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# Few AI Breast Imaging Products Show Racial Demographics
- URL: https://www.fdaweb.com/few-ai-breast-imaging-products-show-racial-demographics/
- Published: 2021-02-11T12:00:00.000Z
- Updated: 2026-09-14T16:46:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148646

Only 10% of artificial intelligence (AI) products cleared by FDA for use in breast imaging provided a breakdown of racial demographics of the data used to validate the algorithm’s performance in public summaries filed by manufacturers. A *Stat* [analysis](https://www.statnews.com/2021/02/11/breast-cancer-disparities-artificial-intelligence-fda/?ref=fdaweb.com) says the remaining 90% only said that they have been tested on various numbers of scans from proprietary datasets or mostly unnamed institutions.

*Stat* says that FDA’s decision to clear products without requiring them to publicly disclose how extensively their tools have been tested on people of color “threatens to worsen already gaping disparities in outcomes within breast cancer, a disease that is 46% more likely to be fatal for Black women.”

“The data used to support AI products — first to train the system to learn and then to test and validate its performance — is a crucial marker of whether they are effective for a wide range of patients,” the post says. “But the companies often treat that information as proprietary, part of the secret recipe that sets their products apart from rivals in an increasingly competitive market.”

The post says FDA is still trying to draw the line between the commercial interest in confidentiality and the public interest in disclosure and whether it can, or should, force manufacturers to be fully transparent about their datasets to ensure AI algorithms are safe and effective.

“It’s an extremely important topic for us,” FDA Digital Health Center of Excellence director **Bakul Patel** told *Stat*. “We want to have that next level of conversation: What should that expectation be for people to bring trustworthiness in these products.”

While a 2017 guidance called on all makers of medical devices to publicly report on the demographics of populations used to study their products, *Stat* says that to date that level of detail is not being provided in public summaries of AI products posted to the agency Web site. So far, it reports, just seven of 161 AI products cleared in recent years include any information about the racial compensation of their datasets. Nonetheless, it says, the devices were cleared to use AI to help detect or diagnose a wide array of serious conditions, including heart disease, strokes, and respiratory illnesses.

Meanwhile, in a 1/25 [letter](https://www.fdaweb.com/senators-want-pulse-oximeter-info/), three senators asked FDA for information on pulse oximeter effectiveness when they are used for patients with darker skin, a second concern about FDA not paying sufficient attention to racial differences.