Digital Health & Technology
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May 22, 2025
Calif. Docs Bring FDA Stem Cell Regulation Fight To Top Court
Two California clinics that provide stem cell treatments are urging the U.S. Supreme Court to review a Ninth Circuit panel's finding that their treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations.
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May 20, 2025
Flo Users Get Class Cert. In Google, Meta Data-Sharing Suit
A California federal judge has granted class status to users of the menstrual cycle tracking app developed by Flo Health Inc. in a suit accusing the company of unlawfully sharing their personal health information with Google and Meta, finding that the defendants' opposition to this move lacked clarity and support.
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May 20, 2025
Medical Organizations Sue Feds For Removing Health Data
The U.S. Department of Health and Human Services and several constituent agencies are accused of violating the Administrative Procedure Act by illegally purging websites containing critical public health information related to trans and HIV care, vaccines and the prevention of outbreaks of communicable diseases, according to a lawsuit filed Tuesday in Washington federal court.
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May 20, 2025
Biotech Stockholders Challenge Director Pay Levels In Del.
Investors in biotech company Intellia Therapeutics Inc. stock opened a derivative suit in Delaware's Court of Chancery on Tuesday seeking recovery of allegedly excessive compensation paid to non-employee directors for multiple years without an approval vote by stockholders.
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May 20, 2025
Sales Exec Admits Role In $70M Brain Scan Kickback Scheme
A former operations and regional sales manager for a mobile medical diagnostic company has agreed to plead guilty to taking part in a $70.6 million conspiracy to pay kickbacks to doctors who ordered unnecessary brain scans, Massachusetts federal prosecutors announced Tuesday.
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May 20, 2025
NYU Langone IT Workers Get Conditional Cert. In Wage Suit
Information technology workers who accused New York University's academic medical center of improperly classifying them as exempt from earning overtime wages can proceed as a collective, a federal judge ruled, finding they showed they were all subject to the same pay policies and practices.
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May 20, 2025
Foreign Drugmakers Brace For More Visits Amid FDA Cuts
The U.S. Food and Drug Administration's plan to expand surprise inspections of overseas drug manufacturing plants is a legitimate enforcement threat that should be taken seriously, even as the agency adjusts to a future with a smaller workforce.
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May 16, 2025
Surgical Center Operator Inks $15M Deal Over Data Breach
Shields Health Group Inc., which runs dozens of MRI and surgical centers around New England, has agreed to pay around $15 million to resolve claims in a proposed class action stemming from a data breach that compromised the personal information of over 2 million people.
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May 15, 2025
Zuckerberg Can't Avoid Deposition In Meta Health Privacy Suit
A California federal judge on Wednesday refused to rethink her earlier order forcing Meta CEO Mark Zuckerberg to give a limited deposition in privacy litigation over a Facebook tool's alleged collection of patient health information, rejecting Meta's arguments that other executives are better suited to testify.
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May 14, 2025
Health Co. Founder Pleads Guilty In $5M Fraud Case
A Florida man who operated a health monitoring company geared toward keeping substance-addicted people from relapsing has admitted to bilking investors out of $5 million by misstating interest in the firm, the U.S. attorney's office in Philadelphia said.
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May 14, 2025
Virta Health's Diabetes Mission Is Personal For Its GC
Jamie Anderson said it's important to find a mission-driven company to join — and when that mission aligns with an attorney's personal life, it's even more inspiration to work hard and contribute to the success of the business.
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May 13, 2025
Becton Dickinson Sues Baxter Over Infusion Pump Patents
Becton Dickinson has accused Baxter International of willfully infringing six of its patents for infusion pump technologies used to deliver medications to patients, telling a Delaware federal court that marketing materials for a Baxter infusion pump platform touted several Becton inventions.
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May 13, 2025
4 Firms Seek $5M In $6.75M Seattle Hospital Web Privacy Deal
An unnamed plaintiff is urging a Washington state judge to give final blessing to an up to $6.75 million settlement to end allegations that a Seattle hospital system deployed source code on its website that divulged patients' private health information to Google and Facebook, with class counsel requesting another $5 million in fees.
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May 13, 2025
Split PTAB Cites SAS To Reject Samsung Petition
The Patent Trial and Appeal Board will not review whether a real-time interpretation patent for those hard of hearing is invalid after finding that only a quarter of Samsung's challenge could be successful, which isn't worth the full trial mandated by the U.S. Supreme Court.
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May 13, 2025
Telehealth Coalition Director Talks Abortion Drug Battles
Since the overturning of Roe, abortion medications have become the most common method in the U.S. of ending a pregnancy. A co-founder of the Abortion Coalition for Telemedicine talks about the new legal battles over mifepristone, state shield laws, and a colleague facing criminal charges for sending abortion drugs through the mail.
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May 13, 2025
Former J&J, Moderna Exec Joins Goodwin Procter In Boston
Goodwin Procter is continuing to grow its resources in the life sciences practice with the recent addition to the Boston office of an attorney who has gone back to private practice after more than seven years as an in-house counsel for Johnson & Johnson and Moderna.
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May 12, 2025
Will Justices Finally Rein In Universal Injunctions?
