API Working Group Session – Open Discussion of Pathology Digital Imaging Standards Organizers: Jules J. Berman, Ph.D., M.D. Program Director for Pathology Informatics, CDP/NCI Ulysses J. Balis, M.D. Director of Pathology Informatics, Mass General Hospital APIII, Pittsburgh, PA, Wednesday, Oct 6, 2004

Review of past year’s Activities At last year’s API workshop, organized by Drs. Ul Balis and Bruce Beckwith, there was enthusiasm for creating an XML- based pathology image specification that would be compatible with DICOM (a standard popular with radiologists but completely ignored by lab image vendors)

Under the leadership of Bruce Friedman, an API initiative in the realm of pathology imaging was approved by the API Council. This initiative is the Laboratory Digital Imaging Project (LDIP)

The major work-project within LDIP would be the creation of an XML-based pathology image specification. The specification will be created with talent from a specific LDIP task committee composed of API members, vendors and interested experts in the field of imaging and/or standards.

This project will be the chief responsibility of the API Research Committee, and will be first-chaired by Jules Berman (current chair of the API Research Committee). Serving in an advisory capacity will be Robert Miller, chairman of the Technical Standards Committee and Ul Balis, chairman of the Training and Education Committee and the members of their respective committees. A mechanism for funding this effort was developed by Dr. Bruce Friedman.

A charter for the LDIP image specification effort was created and approved by the API Council. The current purpose of the project is to develop an open exchange specification in XML as a common file structure allowing users to annotate images with defined data elements. Images described by the new annotation will permit vendors to port proprietary image files to and from an open exchange specification. It will also allow users to publish or share their files with other users independently of vendor application.

The specific properties of the exchange specification will relate to the following: 1. General file properties, such as who created the file, when the file was created, the purpose of the file, and any intellectual property rights and restrictions. This section may contain data elements that authenticate the file or its creator, and ensures the approved IRB/Privacy Board status of the file.

The specific properties of the exchange specification will relate to the following: 2. Binary object properties, such as the organization, structure or mathematical properties of the binary image(s), so-called image header data, technical image or image display descriptors, and either the binary object itself (rendered in ascii base64) or with a pointer to a URL holding the binary image file.

The specific properties of the exchange specification will relate to the following: 3. Image capture device information, specifying the microscope/camera and any other hardware devices contributing to the capture of the image.

The specific properties of the exchange specification will relate to the following: 4. Image acquisition information, such as device settings and physico/optical parameters related to the capture of the image, and calibration data or protocols.

The specific properties of the exchange specification will relate to the following: 5. Histologic features, such as staining information, or pointers to experimental protocols for the preparation of the image.

The specific properties of the exchange specification will relate to the following: 6. Specimen information, which may include the methods used to procure or prepare the specimen and pointers to specific specimen-related records in tissue databases or specimen repositories.

The specific properties of the exchange specification will relate to the following: 7. Pathologic information pertaining to the image, including diagnosis, or specific pathologic descriptions of defined regions of interest.

The specific properties of the exchange specification will relate to the following: 8. Clinical or demographic information related to the patient providing the specimen. This section can be provided with de- identified or encrypted data elements or with data intended to authenticate or otherwise ensure the confidentiality, privacy of the record or ensure compliance with federal regulations.

Current members of the LDIP image specification committee (please tell me if I forgot you) John Ainsworth Ulysses Balis Steve Barbee Jeffrey Beckstead Bruce Beckwith Jules Berman James Crawford Bruce Friedman Walter Henricks Keith Kaplan Mark Newberger Steve Schwartz Mark Tuthill Bruce Williams Gretchen Bretsch Mark Sobel Ole Eichhorn Alton D. Floyd Kemp Watson John Stinson

Open Workshops: We intend to have two open workshops each year to review progress by the task committee. One will be held at the annual APIII meeting in Pittsburgh (usually end of September or early October) The other will be held at the annual Lab InfoTech Summit in Las Vegas (usually in early March). We expect this work to require 3-5 years to create the specification, followed by an extended period for modifications

Purpose of the Open Workshops To review committee progress To discuss any concerns/interests of the intended user community To solicit assistance (developers, testers, implementers, representatives from related standards efforts)

Purpose of today’s Open Workshop To get an idea of who is here (primary purpose today) To permit people to comment on the process that we’re proposing To hear about any related activities (particularly with regard to the OME - Open Microscopy Environment) To start dividing the effort into preliminary activities (for assignment within the committee)

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