Digital Health & Technology

  • January 23, 2024

    Australia, US, UK Sanction Russian Over Medibank Hack

    Officials from Australia, the U.S. and the United Kingdom revealed Tuesday that they had sanctioned a Russian national believed to have played an integral role in a 2022 cyberattack that hit Australian health insurer Medibank Private Ltd., marking the first time the three nations have made such a coordinated strike. 

  • January 23, 2024

    FDA Pilot Program Accepts First AI Health Technology

    An automated depression and anxiety severity measurement tool is the first artificial intelligence-based and digital health technology-based project as well as the first neuroscience project accepted into the U.S. Food and Drug Administration's Innovative Science and Technology Approaches for New Drugs Pilot Program, or ISTAND, the agency announced Tuesday.

  • January 22, 2024

    NY Senate Backs Bill Bolstering Healthcare Data Privacy

    New York state's Senate on Monday signed off on legislation that would require companies collecting and selling healthcare information to have user consent before selling that data to third parties, passing a bill that's part of a legislative package lawmakers say is aimed at "reproductive equity."

  • January 22, 2024

    Anna Jaques Hospital Sued In Mass. Over Hacked Patient Data

    Anna Jaques Hospital was hit with a proposed class action on Monday in Massachusetts state court alleging the hospital failed to maintain adequate cybersecurity measures, leading to a December breach potentially involving thousands of patient records.

  • January 22, 2024

    4th Circ. Preview: Timberland's TM Bid Kicks Off 2024

    The Fourth Circuit will kick off 2024 by probing Timberland's bid to trademark its footwear and pondering an embattled insurance mogul's attempt to escape a $524 million judgment.

  • January 22, 2024

    Boston Biopharma Co. Picks Industry Veteran As Next GC

    Biopharma company BPGbio Inc. announced Monday the appointment of a compliance specialist and former Cooley LLP associate as its new general counsel.

  • January 19, 2024

    Law360 Names Firms Of The Year

    Eight law firms have earned spots as Law360's Firms of the Year, with 55 Practice Group of the Year awards among them, steering some of the largest deals of 2023 and securing high-profile litigation wins, including at the U.S. Supreme Court.

  • January 19, 2024

    Law360 Names Practice Groups Of The Year

    Law360 would like to congratulate the winners of its Practice Groups of the Year awards for 2023, which honor the attorney teams behind litigation wins and major deals that resonated throughout the legal industry this past year.

  • January 19, 2024

    Lawmakers Urge HHS To Make Telehealth Policy Permanent

    A bipartisan group of senators and representatives on Friday pressed the U.S. Department of Health and Human Services to make permanent the temporary pandemic-era expansions in Medicare telehealth coverage before the end of the year.

  • January 19, 2024

    Colo. Group Seeks Damage Caps Drop, Reporting Expansion

    An issue committee, supported in part by the Colorado Trial Lawyers Association, has launched an effort to place two statewide initiatives before Colorado voters in November, designed to help patients and those filing suits over catastrophic injuries and wrongful deaths.

  • January 19, 2024

    Becton Investors Get Initial OK Of $85M Deal Over Recall

    A magistrate judge granted preliminary approval to an $85 million settlement a class of Becton Dickinson investors reached with the medical tech company over securities fraud claims that it hid regulatory problems regarding sales of its Alaris infusion pump, which Becton recalled in 2020.

  • January 19, 2024

    WHO Report Examines Pros And Cons Of AI In Healthcare

    The World Health Organization has released new guidance on opportunities and ethical risks presented by introducing generative artificial intelligence models such as ChatGPT into the healthcare sector.

  • January 19, 2024

    Fla. Medical Device Co. Sued Over Data Breach That Hit 54,000

    A Tampa-based medical device company has been sued over a data breach that allegedly compromised the personal information of 54,000 people, with a proposed federal class action alleging that the company was negligent in protecting its customers' private data.

