Healthcare Compliance Alert: Navigating the New Biological Research Safety Mandates

On May 5, 2025, President Donald Trump signed the Executive Order on Improving the Safety and Security of Biological Research, marking a pivotal shift in U.S. biosecurity policy. This directive halts federal funding for "dangerous gain-of-function" (GoF) research, particularly in countries like China and Iran, where oversight is deemed insufficient. The move responds to concerns that such research—enhancing pathogens' transmissibility or virulence—could lead to lab accidents with catastrophic consequences, as speculated in the origins of COVID-19.

The order mandates the Office of Science and Technology Policy (OSTP) to collaborate with federal agencies to:

• Cease funding for high-risk GoF research abroad.

• Suspend ongoing domestic projects involving dangerous pathogens.

• Develop a comprehensive oversight framework within 120 days.

• Implement stringent compliance clauses in federal research contracts.

Healthcare entities engaged in biomedical research must now navigate a complex regulatory landscape. Compliance isn't optional; it's imperative. Institutions must audit current projects, reassess collaborations, and ensure alignment with the forthcoming policies.

At Lanton Law, we specialize in guiding healthcare organizations through regulatory transformations. Our expertise ensures that your research initiatives remain compliant and ethically sound. To understand how this executive order impacts your operations and to develop a proactive compliance strategy, contact us today.