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Information for mammography facility personnel, inspectors, and consumers               about the implementation of the Mammography Quality Standards Act of 1992 (MQSA)

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Welcome to FDA's Mammography Program within the Center for Devices and Radiological Health. This website is designed to inform mammography facility personnel, inspectors, and other interested individuals about the implementation of the Mammography Quality Standards Act of 1992 (MQSA).

On June 1, 2004, the Office of Health and Industry Programs (OHIP) which houses the Division of Mammography Quality and Radiation Programs (DMQRP) was officially renamed the Office of Communication, Education, and Radiation Programs (OCER).

About Mammography Quality Standards Act (MQSA)

Congress enacted MQSA to ensure that all women have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages. In the fall of 2004, Congress reauthorized MQSA, extending the program to 2007. The Act refers to the MQSA as amended by the Mammography Quality Standards Reauthorization Acts of 1998 and 2004 (MQSRA).

Congress charged FDA with developing and implementing MQSA regulations. Interim regulations, issued in December 1993, became effective in February 1994. In 1995, FDA began enforcing MQSA when it initiated an inspection program. On October 28, 1997, FDA issued more comprehensive final regulations, which became effective on April 28, 1999. Three amendments to the regulations have been published since they were first issued. These amendments have been incorporated in the amended final regulations.

Information on Approved Alternative Requirements is also available.

HIPAA and release of information for MQSA purposes

Implementation of the Health Insurance Portability and Accountability Act (HIPAA) has raised a number of issues with respect to mammography facilities that operate under the Mammography Quality Standards Act (MQSA). Two issues are arising with increasing frequency. The first concerns the protection of patient information during MQSA inspections. The second deals with whether other medical entities (e.g., referring physicians, pathology departments, surgeons) can release patient biopsy information to mammography facilities for purposes of the MQSA medical outcomes audit without obtaining patient authorization. The HIPAA regulations address these matters as follows:

Regarding the first issue, sections 164.512(b) and (d) of the HIPAA regulations allow a mammography facility to release patient information to an MQSA inspector without patient authorization because MQSA inspectors are performing health oversight activities required by law.

As to the second issue, section 164.512(b) of the HIPAA regulations allows a covered entity (e.g., referring physician, pathology department, surgeon) to release patient biopsy information to a mammography facility for purposes of the MQSA medical outcomes audit without patient authorization because the disclosure : (1) is to "a person subject to FDA jurisdiction;" (2) concerns an FDA-regulated product or activity for which the mammography facility has responsibility; and (3) relates to the quality, safety or effectiveness of the product or activity.

If you have a specific question about the regulations, please go directly to the Policy Guidance Help System. This is an information resource that looks like a Windows help system.

Updated July 21, 2004

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