Digital Health & Technology

  • February 12, 2024

    FDA Seeks Comment On Guidance For Clinical Trial Sponsors

    The U.S. Food and Drug Administration is set to publish draft guidance on Tuesday that aims to help clinical trial sponsors determine when they need to bring in a group of data experts to review the information being collected in a clinical trial. 

  • February 09, 2024

    Healthcare Cybersecurity Bill Puts Focus On HHS Oversight

    Members of a U.S. Senate cybersecurity commission introduced a bill Friday that would require federal health officials to conduct regular evaluations of digital security systems and issue biennial reports to Congress.

  • February 09, 2024

    Mental Health App Says Former Exec Can't Lead Rival

    Therapy app company SonderMind Inc. has filed a lawsuit in Denver state court alleging a former chief medical officer is violating a non-compete clause he signed by taking an identical role at rival company Rula Health.

  • February 09, 2024

    HHS Establishes Rule For Release Of Substance Use Records

    Records of a patient's substance use treatment may be more easily shared among healthcare providers under a massive new rule issued by the U.S. Department of Health and Human Services, a step the agency said will help coordinate and improve patient care.

  • February 09, 2024

    23andMe Led To Late Father And $28M Verdict, Woman Says

    A Massachusetts woman's successful quest to learn her father's identity through the ancestry-tracking company 23andMe took a surprising turn when she later learned her new flesh-and-blood relatives left her out of her father's wrongful death suit that resulted in a $28 million jury verdict, according to a state court lawsuit.

  • February 08, 2024

    AI Shouldn't Stay In 'Ivory Tower,' Health Experts Tell Sens.

    U.S. Senators on Thursday heard from experts from Stanford University and other institutions on how to ensure that healthcare benefits promised by artificial intelligence, from improved patient outcomes to lower costs, do not remain confined to the "ivory tower" but instead reach underresourced hospitals.

  • February 08, 2024

    Broker Hit With Suit Over Data Breach Affecting 1.5 Million

    A California insurance broker is facing a proposed class action filed Thursday in federal court accusing the company of failing to keep the health and personal information of more than 1.5 million customers safe from exposure in an August cyberattack.

  • February 08, 2024

    Conn. Doc Says Website Must Unmask Fake Online Reviewer

    A Connecticut plastic surgeon asked a state court Wednesday to force the operator of website HealthGrades.com to unmask the person who posted an allegedly fake review saying she was "disfigured" by a recent procedure.

  • February 07, 2024

    US Tells 9th Circ. Stem Cell Clinic Not Exempt From FDA Rules

    The federal government urged a Ninth Circuit panel Wednesday to revive its bid to stop a clinic from offering experimental stem cell treatments, arguing the clinic's procedures are governed by the Food, Drug and Cosmetic Act because they result in a new product that is marketed as a cure for certain diseases. 

  • February 07, 2024

    Existing Laws May Stymie AI Potential To Improve Healthcare

    Medical liability and privacy laws already in place may stall the use of artificial intelligence tools to improve healthcare delivery, a bioethics and health law expert said Wednesday.

  • February 07, 2024

    Surgical Robot Co. Sued Over Internal Burns, Death Of Patient

    A widower is suing Intuitive Surgical Inc. in Florida federal court, alleging the company hid a defect in its da Vinci surgical robots that allowed electricity to arc during his wife's surgery, burning her small intestine and leading to her death.

  • February 06, 2024

    HHS Signs $4.75M Pact With NYC Hospital Over Data Theft

    A hospital in New York City's borough of the Bronx has agreed to pay $4.75 million and implement a corrective active plan to resolve the U.S. Department of Health and Human Services' claims that Montefiore Medical Center's "multiple" potential data security failings led to an employee stealing and selling thousands of patients' protected health information, the HHS said Tuesday. 

  • February 06, 2024

    10th Circ. Affirms $4.7M Stryker Loss, But Tosses Fee Award

    A Tenth Circuit panel said on Tuesday that medical device maker Stryker is not required to indemnify a Colorado distributor for the cost of winning a lawsuit against it, according to a ruling that upheld a $4.7 million judgment against Stryker but vacated a $2.3 million fee award.

