Digital Health & Technology

  • April 24, 2025

    4th Circ. Won't Rehear Health Data Access Order Challenge

    The Fourth Circuit has declined an electronic medical records firm's request for the appellate court to rethink a panel's decision to dismiss its appeal of an order forcing the company to let a nursing data business access its patient information.

  • April 22, 2025

    23andMe Has Received 'Significant Interest' In Ch. 11 Auction

    Genetic testing company 23andMe has received significant interest in the Chapter 11 auction for its assets, its counsel told a Missouri bankruptcy judge Tuesday at a hearing where it received final approval of a $35 million financing package to fund its bankruptcy case.

  • April 21, 2025

    Dental Practices Say Ex-Contractor Holding Websites Hostage

    A group of pediatric dental practices in North Carolina have accused their longtime business consultant of "hijacking" several website domains after they canceled his contract, saying he's trying to use the domains as leverage in unrelated negotiations.

  • April 17, 2025

    Planned Parenthood Patients Sue Lab Co. Over Data Breach

    A Washington state-based diagnostic testing services provider for Planned Parenthood has been hit with a pair of proposed class actions in Seattle federal court over an October data breach that reportedly impacted as many as 1.6 million people.

  • April 17, 2025

    9th Circ. Revives Defect Suit Against CR Bard Over Clot Filter

    The Ninth Circuit on Thursday revived a patient's allegations that C.R. Bard's blood clot-preventing IVC filter was defective, ruling that a lower court was wrong to throw out the suit as untimely since there are factual disputes as to when the patient noticed the filter had malfunctioned.

  • April 16, 2025

    Blue Shield Of California Sued Over Google's Patient Data Use

    Blue Shield of California was slapped with a putative class action in California state court Monday, days after the health insurer announced that the personal data of some of its patients had been "impermissibly" shared due to its use of Google Analytics on its websites.

  • April 15, 2025

    Pharma Tech Firm Hit With Class Claims Over Data Breach

    Pharmacy technology company CPS Solutions LLC allegedly failed to implement "basic data security practices" like encrypting patient information before a cybercriminal got into its email system in December, according to a new proposed class action filed in Ohio federal court.

  • April 15, 2025

    Former In-House Health Atty Joins Pierson Ferdinand

    Ben Hefflinger, a new healthcare partner at Pierson Ferdinand, talks to Law360 about the move from an in-house role to private practice at an "awesome intersection" for digital health.

  • April 15, 2025

    Will Trump Admin. 'Wash Its Hands' Of FDA Lab-Test Rule?

    A federal court decision that laboratory-developed tests fall outside the FDA's oversight puts the Trump administration at a juncture where it will have to decide how — or whether — to argue for expanded agency authority. Many expect Trump officials to take a pass.

  • April 14, 2025

    Juul Seeks Ax of Noncompliant Plaintiffs In E-Cig Suits

    Juul on Monday asked a California federal judge to toss claims brought by plaintiffs who failed to comply with court orders, about two years after Juul reached a $255 million global settlement in the litigation.

  • April 14, 2025

    Women's Healthtech Co. Chiaro Files Ch. 15 In Delaware

    British women's healthtech company Chiaro Technology Ltd. has filed for Chapter 15 recognition in Delaware bankruptcy court, seeking acknowledgment of an insolvency proceeding in the United Kingdom through which it aims to manage its American assets while pursuing a sale to a competitor.

  • April 11, 2025

    Dentsply Brass Face Investor Suit Over Alleged Dental Injuries

    Executives and directors of dental supply manufacturing company Dentsply Sirona Inc. have been hit with a derivative suit alleging they concealed that a company subsidiary was approving unsuitable patients for dental treatments to inflate sales figures.

  • April 11, 2025

    Telehealth Co. Sued Over 2024 Data Breach

    A company that helps healthcare providers manage after-hours patient calls was hit with a proposed class action in New York federal court Friday alleging that it failed to secure user data prior to a 2024 breach that exposed the sensitive information of nearly 1 million people.

