Section 3702.40 - Mammogram report; dense breast tissue advisory(A) As used in this section, "mammogram" and "facility" have the same meanings as in section 263b(a) of the "Mammography Quality Standards Act of 1992," 106 Stat. 3547 (1992), 42 U.S.C. 263b (a), as amended.(B) As required by 21 C.F.R. 900.12 (c)(2), a facility shall send to each patient who has a mammogram at the facility a summary of the written report containing the results of the patient's mammogram. If, based on the breast imaging reporting and data system established by the American college of radiology, the patient's mammogram demonstrates that the patient has dense breast tissue, the summary shall include the following statement: "Your mammogram shows that your breast tissueis dense. Dense breast tissue is very common and is not abnormal. However, dense breast tissue can make it harder to find cancer on a mammogram and also may increase your risk of developing breast cancer. Because you have dense breast tissue, you could benefit from additional imaging tests such as a screening breast ultrasound or breast magnetic resonance imaging. This information about your breast density is being provided to you to raise your awareness. It is important to continue routine screening mammograms and use this information to speak with your health care provider about your own risk for breast cancer. At that time, ask your health care provider if more screening tests might be useful based on your risk. A report of your mammogram results was sent to your health care provider."
As required by 21 C.F.R. 900.12 (c)(3), the facility shall send to the patient's health care provider, if known, a copy of the written report containing the results of the patient's mammogram not later than thirty days after the mammogram was performed.
(C) This section does not do either of the following: (1) Create a new cause of action or substantive legal right against a person, facility, or other entity;(2) Create a standard of care, obligation, or duty for a person, facility, or other entity that would provide the basis for a cause of action or substantive legal right, other than the duty to send the summary and written report described in division (B) of this section.Amended by 134th General Assembly, HB 371,§1, eff. 9/23/2022.Added by 130th General Assembly, HB 394,§1, eff. 3/19/2015.