Digital Health & Technology
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January 10, 2025
1st Circ. Questions Reach Of Anti-Torture Law In Civil Cases
The First Circuit on Friday hinted it may be considering limits on the jurisdiction of the Torture Victims Protection Act, during a hearing where former Justice Stephen Breyer recalled concerns he first raised on the Supreme Court that an overly broad reading could pave the way for other nations to arrest Americans for incidents on U.S. soil.
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January 09, 2025
'Stunned': Judge Rips Atty For Violating Antitrust Trial Order
A California federal judge overseeing an antitrust jury trial over claims that Intuitive Surgical was a monopolist that abused its power by blocking hospitals from using a service to extend the life of a component related to its surgical-robot arms said Thursday she was "stunned" when plaintiff Surgical Instrument Service showed a video that violated a pretrial order.
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January 09, 2025
Cancer Org Fails To Get Rival's TM Counterclaims Tossed
A Georgia federal judge said Thursday that the Glioblastoma Foundation Inc. can't yet escape a series of counterclaims filed against it by a rival nonprofit amid a trademark spat, ruling that its defenses in a dismissal bid largely relied on factual issues about whether the rival fraudulently obtained the marks at issue.
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January 09, 2025
VITAS Must Face Wiretap Suit Over Customer Service Calls
A California federal judge declined to toss a putative class action alleging VITAS Healthcare violated wiretapping laws by helping a third-party software developer eavesdrop on calls with VITAS' customers, noting Wednesday the third party was capable of using the data derived from the calls for its own purposes.
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January 08, 2025
Intuitive Killed Biz For Reusing Robo-Surgery Arms, Jury Told
The president of a family-owned medical instrument repair business suing biotechnology company Intuitive Surgical on antitrust claims told a California federal jury Wednesday that his company saw a "huge opportunity" in providing a service that extended the life of Intuitive's surgical robot arms, but hospitals balked after Intuitive sent threatening letters.
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January 08, 2025
Patent Board Knocks Out Most Of Apple Patent
Two rulings out of the Patent Trial and Appeal Board have wiped out several claims in a patent Apple is asserting against a medical software company that was initially first to assert patents against Apple over health-related programming in the Apple Watch.
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January 08, 2025
Telligen's TM Suit Against IT Co. Can Move Forward
A California federal judge is letting a trademark lawsuit from health data company Telligen proceed against information technology company Telligens, ruling that he was not yet convinced that the suit was filed 10 years too late.
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January 08, 2025
Biotech Co.'s Facility Failures Lost Investors Money, Suit Says
The executives and directors of biotechnology company Humacyte Inc. have been hit with a shareholder derivative suit in North Carolina federal court alleging the company concealed that its manufacturing facility failed to comply with certain quality assurance practices, leading to delayed regulatory review for its product candidate.
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January 07, 2025
Robo Surgery Co. Gets Billions From Selling Parts, Jury Told
Surgical Instrument Service accused Intuitive Surgical at the start of a federal trial Tuesday of being a monopolist making billions of dollars by blocking hospitals from extending the life of reusable surgical-robot components, while Intuitive blasted the medical instrument repair company for "trying to misuse antitrust laws to enrich itself."
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January 07, 2025
HHS Fines Mass. Health Firm $80K Over Ransomware Attack
Elgon Information Systems, which provides digital medical record and billing support services, will pay $80,000 over alleged healthcare data protection rule violations following a ransomware attack on its systems in March 2023 that impacted roughly 31,248 customers, the U.S. Department of Health and Human Services announced Tuesday.
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January 07, 2025
HIPAA Cyber Rule Shake-Up Arrives On Eve Of Trump's Return
A massive cybersecurity rule change proposed this week would require healthcare providers and insurers to protect patient data with multifactor authentication and other safeguards. Attorneys are watching to see if the Trump administration changes course.
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January 06, 2025
Labcorp Loses Appeal Of Gene-Testing Patent In $372M Case
Labcorp, one of the world's largest chains of clinical lab providers, lost its appeal over a patent tied to a $372 million judgment it is facing in the Western District of Texas, after Federal Circuit judges on Monday upheld an administrative patent board ruling against it two years ago.
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December 20, 2024
Medical Records Co. Wants Rival's Antitrust Suit Tossed
Epic Systems Corp. told a New York federal court that an antitrust case lodged by Particle Health Inc. is really just payback for revealing concerns that Particle allowed its customers to inappropriately access personal medical records.
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December 20, 2024
Top Privacy & Cybersecurity Developments Of 2024
The state data privacy law patchwork continued to add new and varied pieces in 2024, while major hacks shook up the healthcare industry and other critical sectors, and the first U.S. laws setting guardrails for the use of artificial intelligence technologies emerged.
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December 19, 2024
Google Health Tracking Plaintiffs Fight To Keep Suit Alive
A California federal judge who was asked by Google to toss a proposed class action alleging that the tech giant illicitly scoops up users' personal data from healthcare providers' websites indicated during a Thursday hearing that he might grant the request while adding that he still has "a lot more thinking to do."
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December 17, 2024
UNC Doctor Can't Shield Minor Transgender Patients' Records
A University of North Carolina doctor cannot assert privilege over medical records sought from the university by state Republicans fighting a suit by the physician and others seeking to enjoin a law imposing limits on transgender care for minors, a federal magistrate judge has ruled.
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December 17, 2024
Stanford Profs Say Roche's Trade Secret Claims Time-Barred
Stanford University's trustees and three of its professors have asked a California federal court to dismiss trade secret theft claims bought by subsidiaries of F. Hoffmann-La Roche AG, arguing that the allegations are time-barred because the companies were on notice of the purported misappropriation for over three years before filing suit.
