1. What’s New in IHE Integrating the Healthcare Enterprise Kevin O’Donnell Toshiba Medical Systems Rita Noumeir Ph.D. Softmedical

2. IHE Radiology Activities New Supplements in 2005 –Teaching File and Clinical Trial Export (TCE) –Cross-enterprise Document Sharing for Imaging (XDS- I) –Radiology Option for Audit Trail and Node Authentication (ATNA) IHE Radiology Users Handbook PDI Demonstration and Success Stories at RSNA 2005

3. IHE Radiology Integration Profiles Do you we have a new updated radiology profile diagram ??

4. IHE IT Infrastructure Activities Sponsored by HIMSS 9 Profiles deployed including: –ATNA: Audit Trail & Node Authentication –PIX:Patient ID Cross-Referencing –XDS: Cross-Enterprise Document Sharing New Supplements being finalized (Public Comment June 15 - July 15) –Digital Signatures –Cross-Enterprise User Authentication –Patient Management –Notification of Document Availability HIMSS 2005 –Interoperability Showcase –Brailer Press Conference

5. IHE Cardiology Activities Sponsored by ACC, ESC, GMSIH 3 Profiles deployed: –CATH:Cardiac Cath Workflow –ECHO:Echocardiography Workflow –ECG:Retrieve ECG for Display New Supplements being published –Displayable Reports Profile –Cath & Echo Evidence Documents ACC 2005 –First Demo very successful –~1,300 Attendees ASE 2005 –Demo Planned – June 8-15, Boston

6. IHE Lab Activities Sponsored by GMSIH, HPRIM, JAHIS 1 Profile deployed –LWF:Laboratory Scheduled Workflow New Supplements being finalized (Public Comment June 15 – July 15) –Laboratory Point of Care –Laboratory Device Automation –Laboratory Code Set Distribution –Laboratory Information Reconciliation

7. New IHE Domains IHE Radiation Oncology –Sponsored by AAPM / ASTRO –Working on initial profiles IHE Patient Care Coordination –Sponsored by HIMSS –New profile – “Cross Enterprise Document Sharing Content profile : Medical Summary Document” IHE Point of Care Devices –Sponsored by ACCE / HIMSS –Forming committees IHE Eyecare –Sponsored by AAO –Forming domain

8. IHE Regions New national IHE initiatives; governmental interest IHE-North America –U.S., Canada –Demonstrations at RSNA, HIMSS, ACC –Additional Presentations at SCAR, SPIE IHE-Europe –France, Germany, Italy, UK, Norway, Netherlands, Spain & Denmark –Presentations/Demos at ECR, DRK, SIRM, Hopital Expo & UKRC IHE-Asia –Japan, South Korea, Taiwan & China –Demo at JRC

9. IHE Connectathon Massive Cross-vendor Testing –One week; dozens of vendors; thousands of tests –Opportunity to find/resolve issues Participation is Voluntary –Litmus test not a pre-requisite or certification Engineering event –Project Management by Mallinckrodt –Pre-Validation Tools (MESA) –Defined Test Protocols with Verification

10. Annual IHE Connectathons IHE-North America –Connectathon in January 2005 (Chicago, IL) 45 Vendors, 110 Systems, 300 Engineers, 22 Profiles IHE-Europe –Connectathon in April 2005 (Noordwijkerhout, Netherlands) 62 Vendors, 98 Systems, 230 Engineers, 23 Profiles IHE-Asia –Connectathon in Feb 2005 (Yokohama, Japan) 30 Vendors, 70 Systems, 8 Profiles

11. IHE Radiology – Users Handbook SCAR 2005 – Debut of first Edition “Using IHE” for purchasers, system integrators & users Real-world scenarios: acquiring a modality, RIS or PACS Selecting IHE Profiles; Making the Business Case –Based on goals (e.g. reducing errors; increasing throughput) –Identify Profiles that contribute to each goal –Find products that support those Profiles –Specify Profiles in an RFP Installing & Operating IHE Systems –Leverage electronic workflows –Install & Configure the systems –Do Acceptance Testing –Interface with non-IHE systems

