Digital Health & Technology

  • September 27, 2024

    9th Circ. Says Stem Cell Treatment Not Exempt From FDA Rule

    Two California clinics' experimental stem cell treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations, the Ninth Circuit ruled Friday, reviving the federal government's bid to stop the clinic from marketing the products as cures for certain diseases without U.S. Food and Drug Administration review.

  • September 26, 2024

    HHS Flags Ransomware Rise In New Deal With Wash. Provider

    A Washington state-based healthcare provider has agreed to pay $250,000 and boost its data security to resolve the U.S. Department of Health and Human Service's enforcement action over a 2017 ransomware attack, amid what the agency said has been a steep rise in reports of such cyberattacks over the past six years. 

  • September 26, 2024

    Senate Bill Calls For Stronger Healthcare Cyber Standards

    Democratic lawmakers introduced legislation Thursday aiming to better protect patient health information and avoid cyberattacks by strengthening cybersecurity standards, months after a highly publicized data breach earlier this year of a UnitedHealth unit that lacked basic security measures like two-factor authentication.

  • September 25, 2024

    UpHealth Wins Most Of $115M Award In Glocal Merger Dispute

    Bankrupt digital health services company UpHealth can enforce a large part of a $115 million arbitral award against the Indian healthcare services platform Glocal in their feud over an ill-fated merger, an Illinois federal judge has ruled.

  • September 25, 2024

    Buffalo-Based Cyber Law Pro Joins Pierson Ferdinand

    Fast-growing virtual law firm Pierson Ferdinand LLP announced that an experienced cybersecurity attorney with a focus on the healthcare industry joined as a partner based in Buffalo, New York.

  • September 24, 2024

    Google Can't Ditch Privacy Suit Over Period App Data Sharing

    A California federal judge has refused to release Google from a proposed class action alleging the company used a data analytics tool to wrongfully retrieve data from menstruation tracking app Flo, rejecting the tech giant's arguments that the plaintiffs lacked standing and had consented to the disclosures. 

  • September 24, 2024

    Philips Must Face Investor Suit Over FDA Compliance Issues

    Health technology company Koninklijke Philips and its former CEO cannot escape a suit accusing them of misleading investors about the safety and compliance of its subsidiary's sleep and respiratory care products, which were recalled in 2021, but its chief financial officer and a former CEO of a Philips subsidiary were allowed to exit the case for good.

  • September 24, 2024

    Healthcare's AI Integration Is In Limbo As Laws Lag Behind

    As healthcare organizations look to incorporate artificial intelligence into their systems, they're coming across a unique problem: They're ahead of the rules.

  • September 24, 2024

    2nd Circ. Partly Revives Suit Over $18.5B Telehealth Deal

    The Second Circuit on Tuesday partially revived a suit against telehealth company Teladoc Health Inc. brought by investors who claim they were misled about the status of its integration with Livongo following their $18.5 billion merger.

  • September 23, 2024

    Medical Records Co. Accused Of Blocking Data Access

    A company that helps insurance providers access patient data on Monday accused medical records company Epic Systems Corp. of violating antitrust law by using its monopoly over electronic health records to squash an emerging competitor.

  • September 20, 2024

    Fla. Judge Trims Health Co. Data Breach MDL

    The Florida federal judge overseeing the multidistrict litigation of a health benefits administration company impacted by a data breach dismissed several state consumer law claims but said those who brought lawsuits can sue, saying they've plausibly alleged injuries after their personal information was allegedly stolen by a cybercriminal group.

  • September 19, 2024

    Outcome Exec Who Flipped Gets 7 Months For $1B Fraud Role

    A former Outcome Health sales chief who was charged with helping to carry out a $1 billion fraud, but cooperated early and testified against his co-defendants, received seven months in prison Thursday for his role in the scheme.

  • September 17, 2024

    HIMSS Legal Chief Reflects On Balancing AI, Legal Risk

    As artificial intelligence finds itself taking up a large role in the healthcare industry, experts say they're watching closely to see how potential regulations are set to shape the industry, especially as the technology is expected to outpace legal frameworks.

  • September 13, 2024

    The 2024 Regional Powerhouses

    The law firms on Law360's list of 2024 Regional Powerhouses reflected the local peculiarities of their states while often representing clients in deals and cases that captured national attention.

  • September 13, 2024

    23andMe Inks $30M Data Breach Deal With 6.4M Users In MDL

    Personal genomics company 23andMe has reached a $30 million settlement to resolve multidistrict class action litigation on behalf of more than 6 million customers whose personal data was stolen and in some cases leaked onto the dark web, according to a California federal court filing Thursday.

  • September 11, 2024

    Health Co. Owes $65M For Breach Of Medical Data, Nude Pics

    Pennsylvania-based healthcare company Lehigh Valley Health Network will pay $65 million to individuals who had their private information, including cancer patients' nude images, exposed in a data breach, the plaintiffs' lawyers announced Wednesday.

  • September 10, 2024

    Amazon Must Trim 'Halo' TM For EU Market

    Amazon Technologies could not convince the EU's intellectual property office to let it register trademarks for "halo" unscathed, with the office backing a Californian health technology company's bid to trim key protections for medical monitoring devices and health assessment services.

  • September 10, 2024

    Nelson Mullins Adds Baker Donelson Health Pro In Houston

    Nelson Mullins Riley & Scarborough LLP has continued expanding a Houston shop that opened months ago by bringing on a healthcare attorney from Baker Donelson Bearman Caldwell & Berkowitz PC whose wide-ranging practice has included representing hospitals and other providers on cybersecurity and related issues.

