Image Integration and Interoperability Beyond the Enterprise: RSNA's Image Sharing Network Pilot Project

1. Image Integration and Inter- operability BEYOND the Enterprise RSNA’s Image Sharing Network Pilot Project Chris Carr Director of Informatics RSNA

2. Project Overview • In Sept. 2009, RSNA was awarded two-year $4.7 million contract by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) • Funding provided under provisions of ARRA • Designed as pilot project to create “Internet-Based Network for Patient-Controlled Medical Image Sharing” • Network based on IHE XDS-I.b profile for sharing images and reports • Provide for patient control by enabling access via personal health record (PHR) accounts

3. Imaging and Information Sharing • Medical imaging the most commonly ordered diagnostic procedure and fasting growing physician service in US health system • Medicare data show annual utilization increases of about 9%, three times the rate of other physician services • Value of medical imaging in providing accurate, noninvasive diagnosis is unquestioned • Costs of “overutilization” and excessive radiation exposure are growing concerns • Inaccessibility of prior studies is responsible for a significant number of duplicate studies

4. Imaging and Information Sharing Medical images consistently standardized (DICOM) and the part of the health record most frequently provided to patients in digital form Today most often provided on portable media (CD, DVD) Serious limitations to exchange via physical media: inconvenience and failures for producers and consumers of images The growth of advanced imaging techniques (eg, MRI, CT, PET, Nuclear Cardio) has led to an enormous growth in the amount of imaging data acquired—by volume the largest source of electronic health data

5. ARRA - HITECH • Project funded under ARRA to further general goals of HITECH • “Broad use of HIT has the potential to improve health care quality, prevent medical errors, increase the efficiency of care provision and reduce unnecessary health care costs, increase administrative efficiencies, decrease paperwork, expand access to affordable care, and improve population health.” - http://healthit.hhs.gov/portal/server.pt

6. Project Goals Demonstrate a method for sharing images and reports that improves upon portable media Enable patients to create a medical record with access at their control Create standards-based links to personal health record systems to enable sharing of images and reports Establish the practice and expectation of accessibility of health records by participating patients Enroll a growing number of patients throughout course of project—up to 300,000 Provide data on the impact of image sharing on care—surveys and performance metrics Deliver open source reference implementation of systems developed for project

7. Participating Sites • Year 1: Five major medical centers • Mount Sinai, NYC • Mayo Clinic, Rochester, MN • University of California, San Francisco • University of Chicago • University of Maryland Medical Center • Year 2: • Each of the five Year 1 sites recruit three additional “satellite” sites • 7 additional sites begin sharing images for clinical trials

8. Project Team • Steering Committee: PI: David S. Mendelson, MD – Mount Sinai Medical Center Co-PI: Brad Erickson, MD – Mayo Clinic Ron Arenson, MD – University of California, San Francisco David Avrin, MD, PhD – University of California, San Francisco Paul Chang, MD – University of Chicago Eliot Siegel, MD – University of Maryland Medical Center • Technical Committee Micah Adams, MSc – UMMC Steve Langer, PhD – Mayo Steve Moore, MSEE – Mallinckrodt Institute of Radiology, Washington University, St. Louis Femi Oyesanya – University of Chicago Ed Rackus – University of Chicago Ken Shastri, Project Manager Wyatt Tellis, PhD – UCSF Wendy Zhu – University of Chicago

9. Overall Plan • Year 1: • Develop systems needed to enable image sharing through PHRs • Establish sharing of images and reports at five initial sites via PHR • Year 2: • Expand patient information sharing via PHR to satellite sites • Begin sharing images for clinical trials at seven additional research site • Recruit growing number of patients throughout course of trial • Gather information on patient usage and impact on radiology operations at participating sites

10. Systems Design • Based on IHE XDS model • Data to be shared images (CT, MR, X-Ray) and diagnostic reports • All data access will be through PHR accounts • Simplified model for sharing to address policy considerations • Using PHRs to simulate “CD over the Wire”

11. CD Over the Wire • Participating sites currently create (and import) hundreds of imaging CD/DVDs daily • Physical media are time consuming to create • Physical media rely on patient maintenance and delivery to subsequent care providers • In spite of DICOM and IHE, inconsistency in formatting and viewers • Online delivery offers potential to improve incrementally, but significantly upon current state of practice

12. Personal Health Records (PHRs) • “an electronic record of health-related information on an individual that conforms to nationally recognized interoperability standards and that can be drawn from multiple sources while being managed, shared, and controlled by the individual.” National Alliance for Health Information Technology. (2008). Report to the Office of the National Coordinator for Health Information Technology on Defining Key Health Information Technology Terms. http://www.nahit.org/images/pdfs/HITTermsFinalReport_051508.pdf.

