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May 9, 2019

New Federal Requirements to Inform Patients About Breast Density: Will They Help Patients?

Author Affiliations
  • 1Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts
  • 2Divisions of General Internal Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
  • 3Women’s Health, Brigham and Women’s Hospital, Boston, Massachusetts
JAMA. 2019;321(23):2275-2276. doi:10.1001/jama.2019.5919

As primary care physicians adapt to the challenge of individualizing breast cancer screening decisions, they now must also grapple with how to address breast density. Following 38 states and the District of Columbia that have adopted legislation requiring that women with dense breasts be notified about their breast density, on February 15, 2019, the US Congress passed national breast density legislation.1 Specifically, the law directed the US Food and Drug Administration (FDA), through the regulatory process, to ensure that all mammography reports and the lay summaries provided to patients include information about women’s’ breast density. Even before the 2019 Congressional legislation, the FDA, which has overseen the regulation of mammography facilities since enactment of the Mammography Quality Standards Act of 1992, was working to address communication about breast density in mammography reports, describing the absence of consistent information about breast density across states as a failure of regulation.2 On March 27, 2019, the FDA announced proposed amendments to the Mammography Quality Standards Act, including a proposed rule requiring breast density reporting by mammography facilities.3 This proposed rule is open for public comment until June 26, 2019.

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