Digital Health & Technology

  • April 09, 2024

    Philips, Feds Enter Consent Decree Over Sleep Apnea Devices

    Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.

  • April 09, 2024

    Predatory Medicare Marketing Faces Regulator Pushback

    Consumers weighing Medicare plan options should have greater protections from predatory marketing and sales tactics, thanks to a new rule by the Centers for Medicare & Medicaid Services that was finalized April 4.

  • April 08, 2024

    Doctors Say MSU Vax Mandate Suit Needs High Court Review

    Three doctors urged the U.S. Supreme Court to take up a case challenging Michigan State University's vaccine mandate after the Sixth Circuit backed the suit's dismissal, arguing that the circuit court should have applied a stricter standard when considering whether the government could interfere with patients' medical decisions.

  • April 04, 2024

    5th Circ. Scrutinizes Data-Tracking On La. Health Provider Site

    A Fifth Circuit panel questioned Louisiana health care providers Thursday on the use of "tracking pixels" on their website, asking counsel for the providers whether a third party like Facebook could access patient records without patient permission.

  • April 04, 2024

    Microsoft Unit Gets Fed. Circ. Alice Win On Imaging Patents

    The Federal Circuit on Thursday gave a win to a software company acquired by Microsoft for nearly $20 billion, affirming a decision that claims in four medical imaging patents it was accused of infringing are invalid for claiming only an abstract idea.

  • April 04, 2024

    Ga. OB-GYN Office Hit With Data Breach Class Action

    An Atlanta OB-GYN practice has been hit with a class action in Georgia federal court over a January data breach that allegedly impacted the personal and protected health information of tens of thousands of patients.

  • April 03, 2024

    Microsoft Notches Fed. Circ. Win In 3D Imaging Patent Fight

    The Federal Circuit on Wednesday backed a ruling from an administrative tribunal that wiped out most of a patent issued to a Florida radiologist and his ex-Lockheed Martin business partner, whose company is suing Microsoft over its line of HoloLens AR headsets.

  • April 02, 2024

    Mind Your Business: Wash. Privacy Law Ignites National Prep

    Companies far beyond the borders of Washington are taking stock of what customer data they're collecting — and what it might reveal — as they face compliance with the state's expansive new privacy law.

  • April 02, 2024

    Healthcare Deals This Week: Moderna, Hildred And More

    From a private equity fundraise worth hundreds of millions of dollars to a new life sciences IPO, the healthcare industry saw a handful of news-making deals this past week.

  • April 02, 2024

    Ga. Children's Hospital Accused Of Mining Patient Data

    A major Georgia pediatric healthcare system has been using web data trackers to illegally transmit confidential patient data to Facebook and other companies to boost its bottom line, according to a proposed class action filed in the Peach State on Tuesday.

  • March 29, 2024

    4th Circ. Revives Data Breach Suit Against Medical Center

    The Fourth Circuit on Friday revived a proposed class action alleging that Sandhills Medical Foundation Inc. failed to protect the personal information of patients whose data was leaked following a cyberattack, saying the health care provider is not shielded under federal immunity and that the government cannot be substituted as a defendant.

  • March 28, 2024

    White House Directs Agencies To Install AI Risk Safeguards

    The White House on Thursday issued a new directive requiring all federal agencies to address safety and civil rights risks in their use and procurement of artificial intelligence in an array of settings, including conducting screenings at airports and making decisions affecting Americans' healthcare, employment and housing.

  • March 26, 2024

    Meet The Calif. Atty Taking On Health Insurers' Use Of AI

    With the health insurance industry under scrutiny over its use of algorithms and artificial intelligence in the patient coverage review process, California appellate attorney Glenn Danas saw an opening for litigation with what he calls a "high outrage factor."

  • March 26, 2024

    Healthcare Hack May Be Wake-Up Call For Industry And Gov't

    The recent cyberattack that sabotaged vital billing and prescribing services operated by a UnitedHealth unit that processes roughly half the medical claims in the U.S. has highlighted the urgent need for providers in this critical sector to not only understand supply chain security risks, but also to work more closely with the federal government to combat these threats.

  • March 25, 2024

    Ga. Judge Slams Attys Over 'Incredible' House Arrest Request

    A Georgia federal judge on Monday postponed the sentencing of a cybersecurity contractor convicted of hacking into a hospital's computer systems after tearing into his attorneys over their request for nearly five years of home confinement instead of prison, for which the judge found "no basis."

  • March 22, 2024

    $900M Trade Secrets Case Against Kaiser Foundation Flops

    A California state judge has ruled that, after more than five years of litigation against the Kaiser Foundation, a pastor's small medical technology startup cannot "explain what was unique or secret about its conception for transmitting patient data" that was purportedly worth beyond $900 million.