12. Teaching File and Clinical Trial Export (TCE)

13. Teaching File and Clinical Trial Export TCE Abstract/Scope DICOM-based mechanism for connecting clinical systems to: –External teaching file systems –External clinical trial systems Meets de-identification requirements for: –Teaching files (HIPAA) –Clinical trials (pseudonymization)

14. Teaching File and Clinical Trial Export Value Proposition for Customers Brings digital imaging to traditionally film-based activities Facilitates clinical research and grant acquisition Standardizes clinical trial data collection Improves the efficiency of teaching file production Supports meeting the Accreditation Council on Graduate Medical Education requirements for teaching files

15. Teaching File and Clinical Trial Export Value Proposition for Companies You can add TF and CT capability to your products just by implementing the TCE profile MIRC is available as a TF and CT Receiver –Teaching File and Clinical Trial system –In use at many universities –Selected by the NCI for clinical trial image transport –Developed, supported and promoted by the RSNA –Free & open source (mirc.rsna.org) –Supported by other CT and TF systems

16. 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 images, 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

17. Teaching File and Clinical Trial Export Example Teaching File Use Case - Part 1: Selection - Radiologist views images for primary diagnosis on Image Display grouped with Export Selector. Export Selector allows images, series and studies to be selected “For Teaching File Export”. Export Selector may also provide a UI allowing the user to enter text notes and select additional items (SR, KIN, GSPS, etc.) for inclusion in exported objects.

18. Teaching File and Clinical Trial Export Example Teaching File Use Case - Part 2: Export - User action triggers Export Selector to send objects and a Key Image Note manifest to Export Manager. –Document Title of the KIN specifies “For Teaching File Export”. –Export Manager de-identifies objects. Export Manager collects objects selected and sends to Receiver. –Receiver may be part of a Teaching File system. TF system receives objects and manifest and stores them for later use by radiologist when authoring the teaching file case. …other use cases are in the Technical Framework

19. Teaching File and Clinical Trial Export Example Clinical Trial Use Case - Part 1: Selection - A clinical trial administrator views images on Image Display grouped with Export Selector. The Export Selector allows images, series and studies to be selected “For Clinical Trial Export”. The administrator identifies the trial. The Export Selector sends images and a KIN manifest to the Export Manager. –The Document Title of the KIN specifies “For Clinical Trial Export”. –Export Manager de-identifies objects.

20. Teaching File and Clinical Trial Export Example Clinical Trial Use Case - Part 2: Export - 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 use cases are in the Technical Framework

21. Teaching File and Clinical Trial Export Export 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” “For Teaching File Export” –Text “disposition” –Information about the requesting user Sent via conventional C-STORE –Not a new SOP Class

22. Teaching File and Clinical Trial Export Export SelectorExport ManagerReceiver Export Instances [Rad 53] Store Export Selection [Rad 51] Store Instances [Rad 50] Store Additional TF Info [Rad 52] Delay for pathology De-identify attributes De-identify pixel data Re-map identifiers

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

24. Cross-enterprise Document Sharing for Imaging (XDS- I)

25. Abstract / Scope Sharing of Imaging Information across health enterprises Imaging Information includes –extensive sets of DICOM instances including images, evidence documents and presentation states –diagnostic reports provided in a "for display" form –selection of diagnostically significant images associated with the report content

26. Sharing Radiology Reports and Images in a Regional Health Information Network Radiology Enterprise A Radiology Enterprise B Physician Office Regional Health Information Network PACS B PACS A Radiology-to-radiology Radiology-to- Physicians

27. Sharing Radiology Reports and Images in a Regional Health Information Network Radiology Enterprise A Radiology Enterprise B Physician Office Regional Health Information Network Cross- Enterprise Registry Patient Id= 3547F45 Report 5/21/1998 : CT Head  B Study 5/21/1998 : CT Head  B Report 2/18/2005 : Chest Xray  A Study 2/18/2005 : Chest Xray  A PACS B PACS A

28. Physicians and Systems within a Regional Health Network - Routine Imaging Referral Radiology Enterprise A Radiology Enterprise B Physician Office Regional Health Information Network Query for Documents Register Imaging Information for sharing Prior imaging Reports & Studies Cross- Enterprise Registry Register Imaging Information for sharing Patient Id= 3547F45 Report 5/21/1998 : CT Head  B Study 5/21/1998 : CT Head  B

