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Health Law Highlights

Pharmacy Association and 40 Providers Sue Change Healthcare Over Cyberattack

Summary of article from The HIPAA Journal, by Steve Adler:

The National Community Pharmacists Association (NCPA) and over 40 healthcare providers from 22 states are suing Change Healthcare, Optum, and UnitedHealth Group following a February 2024 ransomware attack. This Blackcat ransomware incident resulted in significant disruptions, as Change Healthcare’s critical systems were taken offline, affecting claims processing and revenue management for numerous providers nationwide. The plaintiffs argue that the defendants failed to implement adequate security measures and did not provide timely guidance or support, exacerbating financial hardships for healthcare providers. The lawsuit, which spans 140 pages, includes claims of negligence, breach of contract, and violations of various state consumer protection laws. It seeks permanent injunctive relief, enhanced security measures, and various forms of damages.

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Health Law Highlights

AI and Digital Governance: Exploring Platform Liability

Summary of article from IAPP, by Uzma Chaudhry:

The modern internet, integrating AI, IoT, and advanced cybersecurity, is a rapidly evolving ecosystem with significant societal impact, accessible to 5.35 billion people globally. This digital landscape has increased the influence of intermediaries like search engines and social media, raising concerns about privacy, misinformation, and intermediary liability under laws such as Section 230 of the Communications Decency Act, Section 512 of the : Digital Millennium Copyright Act, and the EU e-Commerce Directive. The rise of generative AI adds complexity, challenging existing legal frameworks and prompting discussions on whether current immunities should extend to AI-generated content. Recent cases like Gonzalez v. Google highlight ambiguities in intermediary liability, particularly as AI technologies evolve. Future legal interpretations will need to address the nuances of AI and its role in content creation and dissemination.

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Health Law Highlights

The Wearable Revolution: How to Use Personal Health Device Data in Litigation

Summary of article from Butler Snow LLP, by Katelyn Ashton, Susanna Moldoveanu:

Wearable technology can play an important role in civil litigation due to its ability to collect extensive health and activity data, such as heart rate, sleep patterns, and physical activity. This data can provide critical evidence in personal injury and product liability cases, helping to substantiate or refute claims about a plaintiff’s physical condition and activity levels before and after an alleged incident. Legal standards for discovering and admitting such data are evolving, with courts generally supporting its relevance while balancing privacy considerations. Strategic use of written discovery requests, specific data formats, and expert testimony can effectively incorporate wearable device data into legal proceedings. This shift underscores the growing evidentiary value of personal health data from wearable devices.

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Health Law Highlights

Healthcare Chatbots: When Do They Help and When Do They Hurt?

Summary of article from Built In, by Alexandra Whitt:

Healthcare chatbots offer significant benefits, including improved user engagement, quick responsiveness to minor health queries, reduced administrative workload, enhanced customer satisfaction, and better advocacy for health and wellness programs. They streamline processes such as appointment scheduling and insurance claims, providing 24/7 access to critical information. However, chatbots face limitations like lacking empathy, potential for incomplete assessments, data security risks, and the overwhelming variety of options available. While they enhance efficiency and accessibility in healthcare, it is crucial to recognize their limitations and ensure they complement rather than replace professional medical advice.

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Health Law Highlights

The Rise of Fiduciary Health Plan Litigation

Summary of article from The Wagner Law Group, by Michael Schloss, Stephen Wilkes:

In 2022, US health care spending reached $4.5 trillion, with $405 billion spent on prescription drugs and $800 billion paid through employer-sponsored health plans. A class action lawsuit, Lewandowski v. Johnson and Johnson, alleges mismanagement of the company’s health plans’ prescription-drug benefits, leading to higher costs for plan participants. The complaint argues that the company breached ERISA duties of prudence and loyalty and calls for various remedies. The defendants have filed a motion to dismiss the original complaint, arguing that the plaintiff received all benefits due to her under the plans and failed to plausibly allege an imprudent process for negotiating PBM services. The case serves as a wake-up call for health plan fiduciaries to review their PBM programs and consider the role of incentives and conflicts, among other measures.

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Health Law Highlights

Humana Can Challenge Medicare Clawback Rule

Summary of article from Reuters, by Brendan Pierson:

Humana can proceed with its lawsuit against a Biden administration rule that enables Medicare to reclaim overcharges from insurers. The rule, established in January 2023, permits the government to recoup payments to Medicare Advantage plans when audits reveal charges for diagnoses not present in patients’ medical records. The Biden administration believes this could help recover around $4.7 billion over a decade. Humana argues the rule is “arbitrary and capricious,” with potential unforeseen consequences for Medicare Advantage organizations and beneficiaries. The judge rejected the administration’s request to dismiss the case, stating that the perceived risk of future harm was enough to establish standing.

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Health Law Highlights

Wegovy Maker Novo Nordisk Sues Nine Spas, Clinics and Pharmacies Over Copycat Drugs

Summary of article from Reuters, by Patrick Wingrove:

Novo Nordisk, a Danish pharmaceutical company, has filed lawsuits against nine more U.S. entities, including medical spas, wellness clinics, and pharmacies, for selling products that allegedly contain semaglutide, the key ingredient in its weight-loss drug Wegovy. This brings the total lawsuits to 21 since June, targeting sellers of purported copycat versions of semaglutide. The recent lawsuits were filed in federal courts across six states, with some defendants accused of selling products directly to patients without medical prescriptions and others of selling products with no semaglutide or of lower strength than advertised. Novo Nordisk also found high levels of impurities in some products, posing significant health risks to patients. This legal action mirrors similar steps taken by Eli Lilly, Novo Nordisk’s main competitor in the obesity drug market, against entities selling products claiming to contain tirzepatide, the active ingredient in its weight-loss drug Zepbound.

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Health Law Highlights

Houston Transplant Scandal: Families of Patients Who Died Begin Legal Action

Summary of article from MedPage Today, by Associated Press:

Relatives of deceased patients are demanding an investigation into a Houston doctor, J. Steve Bynon Jr., MD, who is accused of manipulating the liver transplant waitlist at Memorial Hermann-Texas Medical Center. The hospital has suspended its liver and kidney transplant programs after discovering “inappropriate changes” in the national database for liver transplant recipients. A temporary restraining order has been filed to prevent Bynon from deleting or destroying evidence. Meanwhile, a lawsuit alleging negligence has been filed against the hospital and UTHealth Houston by a woman whose husband died while on the waitlist. The death rate for patients awaiting a liver transplant at Memorial Hermann was higher than expected, according to data from the Scientific Registry of Transplant Recipients.