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Digital Health & Technology

  • July 05, 2024

    The Firms That Won Big At The Supreme Court

    This U.S. Supreme Court term featured high-stakes oral arguments on issues including gerrymandering, abortion and federal agency authority, and a hot bench ever more willing to engage in a lengthy back-and-forth with advocates. Here's a look at the law firms that argued the most cases and how they fared.

  • July 03, 2024

    Appeals Board Tosses Revived License Breach Dispute

    The Civilian Board of Contract Appeals has again tossed a dispute, previously revived by the Federal Circuit, alleging the U.S. Food and Drug Administration breached a software company's end-user license agreement, saying it lacks jurisdiction to enforce the agreement.

  • July 03, 2024

    Cooley DQ'd From IP Case Over Atty's Past Patent Work

    Cooley LLP was disqualified on Wednesday from representing a pharmaceutical customer-support software company against patent infringement claims in Delaware, with the district court citing a Cooley partner's prior work representing the plaintiff and Cooley's refusal to screen its attorney.

  • July 02, 2024

    Whistleblower Or Felon? Texas Doc Faces Rare HIPAA Charge

    The fate of a criminal case against a Texas surgeon accused of using deception to get protected patient information may hinge on whether a jury buys prosecutors' story that Dr. Eithan Haim was pursuing a "personal agenda" or his likely defense: that he was an honest whistleblower concerned about gender-affirming care for minors.

  • July 01, 2024

    Feds Say Ex-Magellan Officer's Atty May Have Conflict

    A Donnelly Conroy & Gelhaar LLP attorney's prior representation of co-defendants in a pending fraud case against former executives of medical device company Magellan Diagnostics may have created a disqualifying conflict of interest, lawyers for the government told a Massachusetts federal judge.

  • June 28, 2024

    Chevron's End Is Just The Start For Energized Agency Foes

    By knocking down a powerful precedent that has towered over administrative law for 40 years, the U.S. Supreme Court's right wing Friday gave a crowning achievement to anti-agency attorneys. But for those attorneys, the achievement is merely a means to an end, and experts expect a litigation blitzkrieg to materialize quickly in the aftermath.

  • June 28, 2024

    In Chevron Case, Justices Trade One Unknown For Another

    The U.S. Supreme Court's decision to overrule a decades-old judicial deference doctrine may cause the "eternal fog of uncertainty" surrounding federal agency actions to dissipate and level the playing field in challenges of government policies, but lawyers warn it raises new questions over what rules courts must follow and how judges will implement them.

  • June 27, 2024

    Fla. Gov. Vetoes Bill Giving Immunity On Data Breach Claims

    Florida Gov. Ron DeSantis on Wednesday vetoed a bill that would have provided immunity from data breach lawsuits for businesses that complied with certain cybersecurity standards, citing concerns that the legislation could result in Floridians' data being less secure.

  • June 27, 2024

    High Court Allows Idaho Emergency Abortions, For Now

    The U.S. Supreme Court on Thursday allowed abortions in Idaho to continue in emergency situations under a federal law requiring doctors at Medicare-funded hospitals to provide emergency care, including abortions.

  • June 26, 2024

    State Data Privacy Âé¶¹´«Ã½ Patchwork: Midyear Report

    States jumped on the consumer data privacy law bandwagon at a brisk clip in the first half of 2024, although it remains unclear if this push will be enough to encourage Congress to finally enact a nationwide framework this year. 

  • June 26, 2024

    Apple Watch Improvement Is 'Inferior,' Docs Tell 9th Circ.

    Four cardiac specialists backed medical monitoring startup AliveCor against Apple in a Ninth Circuit amicus brief Tuesday arguing a district court wrongly nixed antitrust claims by crediting the phaseout of a heart rate monitoring algorithm as an improvement when all it did was deny patient access to "potentially life-saving" technology.

  • June 25, 2024

    Judge Likely To Block Medical Record Co.'s Anti-Bot CAPTCHAs

    A Maryland federal judge appeared ready to enjoin electronic medical records company PointClickCare from restricting nursing home analytics company Real Time Medical Systems' automated access to its online repositories Tuesday, potentially taking an early crack at defining the 21st Century Cures Act's data sharing provisions.

  • June 24, 2024

    $2.9M Health Co. Data Breach Settlement Gets Final Approval

    A Michigan federal judge has given final approval to a $2.9 million deal for a maker of prosthetics and orthotics to settle claims the company didn't protect customers' sensitive information from a cyberattack.

  • June 20, 2024

    Web-Tracking Guidance Exceeded HHS' Authority, Judge Says

    A Texas federal judge ordered the Biden administration Thursday to rescind its new guidance restricting hospitals' use of online tracking technology, declaring that federal officials had overstepped their authority by redefining what they consider protected health information.

