Health Law Advisor

During a recent industry webinar, Cara Welch, Ph.D., Director of the Office of Dietary Supplement Programs (“ODSP”) within the U.S. Food and Drug Administration (“FDA”), outlined the agency’s 2026 priorities for the dietary supplement industry. Dr. Welch’s remarks reflect both continuity in FDA’s long-standing focus areas and a push toward modernization within existing statutory authority.

Last week, the OIG posted two important issuances on Direct to Consumer drug programs, including TrumpRx – a Special Advisory Bulletin and a Request for Information (RFI). These issuances follow the announcement of Most Favored Nation Direct to Consumer pricing last May in White House Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” (May 12, 2025).

On January 16, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 26-01, offering clarity as to whether a manufacturer may waive patient cost-sharing amounts for certain insured individuals receiving its clinical diagnostic test without triggering liability under the Federal health care fraud and abuse laws.

Following CES2026, OpenAI and Anthropic announced consumer-facing generative AI products for health care. OpenAI launched ChatGPT Health on January 7, 2026, and Anthropic followed with Claude for Healthcare on January 11, 2026. Both products allow users to connect their medical records and wellness data directly to these AI chatbots, marking a significant change from theoretical benchmark performance to deployment of consumer health applications.

On December 29, 2025, the U.S. Department of Health and Human Services (“HHS”) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (“ASTP/ONC”) published two proposed rules in the Federal Register:

As the health care industry transitions beyond the COVID-19 public health emergency era, Congress continues to demonstrate bipartisan support for expanding access to telehealth.

However, telehealth providers will invariably encounter certain legal and regulatory complexities as lawmakers work toward establishing a more permanent regulatory framework. At the same time, states are moving from broad expansion to refinement, focusing on reimbursement precision and licensure compacts.

We are pleased to once again release our latest update to our Telemental Health Laws app, an extensive compilation of laws, policies, and other state guidance for practitioners supporting the mental/behavioral health practice disciplines.

The survey’s complete findings are available to download for free as an app for iPhone, iPad, and Android devices.

On January 5, 2026, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion No. 25-12 (“AO 25-12”), an unfavorable opinion regarding sign-on bonuses offered to caregivers who provide in-home support services to Medicaid recipients.

The Trump Administration continues to pursue a policy of AI dominance, which began with its January 23, 2025 executive order to remove “barriers” to Artificial Intelligence (“AI”) innovation to promote “human flourishing, economic competitiveness and national security.” On December 11, 2025, the Administration issued another executive order announcing a policy to remove state law impediments to adopting a “minimally burdensome national standard” for AI development and use.

Tuesday, January 6, 2026, yielded two surprising updates from the Food and Drug Administration (“FDA”) Center for Devices and Radiological Health. While many experts have been forecasting continued tension between med tech innovators and the agency based on enforcement trends in 2025, FDA released two policy updates that, in fact, purport to ease the burdens on developers of certain wearables and clinical decision support (“CDS”) software tools.

This blog post is the latest installment in a series focused on the DOJ’s Bulk Sensitive Data Rule, and is intended to help stakeholders navigate the complex rule’s requirements and move toward full compliance.

Epstein Becker Green’s previous blog post on this topic encouraged U.S. organizations across all industries with cross-border operations – including health care/life sciences, finance, e-commerce, and research – to “know their data.”  In this post, we discuss why it is critical for these organizations to also “know their vendors.” We discuss how the BSD Rule imposes new requirements on U.S.-based companies to monitor and scrutinize vendor engagements beyond those with the six designated countries of concern.