Digital Health & Technology

  • 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.

  • February 01, 2024

    HHS OKs Telehealth, At-Home Flexibility For Opioid Treatment

    Federal authorities plan to permanently extend pandemic-era rules that allow patients in opioid treatment programs to take methadone at home and obtain prescriptions for buprenorphine during telehealth visits, as part of an effort to combat opioid addiction.

  • January 31, 2024

    FDA Has More Cyber Guidance Planned For Device Makers

    A U.S. Food and Drug Administration official said Wednesday that further guidance is likely in store in 2024 as the agency marks its first year with the new authority to require device makers to submit cybersecurity compliance plans with applications to bring new healthcare devices to market.

  • January 31, 2024

    FDA May Have To Cut Activities As Need to Regulate AI Grows

    The U.S. Food and Drug Administration may have to pare back functions if Congress doesn't grant it the budget increase it has requested while the agency tries to keep up with rapid developments in the use of artificial intelligence in healthcare.

  • January 31, 2024

    FDA, Health Experts Talk Int'l 'Harmonization' of AI Regulation

    Cross-border compatibility of rules for artificial intelligence-powered medical devices is critical for device makers looking to globalize their products in an evolving regulatory landscape, legal and governmental experts said Wednesday.

  • January 31, 2024

    Northwell Health Sued Over Breach Of 3M Patients' Data

    Northwell Health Inc., New York state's largest health care system, breached its duty to protect sensitive information by failing to keep safe the data of over 3 million individuals in a breach, according to a proposed class action filed Tuesday.

  • January 31, 2024

    Teladoc Illegally Sends Users' Personal Info To Meta, Suit Says

    Teladoc users have filed a putative class action in New York federal court accusing the virtual healthcare giant of privacy invasion for allegedly using a tracking pixel on its website to secretly wiretap their communications and activities, then subsequently sharing their personal information with Facebook without their permission.

Expert Analysis

  • 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.

  • Tips For In-House Legal Leaders In A Challenging Economy

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    Amid today's economic and geopolitical uncertainty, in-house legal teams are running lean and facing increased scrutiny and unique issues, but can step up and find innovative ways to manage outcomes and capitalize on good business opportunities, says Tim Parilla at LinkSquares.

  • Health Providers Must Beware FCA Risks When Using AI

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    Though recent innovations in artificial intelligence can potentially bring increased productivity, greater efficiency and reduced costs to the healthcare industry, providers must take appropriate precautions to avoid risks and potential False Claims Act liability, says Sara Lord at Arnall Golden.

  • New Considerations In Med Device Cybersecurity Compliance

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    Recent guidance from the U.S. Food and Drug Administration clarifies premarket submission procedures related to medical device cybersecurity, and indicates a significant expansion in the agency's expectations surrounding risk management practices for both manufacturers and providers, says Meghna Parikh at Buchalter.

  • Federal Oversight Of AI In Healthcare Is Taking Shape

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    A recent proposed rule from the U.S. Department of Health and Human Services provides early insights into how the federal government intends to oversee artificial intelligence and machine learning in healthcare, highlighting priorities like transparency, equity and potential kickback implications, say attorneys at Hooper Lundy.

  • A Close Look At Pennsylvania's Data Breach Law Changes

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    New amendments to Pennsylvania's Breach of Personal Information Notification Act will hold state agencies to stricter notification requirements more in line with those in other states, and will allow entities to determine a breach has occurred before their notification obligations take effect, says Lauren Godfrey at Constangy.

  • Abortion Pill Rulings Will Hinder FDA Authority

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    Although the Fifth Circuit recently stayed a Texas federal court's ruling that invalidated the U.S. Food and Drug Administration's approval of a commonly used abortion medication, several points made by the courts are worth considering for their potentially chilling effect on FDA authority and the challenges they may create for the life sciences industry, say attorneys at Morgan Lewis.

  • Key Guidelines For Conducting Clinical Trials Overseas

    Excerpt from Practical Guidance
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    Conducting clinical trials outside the U.S. offers many benefits to researchers, but these benefits come with countervailing ethical and legal challenges that must be carefully addressed, say attorneys at Bass Berry.

  • Recent Growth Factors Driving Life Sciences Transactions

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    In view of challenges posed by last year's economic downturn, life sciences companies have increasingly turned to collaboration and licensing arrangements, with a focus on deal activity in artificial intelligence, digital health and gene therapy, say attorneys at Ropes & Gray.

  • How Cannabis Cos. Can Keep Up With Privacy Compliance

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    With the cannabis industry's rapid growth and access to sensitive consumer information, and the ever-changing patchwork of state data privacy laws, it is becoming increasingly important for marijuana businesses to treat cybersecurity as a significant risk and management priority, say attorneys at Goodwin.