The robot will see you now...

For today's patients those words still exist in science fiction, not reality. But soon AI could be coming to an examining room near you.

“I know there’s often a lot of hype around the promises of digital health,” FDA commissioner Dr. Scott Gottlieb said in his prepared remarks for the Academy Health’s 2018 Health Datapalooza held in Washington, D.C.

“But when it comes to digital health, from where I sit – and based on what we’re seeing at FDA – the long-run is now,” he advised.

He stressed new changes at the FDA aimed at making the most of the new surge of AI and digital health tools in the healthcare arena.

"AI holds enormous promise for the future of medicine," said Gottlieb, noting that the agency is “actively developing a new regulatory framework” to ease the path of innovations in the use of AI-based technologies.

An example, of the agency's new approach, he stated, is its pre-certification program for digital health companies, begun last year.

“We expect to see an increasing number of AI-based submissions in the coming years, starting with medical imaging devices, and we're working with experts in the field," he said.

The FDA, he advised, must keep pace with the rapid changes in healthcare.

The agency must become “as nimble and innovative” as what it regulates,” he stressed, advising, “that requires us to take modern and flexible approaches to regulation when it comes to highly novel areas like digital health.”

To address the pace of change, last summer, the agency launched its Digital Health Innovation Action Plan.

It outlines the efforts to “reimagine the FDA’s approach,” he said.

He also announced that the agency would encourage the use of digital health tools in drug development.

“As we begin for the first time to address the role of digital health in drug development, we’ll work to ensure our regulatory approach reflects the novel nature of these products and encourages and supports their innovation,” he advised, adding, “we must recognize the potential of digital health as a new tool to improve the safety and effectiveness of drug delivery.”

He cited a number of advances made possible by AI.

One winning FDA approval in April is the IDx-DR, a device that detects diabetic retinopathy, the most common cause of vision loss among the more than 30 million Americans living with diabetes.

Calling the decision "a historic moment that has the potential to launch a transformation in the way U.S. healthcare is delivered," Dr. Michael Abràmoff, founder and president of Idx noted in a company statement that, "autonomous AI systems have massive potential to improve healthcare productivity, lower healthcare costs, and improve accessibility and quality.”

The device pairs a camera with artificial intelligence, and is able to work so autonomously that it can be put into a primary care setting with no eye doctor.

In the future, Gottlieb suggested, AI could find its way into smartphones and wearables to cut the need for reliance on expensive specialists and office visits for many early detection concerns.

The push to AI is global. Just in early April, the first AI-based pathology diagnostic system began operating in a live clinical setting to assist in the confirmation of prostate cancer.

The Institute of Pathology at Maccabi Healthcare Services in Israel has deployed Ibex Medical Analytics’ Second Read (SR) System to identify various cell types and features within whole slide images of prostate core needle biopsies (PCNBs), including grading cancerous glands and other clinically significant features. Its use follows a pilot period in which it identified isolated major errors in retrospective PCNBs that were previously diagnosed as benign by pathologists.

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