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Former FDA Head Scott Gottlieb to Headline Upcoming AIHD Conference

Companies bringing artificial intelligence (AI) to providers will gain key insights about the market opportunities to improve patient care and generate more revenue when they hear from former Food and Drug Administration (FDA) Commissioner Scott Gottlieb, who was announced this week as a keynote speaker at the Artificial Intelligence in Healthcare and Diagnostics (AIHD) Conference. The event takes place May 10-11 in San Jose, Calif.

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AI in healthcare is less about replacing the duties of providers and more about analyzing the troves of data in clinical records to support better care decisions. That notion has long been advocated by Gottlieb, who helped the FDA develop its guidelines for evaluating AI for use in clinical care settings.

“I don’t think artificial intelligence and the use of algorithms to help assess things like histopathology or radiological scans is going to replace the radiologists,” Gottlieb said during a 2021 webinar hosted by Proscia, which develops AI-powered pathology software. “There’s always going to be radiologists. There’s always going to be pathologists. I think the technology is going to provide assistance to annotate data, helping to make a diagnosis.”

AIHD Conference Focuses on the State of AI in Healthcare

At AIHD, Gottlieb will engage in a fireside chat and then take part in a panel discussion with other keynote speakers.

“We are producing AIHD in Silicon Valley because that’s the hotbed for AI technology. It’s a great location to assess how artificial intelligence is being used to support healthcare,” said Robert Michel, founder of AIHD and Executive Director of the Precision Medicine Institute. Michel will moderate the fireside chat with Gottlieb.

“There’s no better individual than Dr. Gottlieb to address AIHD participants about the state of artificial intelligence, where it’s going, how it’s regulatory oversight will unfold, and what’s likely to be the most surprising contribution of AI in patient care,” Michel added.

Executives attending the conference will walk away with strategic lessons about how AI will influence:

  • Healthcare diagnostics in areas such as digital pathology;
  • Drug discovery and development; and,
  • Precision medicine’s goal to deliver more personalized treatments for patients.

“Dr. Gottlieb is looking forward to addressing industry leaders who represent the scientific expertise developing AI and the emerging companies that are delivering AI-powered services to hospitals and physicians,” Michel noted.

Under Gottlieb, FDA Established New AI Review Framework

Gottlieb served as FDA Commissioner from 2017 to 2019. During that time, he promoted a framework to regulate AI within medical devices that attempted to balance innovation with patient safety needs.

 

“More and more data devices are getting breakthrough designation,” he said during the Proscia webinar. “One of the last things I did before I left the agency was make sure that we got out the AI blueprint that we put together.”

 

Gottlieb valued two pillar tenets as part of the FDA framework for AI devices:

  • As true AI learns from data, there must be middle ground that allows the software to make mistakes in its learning while also ensuring any tool does not become less predictive as it evolves.
  • If an AI developer uses its own careful validation process for products, then the FDA should evaluate the company’s process rather than individual devices produced by the company—a stance known as “regulating the firm.”

“Why do we need to rip apart the tool and the software if the process is pristine?” Gottlieb commented.

 

Since leaving the FDA, Gottlieb has been a frequent media commentator about the COVID-19 pandemic. He is a senior fellow at the American Enterprise Institute, a public policy research institute. He is also partner at venture capital firm New Enterprise Associates and serves on the boards of Pfizer and Illumina.

 

—Scott Wallask

Related Resources:

Artificial Intelligence in Healthcare and Diagnostics Conference

Future Ready Pathology from Proscia

Watch for These Three AI Trends in Healthcare, Says Expert Speaker at Upcoming AIHD Conference

FDA’s Breakthrough Devices Program