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GLOSSARY OF TERMS

1. CLINICAL USE: The use of digital pathology within the diagnostic practice of human pathology and for the diagnosis and treatment of patients.

2. DICOM: Digital Imaging and Communications in Medicine (DICOM) as defined by NEMA is the international standard for medical images and related information (ISO 12052). DICOM facilitates interoperability of medical imaging equipment; specifically the exchange of information between medical imaging equipment and other systems (ie. PACS, EMR, APLIS, etc).

3. DIGITAL PATHOLOGY: A dynamic, image-based environment that enables the acquisition, management and interpretation of pathology information generated from a digitized glass slide.  Often used interchangeably with “Virtual Microscopy.”

4. DIGITAL PATHOLOGY SYSTEM (DPS): An image-based computer system that enables the acquisition, management and interpretation of pathology information generated from a digitized glass slide.

5. IMAGE ANALYSIS: Defined by the College of American Pathologists as computer-assisted detection or quantification of specific features in an image following enhancement and processing of the image, including DNA analysis, morphometric analysis and FISH.

6. LABORATORY DEVELOPED TEST (LDT): A test developed within a clinical laboratory that has both of the following characteristics: is performed by the clinical laboratory in which the test was developed and is neither FDA cleared nor FDA approved.

7. MIDDLEWARE: Middleware software connects software components or applications and consists of a set of services that allows multiple processes running on one or more platform to interact and communicate. This type of software evolved to provide interoperability.

8. NONCLINICAL ENVIRONMENT: A nonclinical laboratory, which conducts in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals.

9. TELEPATHOLOGY: Defined by the American Telemedicine Association as electronic, multimedia communication between pathologists for the purpose of primary diagnoses and diagnostic consultation second opinion.

10. VALIDATION: An ongoing process to establish documented evidence that provides a high degree of assurance, that a process or system will consistently perform according to predetermined specifications and quality attributes.

11. VIRTUAL MICROSCOPY: Virtual microscopy enables viewing of microscope slides on a computer screen over a network;  Equivalent optical resolution and visual magnification of a microscope is maintained, as well as scanning, zooming (change of magnification), and focus. Often used interchangeably with “Digital Pathology.”

12. VIRTUAL SLIDE: A digitized histopathology glass slide that has been created on a slide scanner.  The digitized glass slide represents a high-resolution replica of the original glass that can then be manipulated through software to mimic microscope review and diagnosis. Also referred to as a Whole Slide Image (WSI).

13. WHOLE SLIDE IMAGE (WSI): A digitized histopathology glass slide that has been created on a slide scanner.  The digitized glass slide represents a high-resolution replica of the original glass that can then be manipulated through software to mimic microscope review and diagnosis. Also referred to as a virtual slide.

14. WHOLE SLIDE IMAGING: The acquisition process of creating a virtual slide or whole slide image on a slide scanner.

15. WHOLE SLIDE SCANNER (WSS): The hardware and associated software required to generate a whole slide image.