29. Physicians and Systems within a Regional Health Network - Routine Imaging Referral Radiology Enterprise A Radiology Enterprise B Physician Office Regional Health Information Network Register Imaging Information for sharing Cross- Enterprise Registry Notification of Doc Availability Register Imaging Information for sharing

30. Physicians and Systems within a Regional Health Network for a Routine Imaging Referral Radiology Enterprise A Radiology Enterprise B Physician Office Prior Imaging Report & Study Regional Health Information Network Query for documents Imaging Report & Study Cross- Enterprise Registry Patient Id= 3547F45 Report 5/21/1998 : CT Head  B Study 5/21/1998 : CT Head  B Report 2/18/2005 : Chest Xray  A Study 2/18/2005 : Chest Xray  A Notification of Doc Availability

31. Value Proposition Imaging component of the Electronic Health Record: Shared imaging Record, in a community, region, etc. Effective means to contribute and access imaging documents across health enterprises. –Without XDS-I, access to the radiology report across health enterprises is difficult Scalable sharing of imaging documents between radiology departments, private physicians, clinics, long term care, acute care with different clinical IT systems. Easy access: Care providers are offered means to query and retrieve imaging documents (images and reports) of interest –with the same mechanisms used to query other documents

32. Value Proposition Distributed: Each Care delivery organization “publishes” imaging information for others. Actual images remain in the source/Image Manager. Cross-Enterprise: A Registry provides an index for published information to authorized care delivery organizations belonging to the same clinical affinity domain. Document Centric: Published clinical data is organized into “clinical documents”. using agreed standard document types (DICOM KOS, PDF and/or text report) Document Content Neutral: Document content is processed only by source and consumer IT systems. Standardized Registry Attributes: Queries based on meaningful attributes ensure deterministic document searches.

33. Document Consumer Retrieve Document Query Documents Patient Identity Source Patient Identity Feed Document Source Document Registry Document Repository Provide & Register Document Set Register Document Set XDS-I Actors and Transactions Image Manager Image Archive Retrieve Images Retrieve Presentation States Retrieve Key Image Note Retrieve Evidence Documents WADO Retrieve

34. Sharing of Extensive DICOM Instance Set

35. Document Registry Document Repository Manifest Reference to image 1 DICOM Manifest Reference to image 2 Reference to image 3 Manifest Clinical Encounter Clinical IT System Query Registry Manifest Retrieve Manifest Reference to image 1 DICOM Manifest Reference to image 2 Reference to image 3 Retrieve ImagesRegister Manifest Manifest

36. Sharing of Imaging Report

37. Radiology system Report Source ….. Findings: Header : Report Type: OB / Gyn BPD... ….. Radiology Report Impressions : Gestational Age... Text Report PDF Report Text +PDF Report

38. Radiology system Report Source Document Registry Document Repository Report Clinical Encounter Clinical IT System Query Registry Retrieve ReportRegister Report Report ….. Findings: Header : Report Type: OB / Gyn BPD... ….. Radiology Report Impressions : Gestational Age...

39. Linking Report to Selected Images Radiology system Report Source ….. Findings: Header : Report Type: OB / Gyn BPD... ….. Radiology Report Relevant Image Gestational Age... WADO URI Link to image

40. Radiology Option for Audit Trail and Node Authentication (ATNA)

41. Audit Trail and Node Authentication (ATNA) + Radiology Option Abstract / Scope Defines basic security features for an individual system for use as part of the security and privacy environment for a healthcare enterprise. –Provides host level authentication, which is used in conjunction with the user authentication from EUA and XUA. –Provides audit trail mechanism for monitoring activities related to security and patient privacy

42. Audit Trail and Node Authentication (ATNA) + Radiology Option Compatibility with Basic Security “But, what if I already have systems that support Basic Security?” –ATNA + Radiology Option is backward compatible with Basic Security –Integration Statements should change support claim from “Basic Security” to “Radiology Option for ATNA”

43. ATNA Value Proposition Protect Patient Privacy and System Security: –Meet ethical and regulatory requirements Enterprise Administrative Convenience: –Unified and uniform auditing system –Common approach from multiple vendors simplifies definition of enterprise policies and protocols. –Common approach simplifies administration Development and support cost reduction through Code Re-use: –Allows vendors to leverage single development effort to support multiple actors –Allows a single development effort to support the needs of different security policies and regulatory environments.