The U.S. Supreme Court is expected to address for the first time Thursday the propriety of universal injunctions, a tool federal judges have increasingly used to broadly halt presidential orders and policy initiatives, and whose validity has haunted the high court's merits and emergency dockets for more than a decade.
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May 12, 2025
AI Powers Next Wave Of Telehealth M&A After 2024 Uptick
Telemedicine-focused deal activity is poised for a transformative shift in 2025 as strategic buyers increasingly seek companies that embed artificial intelligence across their platforms, according to a new report from tech investment bank Drake Star.
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May 07, 2025
FDA Gets Win In Eli Lilly Weight Loss Drug Shortage Fight
A Texas federal judge on Wednesday refused to reverse a U.S. Food and Drug Administration decision to remove Eli Lilly & Co.'s popular weight loss drug from a national shortage list, denying a request from pharmacies that produce copycat doses of the drug and entering judgment in favor of the FDA.
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May 07, 2025
Masimo Unloads Embattled Audio Unit In $350M Sale
Samsung Electronics subsidiary Harman International has agreed to acquire Masimo Corp.'s consumer audio division, Sound United, for $350 million in cash, with Masimo taking a financial hit on the business it acquired three years ago for about $1 billion.
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May 05, 2025
High Court Won't Hear Challenge To Miss. Ban On Pot Ads
The U.S. Supreme Court on Monday rejected an opportunity to hear a First Amendment challenge to Mississippi's policy outlawing medical marijuana advertisements, effectively preserving a circuit court decision that upheld the state's ban.
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May 02, 2025
Boston Scientific, FDA Sued Over 'Unsafe' Spinal Implant
Boston Scientific evaded safety regulations to market a defective spinal cord stimulator and the U.S. Food and Drug Administration rubber-stamped those alterations in an instance of "agency capture," according to a California federal lawsuit filed by a patient suffering from ongoing pain after the device was implanted.
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May 01, 2025
DaVita Hit With Class Actions Over Ransomware Attack
DaVita Inc. is facing at least two proposed class actions over a data breach the kidney care provider announced in April, with current and former patients alleging Wednesday in Colorado federal court that data thieves have already engaged in identity theft and fraud while DaVita has yet to offer details.
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May 01, 2025
US Tells Justices Telemedicine Case Isn't Ideal For Eligibility
The Justice Department is urging the U.S. Supreme Court to reject a petition over the eligibility of telemedicine patents it's accused of infringing, but it said that if the petition is granted, it plans to argue the patents shouldn't have been invalidated as abstract.
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May 01, 2025
Meet The Attys Helping Chiaro Seek Ch. 15 Recognition
British women's healthtech company Chiaro Technology Ltd. is relying on three attorneys from DLA Piper LLP as it seeks recognition of its insolvency in the United Kingdom by a Delaware bankruptcy court.
Expert Analysis
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10 Practical Takeaways From FDA's Biopharma AI Guidance
Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.
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How Health Cos. Can Navigate Data Security Regulation Limbo
Despite the Trump administration's freeze on proposed updates to the Health Insurance Portability and Accountability Act security rule, there are critical cybersecurity steps healthcare organizations can take now without clear federal guidance, says William Li at Axiom.
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Rethinking 'No Comment' For Clients Facing Public Crises
“No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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Dispelling 10 Myths About Health Provider-Based Compliance
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Congress appears intent on requiring hospitals to submit provider-based attestations for all off-campus outpatient hospital locations, so now is the time for hospitals to prepare for this change by understanding common misconceptions about provider-based status and proactively correct noncompliance, say attorneys at McDermott.
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.
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2024 Was A Significant Year For HIPAA Compliance
The Office of Civil Rights' high level of Health Insurance Portability and Accountability Act activity in 2024 and press releases about its specific focus on certain cybersecurity issues make it abundantly clear that the OCR is not going to tolerate widespread compliance complacency, says Nathan Kottkamp at Williams Mullen.
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Liability Risk For AI In Medical Devices Demands Greater Care
As regulators push for legal reform surrounding artificial intelligence and cases implicating product liability for AI in medical technology continue to rise, manufacturers must adapt and implement new strategies to accommodate evolving risks, say attorneys at Crowell & Moring.
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6 Predictions For Cyber Risk And Insurance In 2025
This year is likely to bring with it some thorny and expensive cyber challenges, including increased ransomware activity, more data breach class actions and continued efforts to define business interruption loss calculations, say attorneys at Wiley.
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Health Tech Regulatory Trends To Watch In 2025
With an upcoming change in administration and the release of some long-awaited rules, the healthcare industry should prepare for shifting trends, including a growing focus on health data and interest in technology-enabled delivery of healthcare, say attorneys at Orrick.
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Balancing Health Tech Advances And Clinical Responsibility
To maintain their clinical responsibilities and mitigate potential legal risk, health professionals should incorporate the benefits of new medical technology powered by artificial intelligence while addressing its risks and limitations, says Kathleen Fisher Enyeart at Lathrop GPM.
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Navigating Decentralized Clinical Trials With FDA's Guidance
The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.
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What To Expect Next From Federal Health Tech Regulation
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Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.
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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.