Digital Health & Technology

  • May 30, 2024

    FTC, SEC Urged To Probe UnitedHealth's 'Negligent' Security

    The chair of the U.S. Senate finance committee on Thursday pressed the Federal Trade Commission and the U.S. Securities and Exchange Commission to hold UnitedHealth Group and its top executives liable for "numerous" cybersecurity failings that fueled a debilitating cyberattack on its Change Healthcare unit. 

  • May 30, 2024

    Veradigm Execs Sued Over Company's Nasdaq Delisting

    Current and former members of healthcare technology company Veradigm Inc.'s top brass were sued in Illinois federal court by shareholders alleging that the company suffered stock drops following a string of financial reporting blunders starting in 2021, which caused it to overstate roughly $40 million in revenue before facing a delisting notice from Nasdaq.

  • May 29, 2024

    Greenberg Traurig Adds IP Atty From Eversheds Sutherland

    Greenberg Traurig LLP has bolstered its California bench of attorneys with an Eversheds Sutherland lawyer who has years of experience advising digital health and medical device companies on intellectual property issues.

  • May 28, 2024

    Pharmacy Benefits Co. Taps Health Atty To Lead Legal Team

    RxBenefits, a company focused on generating savings for employers providing pharmacy benefits, has appointed a new chief legal officer to oversee its legal and regulatory compliance efforts.

  • May 24, 2024

    Fla. Lab Owner Will Pay $27M To End False Billing Suit

    A Florida medical lab owner who pled guilty to charges related to accusations he billed Medicare for $53 million in unnecessary genetic cancer screening tests has agreed to pay more than $27 million to resolve three whistleblower suits over the same conduct, according to an announcement Friday from the U.S. Department of Justice.

  • May 23, 2024

    Stryker Unit And Seyfarth Attys Hit With $275K Sanctions

    A Colorado federal judge has imposed $275,000 in sanctions jointly and severally on Stryker-owned Howmedica Osteonics Corp., along with Seyfarth Shaw LLP, for witness coaching and discovery violations in a bitter breach-of-contract dispute, amounting to roughly one-eighth of what plaintiff ORP Surgical LLC had sought.

  • May 22, 2024

    Stryker Agrees To Settle Calif. Misclassification Suit

    Medical device company Stryker told a California federal court Wednesday it has agreed to settle a proposed class action accusing it of misclassifying workers as overtime-exempt and failing to pay them overtime during their mandatory training.

  • May 22, 2024

    Lead Blood Test Maker To Plead Guilty, Pay $42M Over Defects

    Medical device maker Magellan Diagnostics has agreed to pay at least $42 million and plead guilty to hiding a defect in its blood testing devices for lead that caused inaccurately low results for tens of thousands of children and others, Massachusetts federal prosecutors said.

  • May 21, 2024

    Amid Abortion Suit, Ind. Officials Spar Over Report Releases

    Indiana's top lawyer is set to respond to a lawsuit seeking access to doctor-created abortion reports. The case promises to highlight a rift between the state's vocally anti-abortion attorney general and other officials who say the information is off-limits to public records requests.

  • May 21, 2024

    Strategic Hiring Was The New Normal For BigLaw In 2023

    The 400 largest law firms by headcount in the U.S. grew more slowly in 2023 than in the previous two years, while Kirkland & Ellis LLP surpassed the 3,000-attorney threshold, according to the latest Law360 ranking.

  • May 21, 2024

    The Law360 400: Tracking The Largest US Law Firms

    The legal market expanded more tentatively in 2023 than in previous years amid a slowdown in demand for legal services, especially in transactions, an area that has been sluggish but is expected to quicken in the near future.

  • May 17, 2024

    FCA Relators Seek Finders Fee For SpineFrontier Doc Deals

    Three whistleblowers who tipped off the federal government to a medical device company's multimillion-dollar kickback scheme said Friday the Justice Department is refusing to pay them a cut of the $3 million in False Claims Act settlements paid by surgeons who admitted participating in the sham consulting ploy.

  • May 17, 2024

    Ga. OB-GYN Office Says Data Breach Class Action Falls Flat

    An Atlanta OB-GYN practice has urged a Georgia federal judge to dismiss a proposed class suit over a data breach that allegedly impacted the personal and protected health information of tens of thousands of patients, arguing the lead plaintiff has failed to meet the requirements of the Class Action Fairness Act.

