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 demonstrates that you have dense breast tissue, which could hide abnormalities. Dense breast tissue, in and of itself, is a relatively common condition. Therefore, this information is not provided to cause undue concern; rather, it is to raise your awareness and promote discussion with your health care provider regarding the presence of dense breast tissue in addition to other risk factors."

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.

Cite as R.C. § 3702.40

Added by 130th General Assembly File No. TBD, HB 394, §1, eff. 3/19/2015.