortion reports. The case promises to highlight a rift between the state's vocally anti-abortion attorney general and other officials who say the information is off-limits to public records requests.
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May 21, 2024
Strategic Hiring Was The New Normal For BigLaw In 2023
The 400 largest law firms by headcount in the U.S. grew more slowly in 2023 than in the previous two years, while Kirkland & Ellis LLP surpassed the 3,000-attorney threshold, according to the latest Law360 ranking.
Expert Analysis
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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.
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How SEC And NY Cyber Reporting Rules Affect Key Industries
The new U.S. Securities and Exchange Commission and New York State Department of Financial Services cybersecurity disclosure requirements, and their competing obligations, reveal the increasing complexity for organizations evaluating and reacting to cybersecurity incidents — particularly those in the healthcare and financial services industries, say attorneys at Manatt.
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In The World Of Legal Ethics, 10 Trends To Note From 2023
Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.
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5 Steps For Healthcare Companies After Biden's AI Order
Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.
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The Basics Of Law Firm Cyber Liability Insurance Applications
Cyber liability insurance has become a common consideration for law firms as cyber threats have escalated, but these insurance forms can be quite complicated given the nature of the industry and associated risks, so simply filling out the form won't necessarily result in an ideal policy for your firm, says Kevin Haight at WAMS.
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AI Brings New Insurance Concerns For Healthcare Providers
As the healthcare industry increasingly invests in medical artificial intelligence tools, it confronts a variety of liability risks that necessitate careful consideration and potential recalibration of providers' insurance programs, say Marialuisa Gallozzi and Megan Mumford Myers at Covington.
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Writing Thriller Novels Makes Me A Better Lawyer
Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.
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White House Activity Is A Band-Aid For Regulating AI In Health
In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.
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How Legal Teams Can Prep For Life Sciences' Tech Revolution
The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.