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FDA's Robert Califf on AI in Healthcare: 'It's a Different World'

Analysis  |  By Eric Wicklund  
   January 11, 2024

As health system execs attending CES 2024 talked of using AI to address specific challenges, the FDA commissioner pointed out that the technology will fundamentally change how healthcare is delivered in the future.

Healthcare executives are in uncharted territory, due to the speed at which AI is evolving. And with that progress, health systems and the federal government are going to have to continually adjust how the technology is governed.

“The assessment of the algorithms needs to be continuous,” US Food and Drug Administration Commissioner Robert Califf, MD, told a packed room during a session Wednesday at the CES 2024 show in Las Vegas. In fact, he added, post-market evaluations of new tools may be more important than pre-market evaluations.

“It’s a different world,” the FDA commissioner added. “The changes are dramatic. … We can see the time when [healthcare] is going to be guided and assisted so much more by algorithms and AI.”

As the massive consumer technology show continues this week, AI is dominating the many exhibit halls and the discussion around the two-day Digital Health Summit, which runs through today. Aside from getting a glimpse at new advances in smart health technology—from smart toilets and bathrooms to smart beds and pillows to more refined wearables and sensors—healthcare execs who braved the typical Las Vegas chaos talked of how AI is already being used to address key pain points like administrative overload, stressed out providers, and siloed care.

“This stuff is so powerful,” Lee Schwamm, MD, chief digital health officer at the Yale New Haven Health System and associate dean of digital strategy and transformation at the Yale School of Medicine, offered during a panel discussion. “Health systems are just now trying to figure out what the business model will be.”

Sara Vaezy, EVP and chief strategy and digital health at Providence and a panelist at the upcoming HealthLeaders AI NOW Virtual Summit later this month, said her health system is working on four distinct AI demonstration projects in a partnership with Microsoft, primarily around automating tasks that affect the clinician workload and improving self-service options for patients.

“It’s just too expensive to deliver care in the way that we normally have,” she said.

Both she and Schwamm pointed out that the use of AI in healthcare will be different than in other industries, primarily because of the inclusion of patient data. Health systems and hospitals need to plan carefully to protect that information, since so much of AI depends on using data to make decisions and advance processes.

“This is a very special space,” Schwamm pointed out.

Califf, whose appearance at CES was as part of the government and policy track, also pointed out the intricacies of healthcare. He noted the industry is gradually shifting from episodic to value-based care, where not just immediate outcomes but long-term outcomes are valued.

“In order to make it work you’ve got to [focus on] complete outcomes,” he said.

Califf said he’s excited about how AI will factor into healthcare in three distinct venues: The home, where more care is being delivered and more patient data is being collected; the operating room, where robotics and digital health are changing how surgical procedures are done; and the clinic, where providers are learning how to use technology to develop care management and coordination plans that surround the patient and become part of his or her journey.

He also noted the advance of wearables, which are becoming more sophisticated, and the rapid pace of development for adaptive AI models such as ChatGPT.

“The chance to learn through algorithms is the basis for so many things we take for granted in life,” he said.

Eric Wicklund is the associate content manager and senior editor for Innovation, Technology, and Pharma for HealthLeaders.


FDA Commissioner Robert Califf, MD, told CES attendees on Wednesday that AI needs to be assessed continuously, and that the industry and government need to adapt alongside the technology.

Health system executives including Sara Vaezy of Providence and Lee Schwamm, MD, of Yale New Haven Health pointed out that AI can help address the industry’s biggest problems, but they have to be careful to protect patient data.

Health system leadership developing an AI strategy should look at how the technology affects three areas of care delivery: The home, the OR, and the clinic.

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