  • May 15, 2024

    Blackbaud Dodges Data Breach Victims' Class Cert. Bid

    A South Carolina federal judge has refused to certify several proposed classes consisting of roughly 1.5 billion patients, donors and other individuals whose personal information was allegedly swept up in a 2020 ransomware attack on software provider Blackbaud Inc., finding that the plaintiffs had failed to show that class members could be easily identified. 

  • May 15, 2024

    UnitedHealth Concealed DOJ Merger Investigation, Suit Says

    UnitedHealth Group has been hit with a proposed shareholder class action alleging that it failed to disclose that the U.S. Department of Justice had reopened an antitrust investigation into the health insurance giant following its acquisition of a healthcare data company, and that top executives had sold more than $120 million of shares knowing about the investigation before a news report revealed it to the public.

  • May 14, 2024

    Under Fire For Lab Rule, FDA Remains Open To Lawmaking

    After a difficult run-up to a new federal rule on lab-developed tests, the U.S. Food and Drug Administration official overseeing medical devices voiced support Tuesday for additional lawmaking.

  • May 13, 2024

    Wash. Hospital Scores Exit In Facebook Privacy Suit, For Now

    A Washington federal judge has tossed a proposed class action accusing a Seattle-area hospital of sharing patients' confidential health information by using Facebook browser tracking tools, ruling on Monday the plaintiff has failed to show that her own private information was input into the website and shared with a third party.

  • May 13, 2024

    Philips Wants Cleaner Co. To Chip In For $1B CPAP Deal

    Koninklijke Philips NV has filed a third-party complaint in Pennsylvania federal court against SoClean Inc., which sells cleaning products for breathing devices, claiming SoClean and its parent should contribute to Philips' $1 billion settlement because its cleaners allegedly exacerbated the foam breakdown at the heart of the litigation.

  • May 10, 2024

    Retail Group Opposes $1B Arbitral Award Against Walgreens

    An advocacy group for the retail industry is backing Walgreens as it looks to set aside a nearly $1 billion arbitral award in a dispute with a COVID test maker, telling a Delaware federal judge that judicial intervention is warranted in this case.

  • May 10, 2024

    No 'Piecemeal' Fees For Infant Data Win Amid 6th Circ. Appeal

    A federal judge said Friday that he wouldn't award attorney fees to children who challenged Michigan's handling of blood samples collected in an infant health screening program until the state's Sixth Circuit appeal is resolved.

  • May 08, 2024

    Fla. Lab Owner Gets 10 Years For Unneeded Medical Tests

    A Florida medical lab owner has been sentenced to 10 years in prison after pleading guilty to charges related to accusations that he billed Medicare for $53 million in unnecessary genetic cancer screening tests.

  • May 07, 2024

    MultiPlan, Insurance Cos. Accused Of Algorithmic Collusion

    A medical provider has lodged a proposed class action in Illinois federal court accusing MultiPlan and major insurance companies, including UnitedHealth, Aetna, Kaiser Permanente and Cigna, of using pricing tools to systematically underpay out-of-network providers.

  • May 07, 2024

    New FDA Device Rule No Cure For Unregulated Lab Tests

    The U.S. Food and Drug Administration's newly claimed authority over lab-developed tests will leave untold numbers of unregulated — and in some cases, inaccurate or otherwise faulty — tests in the hands of clinicians.

  • May 06, 2024

    Hooper Lundy Adds Government Relations Director

    An attorney who worked in-house for healthcare industry trade and advocacy associations has joined healthcare boutique Hooper Lundy & Bookman PC as director of government relations and public policy.

  • May 03, 2024

    Ala. High Court Won't Rethink Decision On Frozen Embryos

    The Alabama Supreme Court on Friday refused to revisit its February decision finding that frozen embryos count as children, a first-of-its-kind decision that has been received as potentially ruinous for in vitro fertilization services in the Yellowhammer State.

