FDA Commissioner Charts Potential & Challenges of Emerging Technologies in Patient Care

WASHINGTON, D.C.—Problems with representativeness, disparities, algorithmic bias, the disruptive emergence of large language models and continued misinformation spread are key issues poised to transform patient care in American healthcare, U.S. Food & Drug Administration (FDA) commissioner Robert M. Califf, MD, said during a recent event.

Dr. Califf

Speaking at the Science of Patient Engagement Symposium organized by the National Health Council (NHC) in May, Dr. Califf noted these developments could harm patient care if they remain mostly unchecked by such channels as government agency scrutiny and federal regulation.

He especially warned about the potential pitfalls of large language models, such as ChatGPT. “If we’re not nimble in the use and regulation of large language models, we’ll be swept up quickly by something that we hardly understand,” Dr. Califf said during the event’s keynote speech, hosted by the National Press Club.

Dr. Califf also spoke in some detail about the other aforementioned key issues facing healthcare leaders, as patient involvement (either by patients themselves or their caregivers) and digital health “converge” as increasingly influential forces in the space.

Regarding representativeness, Dr. Califf said that although researchers can now interact with “almost the entire spectrum” of people facing a disease or at-risk for contracting it, “we will eventually need to address the diversity of values, preferences, beliefs, living circumstances and economic factors by directly measuring them in broader populations. The balance of benefits and risks can look quite different for a [new medical] product depending upon preferences that vary across a population.”

The ”dramatic” in the U.S. during the past few years is due not just to the oft-cited COVID-19 pandemic, gun violence, suicide and opioid overdoses, but also because of “the ongoing rise in chronic diseases and their sequalae, like stroke and heart attack,” he said. Research has revealed “stark” differences among rates of people suffering from these conditions by race, ethnicity, sex, education, rural living status and wealth.

“As a [retired] cardiologist, I thought we had solved this 20 years ago,” the 71-year-old former member of the FDA Cardiorenal Advisory Panel said of the rise in heart disease, in particular.

Innovators and technology drivers can help address this disparities trend, he added, by targeting new technologies at a larger swath of Americans. Primarily wealthy and well-educated people apply new technologies at first now, he said, suggesting others lack the access and/or ability to use them. “I urge you to think beyond the hypothetical or artificial laboratory-based assessment of how new drugs, devices and foods will be used across our society,” he told the audience.