44. ATNA vs Basic Security Value Proposition Why Change? Use an Audit Repository that supports more than just imaging domains like Radiology. Use a reliable, error correcting, secure transport for audit messages

45. ATNA Security Measures Authentication: Authentication: Establish the user and/or system identity, answers question: “Who are you?” ATNA defines: How to authenticate network connections. ATNA Supports: Authentication mechanisms, e.g. Enterprise User Authentication (EUA) or Cross Enterprise User Authentication (XUA).. Authorization and Access control: Authorization and Access control: Establish user’s ability to perform an action, e.g. access to data, answers question: “Now that I know who you are, what can you do?” ATNA defines: How to authorize network connections. ATNA requires: System internal mechanisms for both local and network access.

46. ATNA Security Measures Accountability and Audit trail: Accountability and Audit trail: Establish historical record of user’s or system actions over period of time, answers question: “What have you done?” ATNA Defines: Audit message format and transport protocol

47. ATNA Node Authentication X.509 certificates for node identity and keys TCP/IP Transport Layer Security Protocol (TLS) for node authentication, and optional encryption Secure handshake protocol of both parties during Association establishment: –Identify encryption protocol –Exchange session keys Actor must be able to configure certificate list of authorized nodes. ATNA presently specifies mechanisms for HTTP, DICOM, and HL7

48. Why node authentication? Many systems are shared access, e.g. CT systems, where the machine identity is more important than the operator’s identity for security purposes. A CT operator is only permitted to update CT records from a CT system. Some systems operate autonomously, e.g. PACS archive. Knowing identity of the PACS administrator on duty is not useful when monitoring PACS activity. There might be nobody logged in. Machine access is usually controlled by the site administration. Even authorized users are not permitted to use personal machines.

49. ATNA Auditing System Designed for surveillance rather than forensic use. Two audit message formats –IHE Radiology interim format, for backward compatibility with radiology –IETF/DICOM/HL7/ASTM format, for future growth DICOM Supplement 95 IETF Draft for Common Audit Message ASTM E.214 HL7 Audit Informative documents Both formats are XML encoded messages, permitting extensions using XML standard extension mechanisms.

50. ATNA Auditable Events Actor-start-stop The starting or stopping of any application or actor. Audit-log-used Reading or modification of any stored audit log Begin-storing- instances The storage of any persistent object, e.g. DICOM instances, is begun Health-service-event Other health service related auditable event. Images-availability- query The query for instances of persistent objects. Instances-deleted The deletion of persistent objects. Instances-stored The storage of persistent objects is completed.

51. ATNA Auditable Events Medication Medication is prescribed, delivered, etc. Mobile-machine-event Mobile equipment is relocated, leaves the network, rejoins the network Node-authentication- failure An unauthorized or improperly authenticated node attempts communication Order-record-event An order is created, modified, completed. Patient-care- assignment Patient care assignments are created, modified, deleted. Patient-care-episode Auditable patient care episode event that is not specified elsewhere. Patient-record-event Patient care records are created, modified, deleted.

52. ATNA Auditable Events PHI-export Patient information is exported outside the enterprise, either on media or electronically PHI-import Patient information is imported into the enterprise, either on media or electronically Procedure-record- event The patient record is created, modified, or deleted. Query-information Any auditable query not otherwise specified. Security-administration Security alerts, configuration changes, etc. Study-object-event A study is created, modified, or deleted. Study-used A study is viewed, read, or similarly used.

53. UPDATE Where Is More Information Available? www.ihe.net –IHE Radiology Technical Framework V5.5 –IHE IT Technical Framework V1.1 –IHE Lab Technical Framework V1.1 –IHE Cardiology Technical Framework V1.0 –IHENews Mailing List –IHE Primer and IHE FAQ –IHE Integration Profiles: Guidelines for Buyers –IHE Presentations –IHE Connectathon Results –IHE Integration Statement Links

54. Ask your vendors: Which IHE Profiles do they support on which systems?