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Currently, a summary of a mammography center’s written report must be sent directly to the patient and must be written in terms easily understood by a layperson. This summary is sent as a result of the U.S. Food and Drug Administration’s (FDA) Mammography Quality Standards Act (MQSA) (Public Law 102-539). Right now, there is no federal law or regulation requiring that summary, or the report sent to the patient's referring health provider, to include information about a patient’s breast density. To create a national standard so that all women and their referring health providers receive notification of breast density, an MQSA reporting amendment is needed.


Creating and enacting federal laws through the U.S. Congress is referred to as the “legislative” process, while creating and enacting regulations, which are equally enforceable, is generally referred to as the "rulemaking" process. Congress passes a law designed to address a social or economic need or problem. The appropriate regulatory agency then creates regulations necessary to implement the law.

An MQSA amendment can be accomplished either through federal legislation or federal regulation, and advocacy efforts have been initiated on both fronts.

Federal Legislation: The Breast Density and Mammography Reporting Act of 2017 has been  introduced into both the U.S. House of Representatives (H.R. 4122) and U.S. Senate (S. 2006). The Act outlines that mammography reports include information about breast density and “convey the effect of breast density in masking the presence of breast cancer on mammography...” It additionally enhances research relating to breast density.  Many existing state breast density inform laws meet or surpass the scope of information in this proposed legislation. Unless federal requirements are more stringent than state laws, the state laws will continue to be effective. 

Federal Regulation: A national density inform standard could also be achieved if a bill does not progress through Congress through a regulatory amendment to the MQSA reporting requirements. The FDA, which oversees the MQSA program, anticipates publishing proposed amendments to the MQSA regulations for notice and comment. Among other things, the proposed amendments are expected to address breast density reporting. Any proposed language that might be contained in such a reporting requirement will become public at that time.

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