The U.S. Food and Drug Administration (FDA) is working on a new regulatory framework aimed at encouraging the use of artificial intelligence (AI) in healthcare, according to a report from the Hill.
In prepared comments on April 26 at the Health Datapalooza conference in Washington, DC, FDA Commissioner Dr. Scott Gottlieb said that the updated framework would allow regulators to keep up with new technology and promote innovation in this space, according to the article.
"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.
Gottlieb noted that the FDA is working with experts to update the way the agency evaluates these new technologies during the approval process.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