13. Steps in Sharing via PHR • Site staff obtain consent and enroll patient • Site staff assemble submission set (images, reports and manifest) and submit to Clearinghouse • Patient is provided two-factor security key (via printout and/or email) for retrieving record through PHR • Site staff provide patient with instructional material on creating and using PHR account • Patient creates account, logs in, uses security key to retrieve record into PHR • Patient provides subsequent care providers with access to records through PHR

14. Network Components • “Edge” Device at each site to bridge local imaging and information systems with image sharing network • Image “Clearinghouse” to temporarily store images and reports • One or more Web-based PHR providers capable of securely retrieving images and reports from clearinghouse into patient account

15. System Architecture

16. Edge Device • Listens to HL7 messages from RIS, captures completed reports • Enables site personnel to create an encounter record by selecting one or more sets of images and reports • Retrieves image studies from PACS • Creates XDS-based payload including images, reports and manifest • Generates security key to identify patient submission set and sends package to Clearinghouse

17. Clearinghouse • Receives, registers and stores submission set (images, reports, manifest) for designated period (eg, 30 days) • Responds to queries from designated PHR systems providing security key and sends requested submission set

18. Personal Health Record (PHR) • Allows creation of secure patient-controlled account • Provides facility for patient to enter security key and retrieves and processes selected encounter record from Clearinghouse • Provides persistent storage for images and reports • Provides Web-based viewer for images and reports • Provides mechanism for secure download of images for viewing in local environment

19. Based on IHE XDS-I Model • Defines transactions (Web services) and encoding of submission set (MTOM/XOP) • Edge Server adds Document Source capability to local RIS-PACS environment • Clearinghouse includes Registry/Repository and PIX Manager (for Patient ID management) • PHR acts as Document Consumer to retrieve submission set

20. IHE XDS-I.b Data Flow

21. IHE XDS Model • Assumes HIE “Affinity Domain”: network of sites with shared security policies and BAAs for information sharing • Access by care providers at sites participating in Health Information Exchange (HIE) is primary use case • Patient demographic information used to link documents acquired at various sites • Longitudinal record exists in HIE registry

22. IHE XDS-I HIE Model Health Information Exchange Network Care Site Care Site Imaging Center Registry ‏ Local Clinic Repository Regional Repository Care Site Repository Care Site Community Health Center Regional Hospital

23. Alterations of IHE Model • Not a Health Information Exchange (HIE) model • No coordination of local patient IDs across sites • No exposed PHI or subject discovery through network • Patient ID Cross-Reference (PIX) Manager functionality greatly simplified • Treats XDS-I payload like XDS.b: no DICOM/WADO retrieve • Initially, information sharing provided only through PHR

24. PHR-based Exchange Multi-site Access via PHR PHR ‏ Care Site Registry ‏ Local Clinic PHR ‏ Care Site Repository Community Health Center Care Site Care Site Imaging Center Regional Hospital

25. Policies Behind Design • Security policy has to satisfy most restrictive policy among participating sites: • No inbound connections to clinical systems • No export of unsecured protected health information (PHI) outside site firewall • No exchange of PHI with other care providers without business associate agreement (BAA) • Patient controls records (like CD model) • PHR is used to create longitudinal records and share information across sites

26. Limitations of Project Model • Not a “universal coverage” model • Depends on active patient to initialize sharing • Does not serve patients debilitated by trauma, age, disease • Initially no aggregation of information for quality, outcomes analysis • Limited by capabilities and policies of PHR providers • Capabilities likely to vary • Business model for PHRs not well established

27. Open Questions • First time medical images are being sent to a device on the Internet. How will CIOs etc. feel about that? • There are still network bandwidth issues at facilities which may create scaling issues • Clearinghouse is based on an “hosted environment model” • PHRs must make modifications to use the RSNA ID and provide viewing functionality

28. Potential Benefits of Project • Establish practice of online information sharing • Encourage patient ownership of electronic health records • Build expectation of patient-control within participating sites • Improve upon portable media for convenience and efficiency of information sharing • Show standards-based mechanism and simple infrastructure for sharing of information through PHRs • Establish functional model that can persist given commensurate business/funding model

29. Summary • Medical images are a high-value use case and a relatively easy win for information sharing • Participants want to promote standards-based approach for implementing information sharing (IHE) • Current business and security policies make it impossible to establish a true HIE model in term of current contract • Information sharing through PHRs is an important incremental step toward greater accessibility of health information for care providers

30. Thanks for joining us! Questions? Find out more at www.ihe.net ccarr@rsna.org