HHS seeks input on how reimbursement, regulation could bolster use of healthcare AI

Health and Human Services is seeking input from the industry on how reimbursement and further regulation could help bolster use of artificial intelligence. 

The key agency released a request for information on Friday, asking for broad input on how it can accelerate the adoption of AI in clinical care. Topics of interest include how AI can help improve the patient experience, reduce provider burden and cut costs for both consumers and the government. 

“Artificial intelligence will be a transformative force for good across America,” HHS Deputy Secretary Jim O’Neill, whose office leads the department’s AI strategy, said in a statement Dec. 19. “We want to hear from you. Our efforts to accelerate AI adoption must be guided by the real needs and experiences of those developing these tools and delivering care.”

O’Neill and colleagues said they’ll seek information on how reimbursement structures can be simplified and better aligned to support the use of “efficient, deflationary technologies.” They’re also curious how research and development investments can strengthen implementation sciences and best practices, “especially for complex or high acuity clinical scenarios.” 

HHS also is interested in input around how digital health and software regulatory frameworks should evolve to account for AI-driven tools. This while focusing on interoperability and ensuring that patient data remains “safe, secure and only used as allowed under HIPAA.” 

“Artificial intelligence is powered by data. Data liquidity and the trust patients and providers have in how data moves are essential,” said Thomas Keane, MD, MBA, an interventional radiologist who was named assistant secretary for technology policy and national coordinator for health IT in June. “Through our interoperability work, we are designing for both, bringing true data access to patients and enabling AI. We look forward to hearing how these tools can best strengthen care.”

The announcement comes as radiology dominates in the number of Food and Drug Administration-cleared algorithms, while reimbursement continues to lag behind. There are now over 1,300 AI-enabled medical devices greenlit by the agency, yet only a select few have scored reimbursement, which experts say is hindering adoption. 

HHS also is encouraging responses that focus on medium- and long-term trends and needs that face the healthcare system. This includes addressing conditions that will emerge or continue to increase in prevalence, such as frailty and dementia. 

“The responses will inform the critical, coordinated activities that will drive enabling change across all HHS divisions,” it added. 

You can find more information in the document, set to be published in the Federal Register on Dec. 23, with comments being accepted for 60 days following that date.