  • September 09, 2024

    House OKs Bill To Bar Contracts With Chinese Biotech Cos.

    Driven by concerns about U.S. genetic data being shared with the Chinese government, House lawmakers passed a bill on Monday to bar federal agencies from buying certain biotechnology linked to the Chinese government or from contracting with firms that use those products.

  • September 06, 2024

    Glioblastoma Org. Wants End To Rival's Use Of 'GBM'

    The Glioblastoma Foundation has hit a competing nonprofit with a suit alleging that the group's use of the initials "GBM" in its name has ripped off its trademark and sown confusion among donors who can't tell the two organizations apart.

  • September 05, 2024

    Nvidia, Microsoft Face Patent, Cartel Allegations In Texas Suit

    A new lawsuit accuses Nvidia of holding "monopoly power" over the market on graphics processing in the artificial intelligence space and alleges the tech company is colluding with Microsoft and a prominent patent risk management company to squeeze out a small startup that claims to have developed the "fundamental intellectual property" behind that technology.

  • September 05, 2024

    Lawmakers, AGs Urge Justices To OK Denial Of E-Cig Apps

    A coalition of state attorneys general and a group of Democratic Congress members are backing the U.S. Food and Drug Administration in its fight to persuade the U.S. Supreme Court to overturn a decision striking down the denials of applications to market flavored vapes.

  • September 04, 2024

    Ill. Panel Backs Atty's Bid To Litigate Medical Record Fee Suit

    An Illinois attorney looking to hold document delivery service Ciox Health LLC liable for charging allegedly illegal fees can pursue those claims in court since there is no evidence he ever agreed to arbitrate disputes with the company, a state appellate panel said Tuesday.

  • September 04, 2024

    Trade Group Urges Court To Toss FDA Lab-Test Rule

    A clinical-lab trade group and an infectious disease laboratory that sued the U.S. Food and Drug Administration over its new final rule on laboratory-developed tests are asking a federal court to vacate it, saying Congress didn't grant the agency such power. 

  • September 03, 2024

    Aesthetic Laser Co. Tells Jury Of Rival's 'Corporate Raid'

    Medical aesthetic business Cynosure told a Boston federal jury Tuesday that two former employees and an industry rival launched a "calculated corporate raid" by poaching dozens of sales and marketing personnel, violating a host of noncompete and non-solicitation agreements while the departing workers pocketed trade secrets on their way out the door.

Expert Analysis

  • Negotiating AI-Life Sciences Partnerships To Minimize IP Risk

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    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.

  • Parsing Through The FTC's Proposed Health Privacy Updates

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    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.

  • Regulating AI: An Overview Of Federal Efforts

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    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.

  • Compliance Takeaways From HHS Information Blocking Rule

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    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.

  • Life Sci Cos. Should Work With FDA To Shape AI Regulation

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    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.

  • BIPA, Meta Pixel Suits Could Reshape Cybersecurity Litigation

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    Businesses and attorneys should watch several pending electronic privacy cases that revolve around disclosure of protected personal information and health data, which may shape how courts handle damages and class actions in the future of cybersecurity litigation, say Kelly Johnson and Melanie Condon at Goldberg Segalla.

  • The Double-Edged Sword Of Using ChatGPT In Health Care

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    While ChatGPT has shown promising potential in health care, one of the key challenges for players in this space is balancing patient privacy and data protection with the benefits of utilizing this technology, say attorneys at Sheppard Mullin.

  • Addressing Legal Issues Raised By AI Use In Health Care

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    With the usage of artificial intelligence and machine learning in health care likely to be governed by a patchwork of state laws for the near future, industry actors should build flexibility into products to meet evolving regulatory concerns, including monetization of patient data and professional licensing questions, say Sara Shanti and Phil Kim at Sheppard Mullin.

  • New Health Data Compliance Considerations For Pa. Lawyers

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    Given the regularity with which attorneys handle private health information, it is important for Pennsylvania firms to understand recent significant amendments to the state's data breach law, which address information not currently covered by federal law, says Mark Mattioli at Post & Schell.

  • Mitigating Risks Of Developing Drugs And Devices With AI

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    As the use of artificial intelligence in drug and medical device development advances, companies should implement five key steps to identify and mitigate areas of potential risk before regulatory frameworks catch up, say attorneys at King & Spalding.

  • Scope Of FTC's Health Info Enforcement May Expand

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    The Federal Trade Commission's proposed amendments to the Health Breach Notification Rule signal the agency's mounting efforts to regulate consumer health information beyond the reaches of the Health Information Portability and Accountability Act, which does not cover many recent health apps and technologies, say Jodi Daniel and Brandon Ge at Crowell & Moring.

  • How Attys Can Avoid Exposing Their Firms To Cyberattacks

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    Attorneys are the weakest link in their firms' cyberdefenses because hackers often exploit the gap between individuals’ work and personal cybersecurity habits, but there are some steps lawyers can take to reduce the risks they create for their employers, say Mark Hurley and Carmine Cicalese at Digital Privacy & Protection.

  • Rare FDA Move Shows Stance On Remote Monitoring Devices

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    The U.S. Food and Drug Administration's recent warning letter to iRhythm Technologies represents a relatively unprecedented degree of scrutiny to the remote monitoring device industry, say attorneys at Sheppard Mullin.