Digital Health & Technology

  • 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.

  • January 11, 2024

    FCC Issues Final Rule On Rural Telehealth Discount

    The Federal Communications Commission on Wednesday issued an update to the Rural Health Care program, changing it to allow healthcare providers with conditional eligibility to request funding and compete for bidding.

  • January 11, 2024

    Conn. Healthcare Co. Eyes Deal For Data Breach Class

    Merritt Healthcare Advisors is working to finalize a settlement with a proposed class of consumers who claim that the company's lax security allowed cybercriminals to access their personal information, according to a paperless order entered Thursday in the District of Connecticut.

  • January 10, 2024

    Rex Medical Asks Fed. Circ. To Decry Slashing Of $10M Award

    Rex Medical LP is asserting to the Federal Circuit that a Delaware federal judge was wrong to slash a jury's $10 million patent damages verdict in Rex's favor to just $1 over a purported lack of evidence.

  • January 10, 2024

    FDA 'Can't Do This Alone,' Wants Help Vetting AI In Healthcare

    The Food and Drug Administration will almost certainly need outside help regulating the safety of artificial intelligence deployed by hospitals and healthcare organizations, the agency's commissioner said Wednesday, citing the complexity of the technology and need to track health outcomes over long periods of time.

  • January 09, 2024

    FDA Digital Tech Rule Faces Health Privacy, Inequity Test

    A new federal road map for collecting "remote" health data in clinical investigations could help speed such technologies to the marketplace, experts told Law360, while creating new risks to patient privacy and the effort to address inequities in healthcare.

  • January 09, 2024

    FTC Halts Data Broker's Location Data Sharing In Novel Deal

    The Federal Trade Commission has stepped up its efforts to curtail the unauthorized disclosure of consumers' sensitive location information, announcing a groundbreaking settlement Tuesday with a data broker that the agency claims unlawfully sold precise location data that could be used to track people to reproductive health clinics, religious worship centers and other sensitive places.

  • January 09, 2024

    Mich. Resident Sues Software Co., Provider Over Data Breach

    A Michigan resident is asking a federal court to impose damages on software company Welltok LLC and Michigan provider Corewell Health East after the health information of a million patients in its database became the target of a ransomware attack.

  • January 08, 2024

    Orrick Client Delta Dental Of Calif. Hit With Data Breach Suit

    Weeks after Delta Dental of California's law firm Orrick Herrington & Sutcliffe LLP was hit with a proposed class action over a data leak that allegedly included Delta files, the insurer was hit with a suit in Massachusetts federal court on Monday over another leak connected to the massive MOVEit data breach.

  • January 08, 2024

    Wash. Pediatric Hospital Asks Judge To Toss Data Privacy Suit

    Seattle Children's Hospital has urged a state judge to dismiss a proposed class action alleging the hospital violated Washington privacy and consumer laws, contending the plaintiffs' own actions were to blame if any personal information was shared with Meta, the parent company of Facebook.

  • January 08, 2024

    Eli Lilly, Novartis Could Pump Close To $3B Into AI Drug Tech

    Eli Lilly & Co. and Novartis could invest close to $3 billion in the development of artificial intelligence for drug discovery under two new agreements with a digital biology company owned by Google's parent company.

  • January 05, 2024

    Hospitals Want Fast End To 'Flawed' Online Tracking Rules

    The American Hospital Association and others on Friday urged a Texas federal court to scrap federal guidance effectively barring certain healthcare entities from using online tracking technology as the data captured from visitors to their websites falls "far outside" the information protected by federal health privacy law. 

  • January 05, 2024

    Eli Lilly Goes Straight To Consumers With Telehealth Platform

    A new website launched by Eli Lilly & Co. will connect patients with doctors who treat obesity and offer direct home delivery of the company's obesity drug Zepbound, which the U.S. Food and Drug Administration approved in November.

  • January 05, 2024

    Split 9th Circ. Revives Antitrust Suit Against Catheter Maker

    A split Ninth Circuit panel sided with Innovative Health LLC on Friday and revived its antitrust suit against Biosense Webster Inc. in a dispute over the market for catheters, saying Innovative provided sufficient evidence to defeat summary judgment in its claim that Biosense tied the sale of catheters to clinical support services.

  • January 05, 2024

    Barley Snyder Promotes Health, Estate Attys To Partnership

    Barley Snyder has announced the addition of an experienced healthcare lawyer and an expert estate planner as its first new partners of the year.

  • January 05, 2024

    Ga. Board Restores Telehealth Rx For Controlled Substances

    A Georgia medical oversight group has relented and restored doctors' ability to prescribe controlled substances, including painkillers and attention-deficit medications, via virtual visits.

  • January 05, 2024

    IQVIA Drops Healthcare Ad Deal After Court Pause

    Healthcare data company IQVIA has abandoned its planned purchase of Propel Media after the Federal Trade Commission convinced a court to pause the deal over concerns about the cost of advertising that targets doctors and other healthcare professionals.

  • January 04, 2024

    Birth Control Clips Hurt Women When They Move, Suit Says

    The Filshie Clips birth control device may move around after implantation, a hazard the clips' manufacturers did not warn the public or healthcare professionals about, according to a Connecticut federal lawsuit from a woman who says she was injured by them.

  • January 04, 2024

    Merck And Insurers Settle $1.4B Cyberattack Coverage Case

    Merck has reached a settlement with its insurers over whether the pharmaceutical giant's "all-risk" property insurance covered $1.4 billion in losses stemming from the 2017 NotPetya attack or if its "hostile/warlike" exclusion applies.

  • January 03, 2024

    AHA Says Data-Blocking Penalty Threatens Rural Hospitals

    A proposed federal rule that establishes monetary penalties for information blocking may threaten the financial viability of small and rural hospitals, according to the American Hospital Association.

Expert Analysis

  • Risk Mitigation In Face Of Rising Legal Malpractice Claims

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    As the recent rise in frequency and cost of legal malpractice claims is expected to continue amid global high inflation and economic uncertainty, law firms and insurers would be wise to evaluate key risk areas and consider six steps to minimize exposure, say Nicole Shapiro and Cory Stumpf at Atheria Law.

  • Unpacking FDA's Final Clinical Decision Support Guidance

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    The U.S. Food and Drug Administration's latest guidance on clinical decision support software introduces new concepts, questions and ambiguities, and may be challenging to implement in practice, say attorneys at Covington.

  • How Cos. Can Adapt To Global AI Regulation Trends

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    Companies can prepare for the future of artificial intelligence regulation by monitoring proposed and existing regulations both in the U.S. and abroad, tailoring their internal compliance architecture for AI-specific risks, and looking for opportunities to lead on governance issues, says Nicholas Diamond at Jackson Walker.

  • 4 Strategies For Drafting Effective Consumer Breach Notices

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    Businesses should consider key strategies when drafting consumer breach notification letters, such as knowing their audience and what is on their mind, and prioritizing user-friendliness and tone, say attorneys at Troutman Pepper.

  • 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.