On December 23, 2025, the U.S. Department of Health and Human Services (HHS) requested information on how the agency can accelerate the adoption of Artificial Intelligence (AI) in the clinical care space. Advocacy hosted a roundtable to solicit feedback on this request for information.
- Clinicians noted multiple barriers to fully integrating AI into existing systems, such as, unreliability of data quality, lack of education and training, and an inability to fully reimburse the costs associated with AI.
- For AI tools not regulated as medical devices, health systems face unresolved challenges related to liability, indemnification, data governance, and accountability. The absence of Food and Drug Administration (FDA) review for certain AI tools may accelerate innovation, but also increases the burden on providers to independently assess safety and appropriateness
- Administrative hurdles include governance complexity, contracting requirements, data access restrictions, and inconsistent regulatory guidance, all of which slow deployment and disproportionately affect smaller hospitals.
- AI tools have exceeded expectations when it functions as time multipliers, particularly in administrative and clinical documentation workflows. But it performs less effectively for underrepresented subpopulations such as pediatric and geriatric patients. There are gaps in the data that AI tools are trained on, which create bias and risk of misdiagnosis or treatment.
COMMENT LETTER
(PDF, 258 KB)
CONTACT: David Mullis
EMAIL: david.mullis@sba.gov
TOPIC(S): Letters to Agencies
TAG(S): HHS