  • January 18, 2024

    FTC Asked To Force Google To Delete Sensitive Location Data

    Google hasn't kept its promise to delete sensitive location data, including records of users' visits to abortion clinics and addiction centers, a pair of tech advocacy groups told the Federal Trade Commission on Thursday, urging the commission to hit Google with penalties and block its "unlawful" data practices.

  • January 18, 2024

    CMS Announces State-Based Behavioral Health Model

    The Centers for Medicare & Medicaid Services on Thursday launched a program it said will fund up to eight states to implement a new value-based care model designed to improve health outcomes for vulnerable populations.

  • January 18, 2024

    FDA And CMS Leaders Unite Over Proposed Lab Test Rule

    Leaders at the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services joined forces on Thursday, stressing that the two agencies are on the same page regarding the FDA providing increased oversight of laboratory developed tests, or LDTs.

  • January 18, 2024

    Midwest Healthcare Group Escapes Bulk Of Data Breach Suit

    An Illinois federal judge tossed most of a proposed class action alleging an anti-poverty nonprofit's careless management of clients' personal information, including sensitive health information, resulted in a data breach.

  • January 17, 2024

    Apple Drops Blood Oxygen Tech From New Watches After Ban

    After the Federal Circuit ruled Wednesday that Apple can't import Apple Watches that include a blood oxygen sensor found to infringe two Masimo patents, Apple said the feature will be dropped from its flagship watch models sold beginning Thursday.

  • January 16, 2024

    Hospital Groups Nationwide Slam Online Tracking Restrictions

    Federal guidance restricting the use of online tracking technology in healthcare has disrupted the ability of hospitals to reach underserved communities and connect the public with accurate medical information, 17 state hospital associations told a federal court.

  • January 16, 2024

    Crowell Adds Moses Singer Health Trio In New NYC Office

    Crowell & Moring LLP announced Tuesday that it has hired a team from Moses & Singer LLP with rare expertise in regulatory and compliance issues related to clinical trials for biotech and health tech companies.

  • January 15, 2024

    Apple Cleared To Avoid Import Ban With Redesigned Watch

    U.S. Customs and Border Protection has found that redesigned versions of the Apple Watch without a blood oxygen monitor are not subject to an import ban in a patent dispute with Masimo, according to a Monday court filing by Masimo.

  • January 12, 2024

    Healthcare Co. HealthEC Hit With Data Breach Suit

    Healthcare software company HealthEC has been hit with a lawsuit alleging that a July 2023 data breach affected nearly 4.5 million patients and that the company failed to comply with Federal Trade Commission guidelines and industry standards.

  • January 12, 2024

    Lab Says COVID-19 Test-Maker Owes $30M Over Faulty Kits

    A California-based manufacturer of COVID-19 testing kits has been hit with a $30 million suit alleging it sent defective tests to an independent clinical lab, causing the lab to receive false positive results and subsequently get banned from testing sites.

  • January 11, 2024

    Quest Fertility Biz Reaches $1.25M Deal In Data Breach Case

    A Quest Diagnostics fertility treatment unit has reached a $1.25 million settlement, according to a Wednesday filing in Massachusetts federal court, after a 2021 ransomware attack and accusations that a slow response by Quest left sensitive information unguarded.

  • January 11, 2024

    Electronic Waveform Says Travelers Owes It $1.3M

    A Minnesota medical device manufacturer has told a federal court that insurer Travelers has been intentionally down-coding a pain management device popular among professional athletes in order to underpay the company, resulting in a loss of $1.3 million.

Expert Analysis

  • How Contractors Can Avoid Cybersecurity FCA Violations

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    Recent U.S. Department of Justice settlements and remarks underscore heightened focus on cybersecurity liability under the False Claims Act, so government contractors should consider compliance measures such as conducting periodic risk assessments, being responsive to employee concerns, and more, say attorneys at WilmerHale.

  • EU Regulation Highlights AI Issues For Digital Health Cos.

