1. Integrating the Healthcare Enterprise RSNA/NIBIB Image Sharing: An IHE profile tailored to Consumer Control David S. Mendelson, M.D. Chief of Clinical Informatics The Mount Sinai Medical Center Co-chair IHE Board

2. Meaningful Use Objectives Improving Quality, Safety, Efficiency & Reducing Health Disparities Engage Patients and Families in Their Care Improve Care Coordination Ensure Adequate Privacy and Security Protections for Personal Health Information 2

3. IHE XDS profile was built around the concept of an affinity domain Legal relationships at the enterprise level How can the consumer fit into this model  Use the same actors and transactions 3

4. Image sharing- Why? Benefit of historical exam during interpretation Rapidly growing cost of healthcare especially growing utilization of imaging Overutilization Prevent duplicate exam because a recent exam is inaccessible Radiation exposure Quality Expedites clinical care through easy availability of imaging examination

5. Issues that govern sharing Imaging Exams What is our product? Who are our customers? What are the mechanisms of sharing? What are the impediments? Technology Policy

6. Issues that govern sharing Imaging Exams What is our product? Who are our customers? What are the mechanisms of sharing? What are the impediments? Technology Policy

7. Our Product – Information! Imaging Exam Order Direct patient history Prior exams Report Demographics Referring Clinician Reporting Team Indication Narrative Procedure Impression Structured report

8. Issues that govern sharing Imaging Exams What is our product? Who are our customers? What are the mechanisms of sharing? What are the impediments? Technology Policy

9. Patient Radiology Physician 2 nd Radiology Consulting Physician Clinical Trial Patient

10. Who? Primary Clinician Often has existing access Not always Consulting Physician Ambulatory Imaging Center – Hospital Either direction Second Hospital or enterprise Patient or relative Research De-identified

11. Issues that govern sharing Imaging Exams What is our product? Who are our customers? What are the mechanisms of sharing? What are the impediments? Technology Policy

12. Film Are you old enough to remember film? Still exists Clinical offices

14. Film Today – generally regarded as the least desirable media Expensive Medium Limited latitude Expensive to handle Sharing Copying expensive, time consuming, bulky Accessibility Import - scanning

15. The “CD”- “better than sliced bread” or “be careful what you ask for – you may get it” Portable Compact Can hold thousands of images Inexpensive ($0.50 or less) What’s wrong here?

17. CDs- Problems Different data formats Non-Dicom Different viewers End-user confusion Defective Discs Disc must be in your possession Patient Identity Wrong Patient on Disc Time consuming Clinician’s are confused They share their confusion with their Radiologist

18. Difficult Discs-Wrong Patient/Information Mayo Clinic Unreadable Disc – 0.6% Wrong- 0.2% Mount Sinai- estimates 5% cannot be imported Rare wrong patient

19. Patient Identity Patient has a MRN at importing institution Patient does not have a MRN at importing institution MRN is in the DICOM header

20. Help!

21. Importing an Exam- the process Identify the patient locally Confirm the images belong to the patient Determine the name the imported exam Convert into DICOM format Scan film Read disc ? Dicom Read from buffer Import and perform reconciliation Into PACS? Into RIS? Into a parallel system? EMR Is it for interpretation? Is it to be billed?

22. Importing an Exam – a variant Establish a standard viewing environment for clinicians for outside exams. Allow them to designate exams for import from this environment Import into local PACS

23. Issues for exam import Accuracy of the foreign information Compatibility Legal? Responsibility ??? Changes to the exam or report after import How does one become aware?

24. CD- Opportunities to improve Importing a disc provides the opportunity to correct Robust import solutions -commercial Standard import interface Reconciliation process Trained personnel Standards DICOM PDI extensions (IHE- Portable Documents for Imaging) BIR- (IHE- Basic Image Review) Minimum requirement for review

25. Mechanisms of Sharing- Reports Mail RIS FAX E-Mail PACS VPN Internet EMR-Patient Portal PHR

26. When to release a Report vs. Image? o The patient is entitled Legal Practical Is the patient prepared for the information in the report? o Immediate use to clinician o May be meaningless to most patients other than a curiosity

27. Network/Internet base sharing Replace the CD (SneakerNet) with the Internet Convenience vs. Security New opportunities Shared Image processing Efficiencies

28. Network/Internet base sharing Proprietary applications Usually used within an enterprise or a limited domain with legal agreements Health Information Exchange (HIE) Multiple enterprises with a set of legal agreements Often have selected their own standards- not truly open standards based Sustainability

29. Network/Internet Security/Privacy-Confidentiality HIPAA Security/ Privacy-Confidentiality HIPAA This is the networked version of the CD More convenient Same issues need to be addressed

30. Network/Internet VPN/Enterprise Portal Clinical Staff Patient Temporary credentials Enterprise- multi-sites; proprietary solution Multiple PACS and RIS feed one central archive All credentialed can view that archive Point to Point networks HIE Standards based or proprietary sharing network IHE model Patient Centric model / PHR

31. Challenges to exchange Who pays for an exchange infrastructure What is the persistence of the information in the exchange Are images different from other forms of healthcare data Easy secure access is good for the patient Does it endanger the provider?- is this an impediment? Economic adjustments and evolution are likely to occur Balance of cost control vs. Quality Reduction in Radiation exposure Not all patients agree

32. Methods Point to Point E-mail Cloud Computing HIE (Health Information Exchange) These are not mutually exclusive- there is overlap

33. Point to Point A limited number of entities establish direct connections Usually requires a direct formal relationship (legal) Can be successful to address very specific interoperability problems Doesn’t scale

