On June 10th, Sheppard Mullin partner Carolyn Metnick and associate Esperance Becton, in collaboration with Marsh McLennan, presented the CLE webinar, “Navigating Healthcare Risks in a Rapidly Evolving Patient and Provider Centered AI Landscape.” The session addressed the growing legal, operational, and ethical risks of AI adoption in healthcare, emphasizing the importance of thoughtful governance and risk mitigation. Key discussion points included regulatory compliance, implementation strategies, liability trends, Marsh’s generative AI risk framework, and insurance considerations.Continue Reading Key Insights from Sheppard Mullin and Marsh McLennan’s Webinar on Navigating Healthcare Risks in a Rapidly Evolving AI Landscape

Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote of 215-214, the One Big Beautiful Bill Act (OBBBA), a budget reconciliation bill with a provision imposing a 10-year moratorium on the enforcement of most state and local laws that target AI systems. If enacted, OBBBA would pause the enforcement of existing state AI laws and regulations and take precedence over emerging AI legislation in state legislatures across the country.Continue Reading The One Big Beautiful Bill Act’s Proposed Moratorium on State AI Legislation: What Healthcare Organizations Should Know

In a recent decision with important implications for artificial intelligence (AI) driven innovation, the Patent Trial and Appeal Board (PTAB) denied a patent for an AI-based medical tool.[1] The refusal was not because the invention was not new or inventive. Rather, the refusal was because the invention did not meet a fundamental rule of U.S. patent law. In Ex parte Michalek, the PTAB specifically acknowledged that the patent claims at issue recited new information about the nexus between certain biomarkers and the development of lung cancer as facilitated by machine learning. In fact, prior to appeal, the applicant had successfully refuted all arguments raised by the patent examiner that the invention was not new or nonobvious. That said, based on U.S. Patent Office guidance and a related example from that guidance, the PTAB still determined the claims were flawed based on the legal principle of subject matter eligibility. Although the facts in this decision concern medical health innovation, the decision is helpful to inform patent strategy for AI-enabled inventions across various disciplines and industries.Continue Reading PTAB Rejects AI-Driven Medical Patent – Not for Novelty, But Eligibility

Utah is one of a handful of states that has been a leader in its regulation of AI. Utah’s Artificial Intelligence Policy Act[i] (“UAIPA”) was enacted in 2024 and requires disclosures relating to consumer interaction with generative AI with heightened requirements on regulated professions, including licensed healthcare professionals.Continue Reading Utah Enacts AI Amendments Targeted at Mental Health Chatbots and Generative AI

As we stride further into 2025, the pharmacy industry faces a landscape teeming with challenges and opportunities. From tackling drug price transparency to juggling implementation of artificial intelligence, the industry is being transformed before our eyes. The journey ahead is anything but straightforward, with solutions ranging from bold, large-scale changes to more nuanced, focused innovations. Let’s delve into the high-level, dynamic trends shaping the pharmacy world today.Continue Reading Navigating the Evolving Pharmacy Landscape in 2025: Challenges, Opportunities and Innovations

The integration of artificial intelligence (AI) tools in healthcare is revolutionizing the industry, bringing efficiencies to the practice of medicine and benefits to patients. However, the negotiation of third-party AI tools requires a nuanced understanding of the tool’s application, implementation, risk and the contractual pressure points. Before entering the negotiation room, consider the following key insights:Continue Reading Key Considerations Before Negotiating Healthcare AI Vendor Contracts

2024 marked a notable year in AI and healthcare, with AI being top of mind for all healthcare players, including providers, technology companies, developers and regulators. The adoption of AI into clinical settings became more common, as scribe and clinical-decision support products gained popularity and EMR vendors incorporated AI tools into their products. The federal government released guidance, established task forces and implemented the directives of the 2023 Executive Order on AI. Similarly, state regulation began to unfold with some states passing legislation around AI’s use in healthcare.Continue Reading Healthy AI: 2024 Year in Review

Texas is joining a growing number of states in considering comprehensive laws regulating use of AI. In particular, the Texas Legislature is scheduled to consider the draft “Texas Responsible AI Governance Act” (the “Act”), which seeks to regulate development and deployment of artificial intelligence systems in Texas. Critically, as most states continue to grapple with the emergence of AI, the Act could serve as a model for other states and could prove tremendously impactful.Continue Reading Texas Considers Comprehensive AI Bill

On November 25, 2024, the Illinois State Legislature introduced House Bill 5918 IL HB5918, the Artificial Intelligence Systems Use in Health Insurance Act (“AI Act”). It provides the Illinois Department of Insurance (the “Department”) regulatory oversight of insurers using artificial intelligence for determinations that affect consumers. The proposed bill grants the Department the ability to adopt rules, including emergency rules per the Illinois Administrative Procedure Act, to implement and administer the AI Act.Continue Reading Artificial Intelligence Infiltrating Healthcare in Illinois and its Effects on Insurers

On September 28, 2024, Governor Gavin Newsom signed into law California Assembly Bill 3030 (“AB 3030”), known as the Artificial Intelligence in Health Care Services Bill. Effective January 1, 2025, AB 3030 is part of a broader effort to mitigate the potential harms of generative artificial intelligence (“GenAI”) in California and introduces new requirements for healthcare providers using the technology.Continue Reading California Passes Law Regulating Generative AI Use in Healthcare

California Governor Newsom signed Senate Bill 1120 into law, which is known as the Physicians Make Decisions Act. At a high level, the Act aims to safeguard patient access to treatments by mandating a certain level of health care provider oversight when payors use AI to assess the medical necessity of requested medical services, and by extension, coverage for such medical services.Continue Reading California Limits Health Plan Use of AI in Utilization Management