Congressional Caucus Explores AI's Role in Clinical Trial Diversity and Healthcare Delivery

The U.S. House Committee on Energy and Commerce convened on September 4, 2025, to discuss the potential of artificial intelligence (AI) technologies in advancing American health care. The meeting focused on the integration of AI in clinical settings, particularly in enhancing patient care and improving clinical trial participation.

The session began with a discussion on the necessity of large datasets that accurately represent diverse subgroups, including children, rural populations, and individuals with rare conditions. Experts emphasized that while algorithms may perform well across these groups, biases can still emerge at the point of care due to deployment practices. A representative from Stanford University highlighted that despite having effective algorithms to identify patients needing additional services, disparities in access remain based on patient demographics and geographic location. This underscores the need for increased outreach and clinic capacity to ensure equitable access to care.

The conversation then shifted to the role of AI in clinical trial recruitment and retention. A co-chair of the Digital Health Caucus expressed interest in understanding how AI can facilitate the identification of eligible patients for clinical trials. A Stanford researcher shared insights on a new tool that allows for querying medical records to find patients who meet specific criteria for trials. However, it was noted that identifying patients is only part of the challenge; convincing them to participate remains a significant barrier. The importance of human engagement in building trust within communities was emphasized as essential for improving trial enrollment.

The meeting also addressed the rapid growth of AI in health care, particularly in the approval of AI-enabled medical devices. Over the past decade, the number of FDA approvals for such devices has surged from six to over 600. A committee member pointed out that while the Centers for Medicare & Medicaid Services (CMS) has begun to cover some software-based technologies, there is a need for a more consistent pathway for these devices under Medicare. This led to discussions about the HealthTech Investment Act, which aims to streamline the approval process for AI technologies in health care.

In conclusion, the committee's discussions highlighted the transformative potential of AI in health care, while also recognizing the challenges of bias, access, and patient engagement. The meeting underscored the importance of thoughtful implementation and policy support to ensure that AI technologies benefit all segments of the population. Further steps will be necessary to address these issues and enhance the integration of AI in clinical practice.