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# Change FDA AI Policies: Gottlieb
- URL: https://www.fdaweb.com/change-fda-ai-policies-gottlieb/
- Published: 2025-02-11T12:00:00.000Z
- Updated: 2026-09-14T14:52:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158636

Former FDA commissioner **Scott Gottlieb**, now an American Enterprise Institute senior fellow, cautions that a high-value application of artificial intelligence (AI) and artificial general intelligence (AGI) in medicine hinges on their seamless integration into an electronic medical record (EMR), accessing and synthesizing diverse data. He says current FDA policies may make such integration difficult, limiting the usefulness of AI and AGI.

Writing in a *JAMA Health Forum* [column](https://jamanetwork.com/journals/jama-health-forum/fullarticle/2830189?ref=fdaweb.com), Gottlieb defines AGI as “a revolutionary form of AI capable of understanding, learning, and applying knowledge across various tasks with human-like proficiency.”

He writes that during his 2017-2019 tenure as FDA commissioner, the agency issued policies on using clinical decision support software (CDSS) within the context of the increasingly sophisticated capabilities of the tools. “The guidance stipulated that CDSS tools that explain their recommendations or provide information to clinicians without making explicit treatment recommendations would fall outside FDA’s regulation,” he says.

New agency guidance issued in 9/2022 tightened the criteria for CDSS exemptions from premarket review as medical devices, Gottlieb says. He expresses concern that considerations the updated guidance was intended to address could mean that any AI functionality that is integrated into an EMR could fall outside the initial exemption and render the new tool, and perhaps even the whole EMR, a medical device subject to premarket review.

He says that a solution lies in returning to the intent of the 21st Century Cures Act and the guidance issued during his tenure. “The intent was to regulate CDSS based on how the data analysis is presented to healthcare clinicians instead of focusing on how clinicians would use the information to inform their judgment,” he writes. “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 subject to premarket review. 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. Then, by drawing on real-world evidence of these systems in action in the postmarket setting, the agency can verify that they genuinely enhance the quality of medical decision-making.”