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Pathology in the Digital Era

by Mary Beth Nierengarten •

However, he highlighted one of the limitations of digital pathology specific to head and neck cases: the need to provide surgeons with a quick assessment of resection margins using frozen sections. “We have learned so far in our validation studies that there are a few problematic areas that seem more difficult to interpret,” he said. “Perhaps we just need practice, but our experience so far suggests that squamous dysplasia may be more difficult to classify from digital images compared to microscope slides.”

“Often, and specifically when looking at margins, one wants to know the extent of dysplasia occurring on the mucosa, and that seems to be difficult to interpret digitally,” he said.—MBN

FDA Regulation

For digital pathology systems to be used in FDA-regulated laboratories, safeguards need to be met to comply with the following FDA stipulations:

Proper storage of digital slides, metadata, and information such as annotations and analysis results to ensure data integrity for the duration of image retention, which is two to five years.

Data management processes must be in place that include responsibility for and access rights to the archive.

Data security and protection of all data including any archived electronic records. This will require the existence of time-stamped audits of any activity that creates, modifies, or deletes data from the archive.

Source: Digital Pathology Association