  • February 06, 2024

    Medical Device Co. Accuses Ex-Sales Reps Of Stealing Clients

    Two sales representatives broke noncompete and confidentiality agreements when they "conspired to steal" more than $1 million worth of business from their then-employer before leaving for a competitor, a medical device company alleged in a suit filed Monday in Texas federal court.

  • February 06, 2024

    Attys Seek $750K Fee In Del. For $6M Med Tech Co. Deal

    Proposed class attorneys who secured a $6 million settlement from medical device company AMDI Inc. after a purportedly underpriced and conflicted stock sale to an interest of Oracle founder Larry Ellison have asked Delaware's Chancery Court to approve $750,000 in attorney fees for their work.

  • February 06, 2024

    AI Operating System Built For Healthcare Lands $70M

    San Francisco-based Ambience Healthcare, a generative AI technology startup targeting the medical world, has raised $70 million in Series B funding, the company announced Tuesday.

  • February 05, 2024

    Kochava Can't Shake FTC's Location Data Privacy Suit

    An Idaho federal judge has refused to ax the Federal Trade Commission's suit accusing mobile app analytics provider Kochava Inc. of unlawfully selling precise geolocation data, finding that the expanded consumer harm allegations that the agency put forth in its revised complaint were sufficient to allow the dispute to move forward. 

  • February 05, 2024

    Colo. Software Co. Won't Release Patient Data, Practice Says

    A Connecticut-based fertility practice has alleged in Colorado state court that a Denver software vendor has held its patients' records hostage since the two companies mutually agreed to end their business relationship nearly a year ago.

  • February 02, 2024

    ACLU Atty On How To Protect Civil Liberties In The AI Era

    Because artificial intelligence and algorithmic systems often operate in the shadows, there's a new need for legislation, regulation and enforcement to ensure the technology doesn't undercut civil liberties by engaging in discrimination in housing, education or employment, according to Cody Venzke, senior policy counsel for the American Civil Liberties Union.

  • February 02, 2024

    Ascension Says Medical Queries Don't Breach Genetic Privacy

    Questions about family medical history raised during a hospital job interview don't implicate an Illinois genetic privacy law, healthcare giant Ascension Health has told a Missouri federal court.

  • February 02, 2024

    Groups Urge Probe Into Deloitte's Medicaid Eligibility System

    A group of public interest organizations is accusing Deloitte of developing a problematic Medicaid eligibility system that's left beneficiaries in Texas without healthcare coverage, and has asked the Federal Trade Commission to investigate. 

  • February 01, 2024

    DOJ Looking For Privacy Perils In Digital Healthcare

    Threats to data privacy and fraud in telemedicine are among federal regulators' top concerns in evaluations of digital healthcare as innovation invites new challenges to protecting patient data and preventing fraud, a U.S. Department of Justice official said Thursday.

  • February 01, 2024

    Device-Maker Attys Talk FDA Nondevice Rule At Conference

    Over a year after the FDA issued its Clinical Decision Support Software guidance for nonmedical devices that describes the agency's approach to medical device software functions, attorneys working in the medical device regulation space are still grappling with the guidance and learning how the FDA is enforcing the regulation.

  • February 01, 2024

    FTC Puts Cap On Blackbaud's Data Retention In Breach Deal

    Blackbaud Inc. has agreed to delete personal data that it doesn't need anymore and boost its data security to resolve the Federal Trade Commission's claims over a 2020 ransomware attack that affected millions of consumers, the commission announced Thursday, marking the latest regulatory action the software provider has settled over the data breach. 

  • February 01, 2024

    Drug Cos. Not Ready for 'Deep End' of Remote Trials

    Enthusiasm among drug companies and federal officials about increasing diversity among clinical subjects through "decentralized" trials is being tempered by unknowns about the regulatory landscape, a group of experts said Thursday.

Expert Analysis

  • 5 Data Privacy Practices Cos. Should Implement Now

    Author Photo

    Businesses that are not subject to a comprehensive data privacy law should nevertheless consider implementing privacy practices that are consistent with current norms to help mitigate both common law exposure and an expensive rush to compliance if a federal law is passed, say John Rolecki and Alexander Thibodeau at Varnum.

  • Privacy Lessons From FTC's BetterHelp Consent Decree

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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.

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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.