Integrating the Healthcare Enterprise

1. Integrating the Healthcare Enterprise Teaching File and Clinical Trial Export John Perry Fujifilm Medical Systems IHE Planning Committee IHE Interoperability Workshop

2. Teaching File and Clinical Trial ExportTCE • Teaching files are vital tools in medical education • Many institutions participate in clinical trials • TCE provides a simple, DICOM-based mechanism for connecting clinical systems to external teaching file or clinical trial systems • One implementation: two key features requested by almost every educational institution IHE Interoperability Workshop

3. Teaching File and Clinical Trial ExportExample Teaching File Scenario • A radiologist is viewing images for primariy diagnosis on an Image Display grouped with an Export Selector. The Export Selector allows images, series and studies to be selected “For Teaching File Export”. • The Export Selector may also provide a UI allowing the user to enter text notes and to select additional items (SR, KIN, GSPS, etc.) for inclusion in the exported objects. IHE Interoperability Workshop

4. Teaching File and Clinical Trial ExportExample Teaching File Scenario • The user action triggers the Export Selector to send the objects and a KIN manifest to the Export Manager. The Document Title of the KIN specifies “For Teaching File Export”. • The Export Manager collects all the objects selected and sends them to the Receiver which may be part of a Teaching File system. • The TF system receives the objects and the manifest and stores them for later use by the radiologist while authoring the teaching file case. • …other scenarios are in the Technical Framework IHE Interoperability Workshop

5. Teaching File and Clinical Trial ExportExample Clinical Trial Scenario • A clinical trial administrator at an acquisition site is viewing images on an Image Display or Acquisition Modality grouped with an Export Selector. The Export Selector allows images, series and studies to be selected “For Clinical Trial Export”. • The user action triggers the Export Selector to send images and a KIN manifest to the Export Manager. The Document Title of the KIN specifies “For Clinical Trial Export”. • There may be multiple trials in progress, and a single patient may be a participant in more than one trial. To allow the user to identify the clinical trial for which the images are intended, a free text field or a pre-configured pull down list is provided, which is encoded as the disposition in the text value of the KIN. IHE Interoperability Workshop

6. Teaching File and Clinical Trial ExportExample Clinical Trial Scenario • The Export Manager collects all the objects selected and sends them to the Receiver which may be part of a Clinical Trial communication system. • The CT system receives the objects and the manifest and forwards the relevant data to the central facility of the Clinical Trial. • …other scenarios are in the Technical Framework IHE Interoperability Workshop

7. Teaching File and Clinical Trial ExportValue Proposition • MIRC • Teaching File and Clinical Trial system • Developed, supported and promoted by the RSNA • Selected by the NCI for clinical trial image transport • Free & open source • Acts as a TCE Receiver • Supported by other CT and TF systems • You can add TF and CT capability to your products just by implementing the CTE profile IHE Interoperability Workshop

8. Teaching File and Clinical Trial Export • Export Selector • a system that identifies information to be sent to a teaching file or clinical trial system • example: a user at a PACS diagnostic workstation • Export Manager • de-identifies and re-identifies the image, reports, evidence documents, presentation states and additional information with pseudonymous values • supports the Remap Identifiers option to pseudonymize the images with the trial-specific identifiers and to populate the clinical trial specific attributes. • sends the pseudonymized DICOM objects and an updated manifest to a Receiver. • Receiver • a local teaching file or clinical trial system • a clinical trial system responsible for transferring images to the central review facility IHE Interoperability Workshop

9. Teaching File and Clinical Trial Export Export Selector Image Display Evidence Creator Report Creator Acquisition Modality Store Instances [Rad 50] Store Export Selection [Rad 51] Store Additional teaching File Information [Rad 52] Export Manager Image Manager/ Archive Report Manager Report Repository Export Instances [Rad 53] Receiver Image Archive/ Manager Portable Media Creator IHE Interoperability Workshop

10. Teaching File and Clinical Trial Export Export Selector Export Manager Receiver Store Instances [Rad 50] Store Export Selection [Rad 51] Store Additional TF Info [Rad 52] Delay for pathology De-identify attributes De-identify pixel data Re-map identifiers Export Instances [Rad 53] IHE Interoperability Workshop

11. Teaching File and Clinical Trial ExportExport Selection • Key Image Note used as a manifest of exported objects: • List of images and other DICOM objects • Coded Document Title “For Clinical Trial Export” • Text “disposition” • Information about the requesting user • Sent via conventional C-STORE • Not a new SOP Class IHE Interoperability Workshop

12. IHE Web site: http://www.ihe.net http://www.himss.org/IHE http://www.rsna.org/IHE http://www.acc.org/quality/ihe.htm Technical Frameworks Technical Framework Supplements – Trial Implementation Non-Technical Brochures : Calls for Participation IHE Fact Sheet and FAQ IHE Integration Profiles: Guidelines for Buyers IHE Connect-a-thon Results Vendor Products Integration Statements More information…. Questions? IHE Interoperability Workshop