Abstract
Digital pathology systems are powerful tools which have great potential to aid the practice of toxicologic pathology. Currently, the use of these systems varies from a very simple process (acquisition of an image to share with a colleague) to more complex processes (acquisition of images to aid automated image analysis). In the regulatory setting, there remains considerable uncertainty regarding the appropriate use of digital pathology systems. One important aspect of any system used in a regulatory setting is the need for appropriate validation procedures. Recognizing the need for guidance in this area, the Digital Pathology Association (DPA) prepared a white paper that would provide a technical overview of factors to consider in the validation of these systems. The DPA is an organization formed to facilitate education and awareness of digital pathology applications in health care and life sciences. Recognizing the important role of the pathologist in this process, the DPA approached the Society of Toxicologic Pathology (STP) and requested input on the draft position paper.
The STP’s Scientific and Regulatory Policy Committee and Executive Committee reviewed the draft document and provided comments, which the DPA has incorporated in this published version. Importantly, the society assessed whether there were any practices suggested in the DPA paper that conflicted with principles articulated in STP positions on pathology image data such as Tuomari et al. (2007). Because the DPA paper focuses on technical aspects of how to validate a system, rather than on when validation is needed, the STP determined the DPA paper was not in conflict with current STP positions. The society encouraged the DPA to consider publishing the paper in Toxicologic Pathology, rather than limiting publication to the DPA website. We appreciate the DPA’s efforts on this important topic and their collaboration on bringing the paper to publication in the journal. We hope the readership of Toxicologic Pathology will find the paper a useful reference.