Expert Analysis

  • How Growing Cyber Scrutiny Affects Corporate Compliance

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    In the face of overlapping cybersecurity initiatives at the U.S. Departments of Justice and Health and Human Services, health care companies and government contractors should prepare for microscopic scrutiny by ensuring specific components are included in compliance programs and being mindful of reporting obligations under existing corporate integrity agreements, say attorneys at Verrill Dana.

  • Choosing The Right IP Protections For Telehealth Innovations

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    Telemedicine and digital health innovations are likely to stay after the COVID-19 pandemic ends, so inventing companies must decide on a comprehensive intellectual property strategy, considering the goals, risks and upfront requirements offered by both patent and trade secret protections, say Eric Sophir and Matthew Horton at Foley & Lardner.

  • A Phased Approach To In-House Legal Tech Adoption

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    In-house legal departments that adopt new technologies too quickly often face frustration or failure, so to help ensure a smooth transition, companies should consider a multistep approach, depending on where they stand with respect to modernizing legal processes, says Tariq Hafeez at LegalEase Solutions.

  • 3 Practice Tips For Patenting Medical Devices In A Digital Age

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    In light of a recent surge in digital therapeutic applications that help manage or treat diseases, there are several best practices to follow when patenting medical devices and software, including improving upon existing technology and making the claims as specific as possible, say attorneys at Crowell & Moring.

  • How To Minimize FCA Cyber Fraud Enforcement Risk

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    As the U.S. Department of Justice’s new Civil Cyber-Fraud Initiative signals a rise in False Claims Act enforcement and whistleblower actions for cybersecurity-related fraud, government contractors and grantees should take five preventative steps to mitigate increased risks, say Brenna Jenny and Sujit Raman at Sidley.

  • What Blockchain Means For The Future Of US Health Care

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    As the U.S. plays catchup with other countries that have introduced blockchain into their health care systems, the technology is poised to drastically change the industry's revenue cycles, data management and beyond, which will result in better care for patients and more assurance for provider reimbursements, say Michael Ruggio and Jacob Butz at Ice Miller.

  • How To Navigate California's New Intrastate CBD Route

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    Businesses and consumers should prepare for rigorous compliance checks on manufacture, distribution and retail sale of consumer products made with CBD and other hemp-derived cannabinoids. following California's new law opening the potentially enormous market for these items, says Christian Foote at Clark Hill.

  • Manufacturers Face Evolving COVID-19 Legal Challenges

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    Product manufacturers must adopt new strategies to defend against pandemic-related legal challenges, including discovery delays in health care litigation, novel consumer protection claims, aggressive government enforcement actions and supply chain disputes, says Stephanie Laws at Maslon.

  • FTC's Hasty Health Data Rule Change Could Cause Confusion

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    The Federal Trade Commission's recent policy statement expanding the scope of its Health Breach Notification Rule appears to bypass appropriate administrative processes and may delay effective privacy and security policies that can advance interoperability and health innovation, says Jodi Daniel at Crowell & Moring.

  • 'McMorris Factors' Create Obstacles For Data Breach Plaintiffs

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    The factors for evaluating standing in the context of data breach allegations set forth by the Second Circuit in McMorris v. Carlos Lopez & Associates earlier this year may be difficult, if not impossible, for plaintiffs to satisfy, but the standard varies from circuit to circuit, say David Topol and Pamela Signorello at Wiley.

  • Telehealth Providers Must Beware Of Fraud As Industry Grows

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    A recent fraud charge against a telehealth executive highlights the rise we're seeing in telefraud scams during the industry's pandemic growth, and there are some steps that all health providers should take to stay clear of potentially illegal arrangements, says LaTawnda Moore at Dinsmore.

  • The Regulatory Growing Pains For Digital Health Companies

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    The meteoric rise of digital health services during the pandemic has been matched with increasing regulatory scrutiny in the U.S. and abroad, resulting in a patchwork of laws and approaches that could leave a damper on the industry's growth, say attorneys at Kobre & Kim.

  • Policyholder Best Practices As Cyberattacks Escalate

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    As ransomware attacks increasingly target corporate victims, policyholders should enhance cybersecurity and privacy efforts to avoid regulatory hot water and mitigate the effects of rising insurance premiums and coverage restrictions, say Lee Epstein and Krishna Jani at Flaster Greenberg.