Doctors, scientists and economists

Scott Gottlieb

U.S. Food and Drug Administration commissioner, 2017–2019

3 records

Portrait source: United States Government, Public domain

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But there’s a great deal of promise beyond locked algorithms that’s ripe for application in the health care space, and which requires careful oversight to ensure the benefits of these advanced technologies outweigh the risks to patients.

Scott Gottlieb

U.S. Food and Drug Administration commissioner, 2017–2019

In a 2019 FDA statement, Scott Gottlieb said adaptive medical AI required careful oversight so its benefits would outweigh risks to patients.

FDA commissionerApril 2, 2019U.S. Food and Drug Administration

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These locked algorithms are modified by the manufacturer at intervals, which includes “training” of the algorithm using new data, followed by manual verification and validation of the updated algorithm. But there’s a great deal of promise beyond locked algorithms that’s ripe for application in the health care space, and which requires careful oversight to ensure the benefits of these advanced technologies outweigh the risks to patients. These machine learning algorithms that continually evolve, often called “adaptive” or “continuously learning” algorithms, don’t need manual modification to incorporate learning or updates.

What this quote does not say

In the same statement, Gottlieb said AI could have a profound positive impact on health care and sought oversight that would allow beneficial and innovative software to reach the market while maintaining safety.

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If these AI tools are designed to augment the information available to clinicians and do not provide autonomous diagnoses or treatment decisions, they should not be subjected to premarket review.

Scott Gottlieb

U.S. Food and Drug Administration commissioner, 2017–2019

In a 2025 article, Scott Gottlieb wrote that AI tools assisting clinicians without making autonomous diagnoses or treatment decisions should not undergo premarket FDA review.

Former FDA commissionerPublished February 10, 2025 · date of remarks not establishedAmerican Enterprise Institute Center for Technology, Science, and Energy

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The intent was to regulate CDSS based on how the data analysis is presented to health care clinicians instead of focusing on how clinicians would use the information to inform their judgment. If these AI tools are designed to augment the information available to clinicians and do not provide autonomous diagnoses or treatment decisions, they should not be subjected to premarket review. The FDA could allow EMR providers to come to market with these tools as long as they meet FDA criteria for how they are designed and validated.

What this quote does not say

Gottlieb immediately added that FDA could still require design and validation criteria and assess real-world postmarket evidence.

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We’re considering how an approach that enables the evaluation and monitoring of a software product from its premarket development to post-market performance could provide reasonable assurance of safety and effectiveness and allow the FDA’s regulatory oversight to embrace the iterative nature of these artificial intelligence products while ensuring that our standards for safety and effectiveness are maintained.

Scott Gottlieb

U.S. Food and Drug Administration commissioner, 2017–2019

In a 2019 FDA statement, Scott Gottlieb said the agency was considering lifecycle evaluation and monitoring for medical AI to accommodate updates while maintaining safety standards.

FDA commissionerApril 2, 2019U.S. Food and Drug Administration

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Our ideas are the foundational first step to developing a total product lifecycle approach to regulating these algorithms that use real-world data to adapt and improve. We’re considering how an approach that enables the evaluation and monitoring of a software product from its premarket development to post-market performance could provide reasonable assurance of safety and effectiveness and allow the FDA’s regulatory oversight to embrace the iterative nature of these artificial intelligence products while ensuring that our standards for safety and effectiveness are maintained. This first step in developing our approach outlines information specific to devices that include artificial intelligence algorithms that make real-world modifications that the agency might require for premarket review.

What this quote does not say

This was an approach under consideration, not a final FDA framework; the statement says further guidance would follow public feedback.
Gottlieb said the approach was intended to enable beneficial and innovative AI software to reach the market while keeping safety and effectiveness standards.

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