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    As the regulation of artificial intelligence is high on the agenda for EU and U.K. policymakers and regulators, and likely imminent in the U.S., now is the time for providers in the digital health space to consider how compliance may need to change, and safeguard their position in the market, say Chris Eastham and Olivia Morgan at Fieldfisher.

  • What DOJ Enforcement Shift Means For Life Sciences Cos.

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    Though monitoring life science company compliance has historically been the domain of the U.S. Department of Health and Human Services, recent trends suggest that the U.S. Department of Justice may be assuming a primary role going forward, raising interesting questions for the industry, say attorneys at Skadden.

  • Ransomware Payment Lessons Amid DOJ Recovery Success

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    The U.S. Department of Justice’s recent successes clawing back ransom payments made to hacking groups provide companies an additional factor to consider when deciding whether to engage with law enforcement after experiencing a breach, whether to pay a ransom demand, and whether to try to recover the payment, says Tyler Bridegan at Wiley.

  • What's Next For DOJ's COVID Enforcement In Health Care

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    As we enter the end of the third year of the pandemic, a few fraud-related trends and risks have emerged, necessitating important steps that health care and life sciences companies should take in light of continuing U.S. Department of Justice scrutiny, say attorneys at Arnold & Porter.

  • How To Minimize Risk When Launching Smart Medical Devices

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    Prior to launching a smart medical device, there are several critical steps that companies can take in order to protect their intellectual property, get approval from the U.S. Food and Drug Administration and ensure the safety of their data, say attorneys at Crowell & Moring.

  • Health Issues To Watch In Inflation Act, Other Policy Initiatives

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    The newly signed Inflation Reduction Act includes a number of significant drug pricing reforms, and the future holds a wider array of health issues that may be addressed in pending legislation when Congress returns in September, says Miranda Franco at Holland & Knight.

  • DOJ Filing Reawakens Fraud-On-The-FDA Theory Of Liability

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    The U.S. Department of Justice’s recent statement of interest in U.S. ex rel. Crocano v. Trividia Health before a Florida federal court represents a substantial attempt to revive a False Claims Act liability theory involving misstatements to the U.S. Food and Drug Administration, potentially leading to increased scrutiny of medical products, say attorneys at Duane Morris.

  • Digital Health Cos. Should Expect More Scrutiny Amid Growth

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    As the digital health market continues to flourish, the privacy and security of patient data has become a focus of legislative, regulatory and interest group action, and developers should be motivated to reassure both regulators and consumers that users' data is adequately protected, say attorneys at Kirkland.

  • Anti-Kickback Circuit Split Holds Implications For Defendants

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    The Eighth Circuit's recent decision in U.S. v. D.S. Medical represents a significant step toward holding plaintiffs to more exacting burdens of proof in Anti-Kickback Statute False Claims Act suits, and the outcome of the resulting circuit split could decrease estimated damages for defendants, say attorneys at Gibson Dunn.

  • Post-Dobbs HHS Guidance Brings Privacy Considerations

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    The U.S. Supreme Court's recent decision in Dobbs v. Jackson Women's Health Organization, and ensuing guidance from the U.S. Department of Health and Human Services, will create new privacy compliance issues for health care providers and other companies collecting personal information concerning the use of reproductive health services, say attorneys at Ropes & Gray.

  • HHS Fraud Alert Is A Major Warning To Telehealth Industry

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    The U.S. Department of Health and Human Services recently issued a rare fraud alert, indicating potential changes in telemedicine enforcement, and suggesting that digital health entities are likely to face subpoenas, civil investigative demands and other inquiries, say attorneys at Hooper Lundy.

  • FDA Medical Device Cyber Guidance Protects Patients, Cos.

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    By carefully following the U.S. Food and Drug Administration regulations on cybersecurity for medical devices — including its latest guidance on premarket submissions — and anticipating, tracking and fixing vulnerabilities, manufacturers can reduce risks to patients, as well as their own risks of product liability and data breach claims, say attorneys at Dechert.