  • April 09, 2025

    23andMe Asks For Independent Customer Data Rep In Ch. 11

    Genetic testing company 23andMe asked a Missouri bankruptcy judge to let it appoint an independent customer data representative as it looks to sell genetic data of 15 million users at a Chapter 11 auction.

  • April 07, 2025

    Fla. Man Pleads Guilty In $8.4M Medicare ID Fraud Case

    A Fort Lauderdale man has pled guilty in Florida federal court to criminal charges accusing him of illegally buying Medicare identification numbers and using those numbers to help submit $8.4 million in false Medicare claims.

  • April 03, 2025

    Hospital Group Urges 4th Circ. To Undo Data Access Order

    Industry groups representing hospitals and health data companies have urged the Fourth Circuit to rethink its panel's dismissal of an appeal over an order forcing an electronic medical records company to let a nursing data company access patients' information, saying the order creates a financial burden on the healthcare system.

  • April 02, 2025

    Congress Demands VA Update Health Record System Costs

    A bipartisan group of congressional leaders has sent a letter demanding that the U.S. Department of Veterans Affairs update its schedule and cost estimate for its problem-ridden, multibillion-dollar electronic health record modernization program, just as the VA announced it would roll out the system to nine additional sites in 2026.

  • April 02, 2025

    Zoll Gets Parts Of Data Breach Class Action Tossed

    A Massachusetts federal judge released Zoll Medical Corp. from some claims brought by a proposed class of medical device customers whose personal data was released after two ransomware attacks, but kept alive claims of negligence, unjust enrichment and others.

  • April 02, 2025

    Orthodontic Software Co. Hit With Data Breach Class Action

    An orthodontic software company has been hit with a proposed class action in Georgia federal court over a November data breach in which the names, birth dates, medical records, insurance information, payment card data and Social Security numbers of its clients' patients were stolen by hackers.

  • April 01, 2025

    The Loss For Litigants In Federal LGBTQ Data Rollback

    Brad Sears of UCLA School of Law’s Williams Institute talks about the fight to expand LGBTQ representation in federal datasets and the threat to litigants if surveys capturing the information are stopped amid a Trump administration purge.

  • April 01, 2025

    IBM And J&J Beat 'Speculative' Data Breach Suit, For Now

    A New York federal judge has tossed with leave to amend a proposed class action alleging IBM and Johnson & Johnson's healthcare arm failed to safeguard sensitive health information of thousands of patients before a 2023 data breach, finding the purported harm is "entirely speculative" as currently alleged.

  • March 31, 2025

    Texas Judge Deems Lab-Test Rule Outside FDA Authority

    A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."

  • March 31, 2025

    Buyer Class Of Surgical Robots Is Certified In Antitrust Fight

    A California federal judge on Monday certified a class of thousands of hospitals alleging Intuitive Surgical monopolized the market for robotic surgical tools by blocking third-party repairs and tying services to robot purchases, finding the case raises common antitrust questions that can be resolved on a classwide basis.

  • March 31, 2025

    FTC Chair Flags Data Risks In 23andMe Bankruptcy

    The Federal Trade Commission has added to the swell of privacy and security concerns surrounding the potential sale of sensitive consumer information swept up in the 23andMe bankruptcy, with the agency's Republican chair on Monday stressing the importance of data continuing to be protected in the way that users have been promised. 

  • March 27, 2025

    Meet The Attys Helping 23AndMe Through Ch. 11

    DNA testing company 23andMe Holding Co. enlisted a group of attorneys from Carmody MacDonald PC and Paul Weiss Rifkind Wharton & Garrison LLP to help it address $214 million in debt as it tries to sell its business through Chapter 11.

Expert Analysis

  • Privacy Lessons From FTC's BetterHelp Consent Decree

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    The Federal Trade Commission's recent enforcement action against BetterHelp highlights the growing risk associated with the use of third-party cookies and pixels on websites for companies that offer health services, say Rachel Marmor and Shannon Hartsfield at Holland & Knight.

