Transfer of Digital Image Records

Citation:

900.12(c)(4)(ii),(iii): Each facility that performs mammograms:

(ii)  Shall upon request by, or on behalf of, the patient, permanently or temporarily transfer the original mammograms and copies of the patient's reports to a medical institution, or to a physician or health care provider of the patient, or to the patient directly;

(iii)  Any fee charged to the patients for providing the services in paragraph (c)(4)(ii) of this section shall not exceed the documented costs associated with this service.

Question 4: With the introduction of Full Field Digital Mammography, what constitutes a mammogram for retention and transfer purposes, the digital data or the hardcopy film?

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.

Question 5: We have an FFDM unit and do not keep hardcopy of our exams (i.e., we retain the images electronically). When patients request the release of their exam, we create a hardcopy for them. May we charge the patient for the cost of creating the hardcopy?

The facility may not charge for creating the first hardcopy version of the mammogram. However, if the patient requests one or more additional hard copies of the mammogram, the facility may pass the costs of the additional hardcopies on to the patient. 

Question 6: Can a facility use lossless compression to transmit images to the patient or other medical institutions for final interpretation?

Yes, provided that such transmission is acceptable to the receiving party. Lossless compression accurately preserves all of the data from the original mammogram and therefore FDA permits images regenerated from lossless compressed data to be used in the same manner as the original mammogram. 

Question 7: Can a facility use lossy compression to transmit images to the patient or other medical institutions for final interpretation?

No. Currently FDA does not permit images regenerated from lossy compressed data to be used in the same manner as the original mammogram.

While not allowed for final interpretation, lossy compressed images of previously obtained mammograms may be transferred to the patient or another medical institution to be used for comparison purposes if the interpreting physician deems that acceptable.

However, we recommend that if lossy compressed images are used for comparison purposes that only algorithms approved or cleared by FDA’s Office of Device Evaluation for such purposes be used. In addition, we recommend that phantom and clinical images produced by lossy compression pass all applicable quality control tests and be of such quality that if they were submitted, they would pass the facility’s accreditation body’s phantom and clinical image review process.

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