Without FDA Regulation, AI Tech in Healthcare Poses Dire Risks to Patients

November 21, 2024

Without FDA Regulation, AI Tech in Healthcare Poses Dire Risks to Patients

Washington, D.C. - As artificial intelligence (AI) quickly seeps into our everyday life, Public Citizen experts are urging the U.S. Food and Drug Administration (FDA) to consider the risks of AI in our healthcare system which could exacerbate existing problems and harm patient safety.

On Thursday, Health Research Group Director Dr. Robert Steinbrook testified before the FDA's Digital Health Advisory Committee to highlight the potential ramifications of using AI programs in healthcare without stringent regulations.

"When companies cut corners in rapidly developing and implementing GenAI devices, patients are at risk for harm," said Steinbrook. "There is justified concern that without robust oversight - that is, oversight that is more stringent and demanding than current requirements - the risks of harm will substantially increase."

A new reportauthored by Public Citizen Health Care Policy Advocate Eagan Kemp outlines three areas of growing AI use:

• AI-enabled programs intended to help healthcare staff and institutions with administrative tasks
• AI-enabled tech intended to improve medical practices
• Growing number of AI-enabled mental health support programs

Kemp said adding AI into a fragmented and profit-driven U.S. healthcare system without developing regulatory safeguards leaves patients vulnerable to inequitable care.

"We must take a step back and see that despite some promising outcomes, artificial intelligence could lead to institutions prioritizing profit or efficiency over patient care," said Kemp. "There are already existing gaps in our healthcare system, and these programs and tools could increase healthcare costs, exacerbate health and racial disparities and supplant healthcare staff."

In April, Public Citizen drafted a list of recommendationsto the Department of Health and Human Services (DHHS) on AI regulations in healthcare. Considering the anticipated challenges presented by the incoming administration, it's important to further elevate the dangers presented by AI in healthcare.

"With much of the implementation of AI requirements in healthcare now falling to the incoming Trump administration, we can anticipate an emphasis on spurring innovation in AI over regulation, potentially at the expense of patients and providers," said Kemp.

Check out Public Citizen's fact sheet on AI in healthcare here.