  • March 22, 2024

    Final OK Sought For Economic Loss Deal In CPAP Recall MDL

    Users of Philips' recalled CPAP breathing machines have asked a Pennsylvania federal judge to give her final OK to their $467.5 million settlement with the company to cover economic loss claims, arguing only a few objections to the deal remain.

  • March 22, 2024

    LifeCell Cleared Of Liability In NJ Strattice Hernia Mesh Trial

    New Jersey state jurors on Friday cleared LifeCell of liability in a Kentucky woman's suit alleging the design of its Strattice surgical mesh is defective and caused a hernia to reoccur and ultimately resulted in "life-altering" surgery, giving the medical device company the first win in a venue with at least 93 pending cases with tort claims over the mesh.

  • March 21, 2024

    Colo. Distributor Seeks $2.3M Sanction For Stryker Spoilation

    A Colorado medical device distributor urged a federal judge to make Stryker and its lawyers pay $2.3 million in attorney fees as sanctions for "pervasive misconduct" throughout discovery and trial, arguing discovery violations will otherwise become the "cost of doing business" for the medical technology giant.

  • March 21, 2024

    UpHealth Claims $110M Win In Glocal Control Fight

    Global digital health company UpHealth Inc. says an arbitral panel has awarded it more than $110 million following a dispute that arose out of its subsidiary's acquisition of Glocal Healthcare Systems in 2020 — even as Glocal decried the award as "one-sided and perverse."

  • March 21, 2024

    Woman Lost Independence Due To Strattice Mesh, Jurors Told

    A Kentucky woman told New Jersey state jurors on Thursday that LifeCell skipped important safety steps while designing its Strattice surgical mesh, and that those skipped steps caused a hernia to reoccur and ultimately resulted in the loss of her independence.

  • March 21, 2024

    Fed. Circ. Upholds Edwards' PTAB Win On Heart Valve Patent

    The Federal Circuit has affirmed a Patent Trial and Appeal Board finding that various parts of medical technology maker Cardiovalve's patent on an artificial heart valve implant were invalid as obvious.

  • March 18, 2024

    Texas Hospital Loses Bid To Dismiss Patients' Hack Suit

    A Texas federal judge handed a win to the plaintiffs suing a hospital system in the aftermath of a hack that saw hundreds of patients' data pilfered, dismissing some of the claims in the proposed class action but allowing the suit to move forward after a hearing Monday.

  • March 14, 2024

    Health Co. Says Future Harm Risk Falls Short In Breach Suit

    New Jersey healthcare provider Capital Health System urged a Garden State federal judge on Wednesday to toss a proposed class action seeking damages as a result of a 2023 data breach, arguing that the plaintiffs failed to allege their personal identifying information was actually misused.

  • March 13, 2024

    HHS To Investigate Whether Cyberattack Exposed Patient Data

    The U.S. Department of Health and Human Services opened an investigation Wednesday into the cyberattack on Change Healthcare to determine whether the hack exposed patients' confidential data or violated other privacy protections.

Expert Analysis

  • How SEC And NY Cyber Reporting Rules Affect Key Industries

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    The new U.S. Securities and Exchange Commission and New York State Department of Financial Services cybersecurity disclosure requirements, and their competing obligations, reveal the increasing complexity for organizations evaluating and reacting to cybersecurity incidents — particularly those in the healthcare and financial services industries, say attorneys at Manatt.

  • In The World Of Legal Ethics, 10 Trends To Note From 2023

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    Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.

  • 5 Steps For Healthcare Companies After Biden's AI Order

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    Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.

  • The Basics Of Law Firm Cyber Liability Insurance Applications

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    Cyber liability insurance has become a common consideration for law firms as cyber threats have escalated, but these insurance forms can be quite complicated given the nature of the industry and associated risks, so simply filling out the form won't necessarily result in an ideal policy for your firm, says Kevin Haight at WAMS.

  • AI Brings New Insurance Concerns For Healthcare Providers

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    As the healthcare industry increasingly invests in medical artificial intelligence tools, it confronts a variety of liability risks that necessitate careful consideration and potential recalibration of providers' insurance programs, say Marialuisa Gallozzi and Megan Mumford Myers at Covington.

  • Writing Thriller Novels Makes Me A Better Lawyer

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    Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.

  • White House Activity Is A Band-Aid For Regulating AI In Health

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    In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.

  • How Legal Teams Can Prep For Life Sciences' Tech Revolution

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    The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.

  • General Counsel Need Data Literacy To Keep Up With AI

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    With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.

  • Life Sciences Regulators Must Write Cloud-Specific Guidance

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    As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.

  • 3 Tips For Defending Against Data Breach Litigation

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    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.

  • What Pharma Cos. Must Know About FDA Off-Label Guidance

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    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.

  • It's Time To Prescribe Frameworks For AI-Driven Health Care

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    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.