34. HIE Requires legal relationships between participants Requires patient identity management Enables a greater number of entities to participate May be scalable HIE to HIE Consent issues Commonly all or nothing rather than episode or event based Patients may wish to only expose limited pieces of data

35. Sharing Healthcare Information in the Cloud Hospital Imaging Center Primary Doctor Specialist Hospital Patient Patient Surrogate

36. Cloud Computing o WHO o Enterprise o HIE o Consumer o WHAT o Services o Transactions o Archive

37. IHE-XDS (Cross-Enterprise Document Sharing) XDS.a XDS- I.a XDS.b ?? XDS-I.b a vs. b Related to web standards and transactions

38. XDS

39. XDS-I

40. Canada Health Infoway

41. NIBIB/RSNA Image Sharing Project A Standards Based Solution

44. Goals of Contract NIBIB contract Bootstrap an IHE based network Primary emphasis is Consumer Control through PHRs Can be extended to other forms of sharing HIE Security and Confidentiality are drivers Replacement / Alternative to CD

46. NIBIB contract summary o Consumer Control o Employ IHE solutions whenever possible IHE generally has not focused on consumer driven solutions but rather on institutional and enterprise workflow o 5 Academic Institutions Mayo Clinic Mount Sinai Medical Center University of California San Francisco University of Chicago University of Maryland o Establish a clearinghouse o Engage PHRs o 300,000 patients over 2 years

47. Image Sharing/Elements of Solution Edge Server Register a patient Listens to a Radiology Information System (RIS)- looking for a complete exam Retrieves Image set from PACS and Report from RIS Send both to clearinghouse PHI hidden; an RSNA ID and 2 nd factor security token are used to identify the patient Clearinghouse (XDS-I) – functions as a secure router Transiently hold encrypted patient data PHR Consumer controls upload and future access Must have RSNA ID available and know answer to 2 nd factor question Develop web based viewers Download full DICOM data set Misc Consumers

48. Software architecture Prepare contentPoll database, get report, get exam,prepare big fat file Background java srvlet25 days Transfer contentPoll database for transfer out, package content into xds.b Background java srvlet35 days HL7 receiverReceive HL7 A04 messages, extract reports and store them in database Mirth HL7 Channel. Let Mirth create its default database, all script work-but may have to customize per site 65 days for 5 sites Token AppCreate new tokens based on two parts, associate token with accession numbers, update database, user interface with login, get patient info,create job Ajax based web front-end,JavaServlet for CFIND using dcm4che, creating job in the RSNA database, creating tokens using kerberos – tokens generated locally 30 days DatabaseStore reports, logs, audit trails, user accounts, etc. Mirth instance for HL7 & DICOM, RSNA instance for everything else 50 days – 2 databases Management AppCreate users, monitor logs, check health Ajax gui front end, backend servlet, dicom targets etc. 45 days

50. Project design assumptions Security is paramount Restrictive policy PHI is never unsecured Consumer controls the flow of information by placing it in the PHR Diminishes the need for BAAs between enterprises Imaging Site to Clearinghouse Clearinghouse to PHR

51. Advantages of Approach Push model No Query of PACS from outside the firewall Full DICOM data set is available Web viewers Download and Import to PACS Report is available Historical exams can be sent simultaneously Consumer controls flow of information Affords the patient the ability to select what information to share Is this good?

52. Future Directions Refine Workflow Initial workflow is to replace a CD Exam updates Download DICOM data and archive in a local PACS Edge server as a platform Radiation Monitoring Peer Review Quality Metrics

53. Research CTP- The RSNA Clinical Trial Processor CTP is a stand-alone program that provides all the processing features of a MIRC site for clinical trials in a highly configurable and extensible application. It connects to FieldCenter applications and can also connect to MIRC sites when necessary. CTP has the following key features: Single-click installation. Support for multiple pipelines. Processing pipelines supporting multiple configurable stages. Support for multiple quarantines for data objects which are rejected during processing. Pre-defined implementations for key components: HTTP Import DICOM Import DICOM Anonymizer XML Anonymizer File Storage Database Export HTTP Export DICOM Export FTP Export Web-based monitoring of the application's status, including: configuration logs quarantines status

54. Issues that govern sharing Imaging Exams What is our product? Who are our customers? What are the mechanisms of sharing? What are the impediments? Technology Policy

55. Conclusions We live in a heterogeneous world needing multiple solutions CDs and portable media have both advantages and drawbacks Compliance with standards helps We are transitioning to network/internet solutions Security and confidentiality are even more difficult ONC and State policies will foster these solutions Solutions are evolving Proprietary solutions are often easier to implement Solutions based on open standards will provide the patient with greater flexibility Interoperability will require an adjustment to the way we all think of healthcare data

56. Future Directions Refine Workflow Initial workflow is to replace a CD Exam updates Download DICOM data and archive in a local PACS Edge server as a platform Radiation Monitoring Peer Review Quality Metrics

57. Radiation Exposure Monitoring Profile - REM Supplement to Technical Framework for Trail Implementation Acquisition modalities inlcudes information regarding dose exposure Estimates Permits communication of that information to other systems Useful for Individual lifetime estimates as well as Population analysis 57

58. Radiation Exposure Monitoring (REM) Includes CT Plain X-Ray Mammography Current Exclusions Nuclear Medicine RT Brachytherapy 58

59. DICOM Dose SR objects DICOM 2008 PS 3.3: A.35.8 X-Ray Radiation Dose SR IOD