  • June 18, 2024

    Novant Pays $6.7M For Sharing Patient Data With Facebook

    A North Carolina federal judge on Monday gave the final seal of approval to a proposed $6.7 million deal resolving litigation alleging Novant Health Inc. shared sensitive patient data with Facebook, certifying a nationwide settlement class of roughly 1.3 million individuals.

  • June 18, 2024

    COVID Test Maker Can't Shake All Of $30M Faulty Kit Suit

    A New Jersey federal judge won't let California-based laboratory equipment maker Atila Biosystems Inc. out of a suit alleging it sold faulty COVID-19 testing kits, saying Fusion Diagnostic Laboratories LLC has adequately pled a breach of contract claim.

  • June 18, 2024

    Gene Therapy Co. Taps Experienced Bioscience Legal Chief

    Kriya Therapeutics Inc., which develops gene therapies to address common diseases, said Tuesday it has chosen a veteran bioscience general counsel to be its chief legal officer.

  • June 17, 2024

    Calif. Becomes Last State To Ink Deal Over Blackbaud Breach

    Blackbaud Inc. has agreed to pay $6.75 million to resolve data security claims brought by California's attorney general, who was the only one to sit out a nearly $50 million settlement that the software provider reached last year with every other state over a 2020 ransomware attack that affected thousands of its customers.

  • June 17, 2024

    Ex-Stimwave CEO Gets 6 Years For Dummy Implant Scheme

    The founder and former CEO of Stimwave Technologies was sentenced to six years in prison Monday after tearfully proclaiming her innocence to healthcare fraud charges, with a Manhattan federal judge saying it's "sad" the defendant doesn't recognize the harm she inflicted by selling nonfunctional pain management device components.

  • June 13, 2024

    IP Forecast: Cooley Atty Faces DQ Bid Over Past Patent Work

    A prominent Cooley LLP lawyer will face questions next week in a Philadelphia courtroom over her work a decade ago at her former firm defending a cloud software startup that is now suing a Cooley client. Here's a spotlight on that case — plus all the other major intellectual property matters on deck in the coming week.

  • June 10, 2024

    5 Teva Inhaler Patents Kicked Out Of Orange Book

    A New Jersey federal judge said Monday that a handful of patents covering Teva-brand asthma inhalers were "improperly listed in the Orange Book," a legal holding that U.S. Federal Trade Commission Chair Lina Khan quickly took some credit for.

  • June 10, 2024

    Rehab Clinics Add To MultiPlan Insurance Fixing Pile-On

    Addiction treatment providers sued MultiPlan, Aetna, Cigna, UnitedHealth and Elevance Friday and Saturday in 14 separate New York federal court complaints that appear to be the first to add substance abuse disorder-specific allegations to the cases pegging MultiPlan at the center of a scheme to suppress insurer payouts.

  • June 10, 2024

    Health Data Co. Says Rival's Request Risks Patient Security

    A healthcare data company pushed back against claims in Maryland federal court that it blocks a rival's access to nursing home patient data used to identify potential complications, saying the rival is asking to disable security measures that prevent attacks on its system.

  • June 10, 2024

    Medical-Aesthetic Device Rivals Set For Sept. Poaching Trial

    A Boston federal judge on Monday scheduled a post-Labor Day jury trial for medical-aesthetic device company Cynosure's $78 million poaching lawsuit against rival Reveal Lasers, urging the parties to streamline their exhibits and damages claims.

  • June 07, 2024

    DC Circ. Undoes Library Of Congress Win In Fair Use Fight

    The D.C. Circuit on Friday reversed a lower court's decision that had rejected two industry groups' challenge to a final rule that categorized medical device diagnostic procedures and repairs as fair use exemptions to U.S. copyright law.

Expert Analysis

  • 9 Legal Ethics Considerations In Natural Disaster Preparation

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    Since natural disasters like Hurricane Ian do not relieve lawyers of their ethical obligations to clients, law firms should focus their preparedness efforts on specific areas crucial to continuity of representation and ethics compliance, like business and communications contingency planning, record redundancy and more, says Mark Hinderks at Stinson.

  • NY Data Breach Penalty Expands Regulatory Requirements

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    The New York Department of Financial Services’ recent consent order with EyeMed is an aggressive reading of state regulation that arguably expands current requirements, which could increase the complexity of the risk assessment process and may serve as a precedent for other privacy and data security regulators, says Rick Borden at Frankfurt Kurnit.

  • Cybersecurity Expectations Intensify For Medical Device Cos.

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    A recent FBI industry notification and U.S. Food and Drug Administration draft guidance highlight urgent compliance considerations for medical device manufacturers, and contrasts with how federal regulators have previously treated health care players as victims in cybersecurity incidents, say attorneys at Morrison Foerster.

  • 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 Âé¶¹´«Ã½.

  • 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.