FDA commissioner says agency cannot be the only regulator of AI in digital health

FDA commissioner says agency cannot be the only regulator of AI in digital health Ngai Yeung

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The FDA cannot regulate the use of AI in digital health by itself, FDA commissioner Robert Califf said today at the Consumer Electronics Show in Las Vegas.

Instead, the FDA must rely on a committee of experts who evaluate AI algorithms, Califf said, comparing the adoption of AI in digital health to the beginning of a tidal wave or a tsunami.

“None of us know where this is going, it’s an explosive technology,” he said. “We got to have a community of entities that do the assessments in a way that gives us certification that the algorithms are actually doing good and not harm.”

Last fall, the FDA launched a new advisory committee to review issues in digital health, including the regulation of AI-enabled devices and more transparency for algorithms.

Califf, who used to head medical strategy at Alphabet, contributing to subsidiaries Verily Life Sciences and Google Health, said in his experience much of the digital world is built on immediate experience. But that’s dangerous in healthcare, where things that feel good in the moment may have adverse effects in the long term.

“Testing these algorithms is not a matter of how do they work today, it’s one of the health outcomes that occur over time,” he said.

The FDA is also responsible for educating the public about AI in health tech even as it learns along the way, Califf said.

“There’s a lot at stake as to whether we can develop societal accountability for this,” he said. “I just urge people to think what feels good immediately or may even look good immediately in health can turn out to be very adverse in the long term.”

Within the gamut of digital health, Califf is most excited about home care devices, robots and tech that can carry out surgeries anywhere in the world, and tech that can save clinicians time, such as automation for medical billing.

“The big issue was how do we make those available in a way that’s reliable and that builds trust in the population about the way they’re used,” he said. “That is a huge part of what FDA has to play a role in.”