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U.S. Department of Health and Human Services

Radiation-Emitting Products

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With the introduction of Full Field Digital Mammography, what constitutes a mammogram for retention and transfer purposes, the digital data or the hardcopy film?

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There are two sections of the recordkeeping requirement that are affected by the introduction of full field digital mammography (FFDM). The first deals with retention of the mammography films. For purposes of film retention, the facility must maintain, in retrievable form, either the original or lossless compressed full field digital data or hardcopy films of final interpretation quality for the time periods specified in the above regulation. The second section affected by FFDM deals with transferring films. For purposes of transferring films, the facility must be able to provide the medical institution, physician, healthcare provider, patient or patient’s representative, with hardcopy films of final interpretation quality or, when it is acceptable to the recipient (e.g., a transfer between two FFDM facilities), with original or lossless compressed full field digital images electronically.

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