Digital Health & Technology

  • April 22, 2024

    Watchdog Nixes Unfair Treatment Claims In $310M VA IT Deal

    The U.S. Government Accountability Office was unconvinced that the U.S. Department of Veterans Affair graded an IT firm's bid for a $310.3 million deal more harshly than a competitor's, saying the rankings reflected differences in the bids.

  • April 19, 2024

    Edelson Pitches 'Better Way' To Pick Leads In Privacy Suits

    Plaintiffs in proposed privacy class actions should be given more say in who's picked as class counsel, in order to crack down on the "anemic settlements" that have resulted from the ineffective "old way of litigating" these matters, law firm Edelson PC argued in vying for lead counsel in a dispute over a data breach at genetics testing provider 23andMe.

  • April 19, 2024

    AI Health Data Co. Faces Investor Suit Over Accounting Issues

    Atlanta-based health data platform company Sharecare and two of its executives face accusations that they failed to disclose certain accounting issues to investors, leading to stock price declines when the issues became public, according to a shareholder suit filed Friday in California federal court.

  • April 19, 2024

    Northshore Health Worker Drops Genetic Info Privacy Claims

    A patient sitter for Northwestern HealthSystem has voluntarily dropped her proposed class suit claiming she and other workers were unlawfully required to give up information about their medical histories during the application process.

  • April 18, 2024

    Patient Data Breach Suit Should Be Tossed, Colo. Judge Says

    A judge has recommended that CommonSpirit Health be allowed to escape a proposed class action in Colorado federal court accusing it of failing to secure healthcare data leading to a breach affecting more than 600,000 patients, saying the complaint fails to "allege an injury-in-fact."

  • April 16, 2024

    House Panel Takes Aim At Change Healthcare, FTC Over Hack

    A House subcommittee exploring ways to boost cybersecurity in the healthcare industry on Tuesday blasted Change Healthcare for failing to take appropriate steps to block a damaging cyberattack that echoed another recent strike on critical infrastructure and the Federal Trade Commission for not stopping the provider from controlling such a large market share. 

  • April 16, 2024

    Healthcare Industry Sees Spate Of New Data Sharing Suits

    A $7 million-plus settlement between a federal regulator and a mental healthcare provider accused of improperly sharing patient data highlights the ubiquitous ties between health systems and tech giants like Facebook — and the growing legal and regulatory scrutiny over those relationships.

  • April 12, 2024

    Zoll Says 'Cookie-Cutter' Hack Claims Don't Show Harm

    Zoll Medical Corp. is asking a Boston federal judge to toss a proposed class action brought by medical device customers whose personal information was released during a ransomware attack last year and an earlier data breach in 2019, arguing the consumers weren't actually injured.

  • April 11, 2024

    FTC Curtails Treatment Provider's Sharing Of Health Data

    The Federal Trade Commission took its latest step Thursday to crack down on the mishandling of sensitive health information, announcing a settlement that requires a New York-based alcohol addiction treatment service to obtain affirmative consent before sharing this data with third parties and bars the company from disclosing this information for advertising purposes.

  • April 11, 2024

    Ernest Health Hit With Suit After Cybercriminal Data Breach

    A group of former Ernest Health Inc. patients has hit the Texas-based hospital system with a proposed class action after a notorious group of cybercriminals breached the company's systems, saying that the company should've done more to protect patient data in a Thursday complaint.

  • April 10, 2024

    Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed

    A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.

  • 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.

Expert Analysis

  • 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.

  • FDA Proposals Clarify Rules For Devices With Predicates

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    As medical devices continue to grow in complexity, U.S. Food and Drug Administration policies surrounding premarket submissions for devices with existing predicates have fallen behind, but new draft guidances from the agency help fill in some gaps, say attorneys at Hogan Lovells.

  • How Int'l Regulatory Collabs Can Expedite Pharma Approvals

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    Recent announcements highlight the growing importance of international regulatory collaboration for drug approval, which can greatly streamline the process for companies seeking to market their drugs in other countries, say Geneviève Michaux and Christina Markus at King & Spalding.

  • Why Standing Analysis Is Key In Data Breach Mediation

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    Amid a growing wave of data breach class action litigation, recent legal developments show shifting criteria for Article III standing based on an increased risk of future identity theft, meaning parties must integrate assessments of standing into mediation discussions to substantiate their settlement demands in data breach class actions, says Abe Melamed at Signature Resolution.

  • 2 New Ways FDA Is Changing Lab-Developed Test Regulation

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    The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.

  • FDA's Lab-Developed Test Rule Faces High Hurdles

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    The U.S. Food and Drug Administration's recently announced plans to explicitly regulate lab-developed tests will likely face resistance from industry stakeholders and congressional actions, and lead to significant litigation, say attorneys at Hogan Lovells.

  • FDA's Drug Software Draft Guidance Raises New Questions

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    The U.S. Food and Drug Administration's long-awaited draft guidance regarding regulatory considerations for prescription drug use-related software functions as an informative starting point for developers, but many new and lingering questions must be answered before the regulatory limbo is resolved, say attorneys at King & Spalding.