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December 17, 2024
New Fed Health Data Rules: What You Need To Know
The Biden administration this week established long-awaited regulations codifying how medical providers and vendors must share electronic health information. New provisions were included to thwart criminal investigations into reproductive healthcare.
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December 17, 2024
FDA Sharpens Focus On Celebrity Drug Endorsements
Ads featuring celebrities such as tennis star Serena Williams and interior designer Nate Berkus surfaced in FDA enforcement letters this year. The agency has ramped up its scrutiny of influencer drug promotion.
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December 11, 2024
Ga. Judge Refuses To Reconsider Toss Of Patient Data Suit
A Georgia federal judge has refused to reconsider the dismissal of a proposed class action alleging Piedmont Healthcare Inc. unlawfully shared patients' health data with Facebook via the company's tracking pixel tool.
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December 10, 2024
UpHealth Says Glocal Execs Stalling On $115M Award Suit
Digital health services company UpHealth has asked an Illinois federal judge to favor its efforts to pin down assets belonging to executives of Indian healthcare firm Glocal as it looks to enforce a $115 million arbitral award, saying the respondents are engaging in "obstructionist" conduct.
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December 06, 2024
Google Must Face Trimmed BIPA Suit Over IBM Dataset
A California federal judge on Thursday permitted Illinois residents to proceed with a pared-down version of their proposed class action accusing Google of violating biometric privacy laws with facial data collected by IBM, ruling they've adequately alleged a violation of the Illinois Biometric Privacy Act.
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December 06, 2024
NC Hospital Gets Initial OK For $1.1M Data Breach Deal
A North Carolina Business Court judge has given his initial seal of approval to a $1.1 million settlement agreement in a data breach class action against Columbus Regional Healthcare System.
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December 06, 2024
Colo. Children's Hospital Fined $548K For Phishing Attacks
Children's Hospital Colorado was hit with a more than $548,000 fine over phishing and cyberattacks that violated patient privacy rules, according to the U.S. Department of Health and Human Services.
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December 05, 2024
Pain Management Clinic Fined $1.19 Million for HIPAA Breach
The U.S. Department of Health and Human Services has fined a Florida pain management clinic $1.19 million for alleged HIPAA violations involving a former contractor that impermissibly accessed the clinic's electronic record system.
Expert Analysis
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3 Tips For Defending Against Data Breach Litigation
As cyberattacks become more prevalent, companies responding to data breaches must consider several strategies to better position themselves in the event of litigation even during their preliminary investigations and breach notifications, say attorneys at Davis Wright.
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What Pharma Cos. Must Know About FDA Off-Label Guidance
The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.
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It's Time To Prescribe Frameworks For AI-Driven Health Care
As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.
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FDA Proposals Clarify Rules For Devices With Predicates
As medical devices continue to grow in complexity, U.S. Food and Drug Administration policies surrounding premarket submissions for devices with existing predicates have fallen behind, but new draft guidances from the agency help fill in some gaps, say attorneys at Hogan Lovells.
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How Int'l Regulatory Collabs Can Expedite Pharma Approvals
Recent announcements highlight the growing importance of international regulatory collaboration for drug approval, which can greatly streamline the process for companies seeking to market their drugs in other countries, say Geneviève Michaux and Christina Markus at King & Spalding.
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Why Standing Analysis Is Key In Data Breach Mediation
Amid a growing wave of data breach class action litigation, recent legal developments show shifting criteria for Article III standing based on an increased risk of future identity theft, meaning parties must integrate assessments of standing into mediation discussions to substantiate their settlement demands in data breach class actions, says Abe Melamed at Signature Resolution.
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2 New Ways FDA Is Changing Lab-Developed Test Regulation
The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.
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FDA's Lab-Developed Test Rule Faces High Hurdles
The U.S. Food and Drug Administration's recently announced plans to explicitly regulate lab-developed tests will likely face resistance from industry stakeholders and congressional actions, and lead to significant litigation, say attorneys at Hogan Lovells.
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FDA's Drug Software Draft Guidance Raises New Questions
The U.S. Food and Drug Administration's long-awaited draft guidance regarding regulatory considerations for prescription drug use-related software functions as an informative starting point for developers, but many new and lingering questions must be answered before the regulatory limbo is resolved, say attorneys at King & Spalding.
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A Topic-Based Analysis Of FDA Responses To FOIA Requests
By using a topic modeling method, it's possible to discern the major recurring topics in Freedom of Information Act requests made to the U.S. Food and Drug Administration, as well as the likelihood of success for individual topics, says Bradley Thompson at Epstein Becker.
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State Privacy Laws: Not As Comprehensive As You May Think
As more U.S. states enact privacy laws, companies must be aware that these laws vary in scope and content, meaning organizations should take a stringent approach to compliance by considering notice, choice and data security obligations, among other requirements, says Liisa Thomas at Sheppard Mullin.
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Concerns For 510(k) Sponsors After FDA Proposes Major Shift
While there may be public health benefits from modernizing the 510(k) process for clearing medical devices, recent draft guidance from the U.S. Food and Drug Administration's Center for Devices and Radiological Health leaves meaningful open questions about the legal and regulatory implications of the new approach, and potential practical challenges, say attorneys at Covington.
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Address The Data Monopoly, Otherwise Tech Giants Control AI
It is likely that we will experience a severe monopoly on artificial intelligence systems and patents by the largest players in the tech industry, so the way we treat data needs to change, whether through the legislature, the courts or tech companies, says Pranav Katti at Barclay Damon.