Integrating the Healthcare Enterprise

1. Integrating the Healthcare Enterprise What’s New in IHE 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 ExportTCE 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 ExportValue 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 ExportValue 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 ExportExample 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 ExportExample 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 ExportExample 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 ExportExample 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 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” • “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 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]

23. 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

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 Imagesin a Regional Health Information Network Regional Health Information Network Radiology Enterprise B PACS B Radiology-to-radiology Radiology-to-Physicians PACS A Physician Office Radiology Enterprise A

27. Sharing Radiology Reports and Imagesin a Regional Health Information Network Regional Health Information Network Radiology Enterprise B PACS B • 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 Cross-Enterprise Registry PACS A Physician Office Radiology Enterprise A

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

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

30. Prior Imaging Report & Study Query for documents Notification of Doc Availability Imaging Report & Study Physicians and Systems within a Regional Health Network for a Routine Imaging Referral Regional Health Information Network Radiology Enterprise B • 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 Cross-Enterprise Registry Physician Office Radiology Enterprise A

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

34. Sharing of Extensive DICOM Instance Set

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

36. Sharing of Imaging Report

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

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

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

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

41. Audit Trail and Node Authentication (ATNA) + Radiology OptionAbstract / 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 OptionCompatibility 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. ATNAValue 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 SecurityValue 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. ATNASecurity Measures • 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: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. ATNASecurity Measures • 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. ATNANode 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. ATNAAuditing 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.

49. 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

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