The U.S. Food and Drug Administration (FDA) has updated its mammography regulations to require reporting of breast density information by facilities, according to a March 9 statement by the administration. The update is a significant step towards empowering patients to take control of their breast health by providing them with crucial information about their mammogram results.

Breast density is a known risk factor for breast cancer, as conventional screening mammography may struggle to detect suspicious lesions in dense breast tissue. However, many patients are not aware of this risk. Some states have taken steps to address this information gap, although state-level regulations vary widely in terms of the requirements to notify patients of this risk factor.

The new regulations will require facilities to notify patients about the density of their breasts, allowing them to understand how density may influence the accuracy of their mammogram. The FDA’s move to require breast density reporting by facilities is a huge step in improving access to information about breast health. About half of patients over age 40 in the U.S. have dense breast tissue, and the FDA’s requirement ensures that all who have a mammogram will be informed of their breast density and the potential implications.

The FDA has been working since 1992 to ensure patients have access to quality mammography, and the impact of the Mammography Quality Standards Act law on public health has been significant, including a decrease in the number of facilities that do not meet quality standards. In addition to improving access to information about breast density, the new regulations will also “strengthen the FDA’s oversight and enforcement” of imaging providers, making it easier for radiologists to categorize and assess mammograms. This will improve the accuracy of mammogram results, leading to better cancer detection rates and potentially earlier treatment.

The final rule published 3/10/2023 allows 18 months for the rule to be implemented.

As always, ADVOCATE will keep you up to date on this and other issues impacting medical groups as they become available.

Kayley Jaquet

Manager, Regulatory Affairs