  • 118th Congress: Investigative Priorities And Rule Changes

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    Attorneys at Gibson Dunn lay out what companies and individuals can expect with regard to congressional investigations in the 118th Congress, from political priorities to new rules and authorities.

  • Emerging Trends In Electronic Health Record Enforcement

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    As electronic health record systems become increasingly ubiquitous in health care, recent Anti-Kickback Statute and False Claims Act cases involving EHR systems provide a helpful list of issues that tech-savvy relators and government investigators might identify, say Ellen London at London & Stout and former Assistant U.S. Attorney Li Yu.

  • FTC's GoodRx Action Highlights Risks For Digital Health Cos.

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    The Federal Trade Commission's first-of-its-kind enforcement action against GoodRx for unlawfully sharing sensitive customer information is indicative of regulators' growing interest in the digital health space and heightens the importance of taking proactive compliance steps, say attorneys at Ropes & Gray.

  • What DOJ's 2022 Recovery Stats Say About FCA Enforcement

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    Despite showing a decline in False Claims Act recoveries in fiscal year 2022, the U.S. Department of Justice's recently released statistics should lead companies to expect a continued rise in government-initiated investigations, pandemic-related fraud enforcement and FCA cases involving new technology, say attorneys at Crowell & Moring.

  • Medicare Developments Ahead For Remote Health Monitoring

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    Stakeholders interested in remote monitoring services should keep an eye on an upcoming multijurisdictional contractor advisory committee meeting that may lead to a new local coverage determination affecting Medicare coverage for remote monitoring devices, say attorneys at McDermott.

  • Calif. Privacy Law Holds Implications For Mental Health Apps

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    California is leading the way in privacy regulation with its amended Confidentiality of Medical Information Act, which has important compliance repercussions for mental health app developers and could serve as a model for similar laws in other states, say Christine Moundas and Elana Bengualid at Ropes & Gray.

  • New Clinical Trial Law Promotes Diversity And Modernization

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    The Food and Drug Omnibus Reform Act, signed into law last month, will likely encourage more equitable subject recruitment and enrollment in clinical trials, and also could create a pathway toward clarifying ambiguities that have historically been left for regulated entities to piece together, say attorneys at Ropes & Gray.

  • Evaluating The Legal Ethics Of A ChatGPT-Authored Motion

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    Aimee Furness and Sam Mallick at Haynes Boone asked ChatGPT to draft a motion to dismiss, and then scrutinized the resulting work product in light of attorneys' ethical and professional responsibility obligations.

  • 2022 Law And Policy Highlights In Digital Health Care

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    This year, federal regulators made good on several commitments to create new opportunities for digital health innovators, and a number of promising cybersecurity bills are on the horizon, but not all virtual health care law and policy developments have been positive, say attorneys at Arnold & Porter.

  • Next Compliance Steps For Health Cos. Using Tracking Tech

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    In light of the U.S. Department of Health and Human Services Office for Civil Rights' expansive view of what constitutes protected health information, regulated entities seeking to provide websites and mobile apps for patients may need to choose between several imperfect compliance pathways if they wish to continue using tracking technologies, say attorneys at Ropes & Gray.

  • Top Trends And Challenges For Health Care Financing In 2022

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    Rising inflation, interest hikes, supply chain issues and public market disruption are just some of the factors that made 2022 a challenging year for financing health care deals, and all indications point to continued headwinds next year, say Stephanie McCann and Samantha Koplik at McDermott.

  • 2022 Data Privacy Suits Tested New Liability Theories

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    In the absence of a comprehensive federal data privacy law, plaintiffs lawyers are testing new theories of liability under state laws, and a look at recent lawsuits against online companies that have resulted in large settlements shows these attempts are more frequently being met with success, say attorneys at Quinn Emanuel.