1. alschuler.spinosa copyright 2003, Liora Alschuler HL7::CDISC::RIM::CDA:: DMIM:: ODM:: SDS:: The World Liora Alschuler CDISC Interchange Bethesda September 30, 2003

2. alschuler.spinosa copyright 2003, Liora Alschuler 2 Liora Alschuler Current –alschuler.spinosa, consultants –Co-chair HL7 Structured Documents TC & Marketing Committee –Co-editor, Clinical Document Architecture –liora@the-word-electric.com Background –Helped bring XML to HL7 in 1997 –Wrote “ABCD… SGML: A Manager’s Guide to Structured Information” in 1995 –Electronic text: 1986 -- 1998

3. alschuler.spinosa copyright 2003, Liora Alschuler 3 The Universal “need a hub”diagram Protocol SDS CDA aECG Lab model ODM RIMDMIM Janus

4. alschuler.spinosa copyright 2003, Liora Alschuler 4 SGML & the 5 New Yorker DTDS: 1.Am. Assoc. of Publishers 2.Content-specific 3.For print output 4.For hypermedia 5.For database population

5. alschuler.spinosa copyright 2003, Liora Alschuler 5 SGML & Conclusions: “This session of the conference helped attendees to see the relationship between the design of an SGML document structure and the use or uses projected for the information.” Example: Db: content-specific naming Hypermedia: short, generic names “…when an organization is designing an SGML information database it must relate its goals for the use and reuse of its information to the new and old product applications it plans.”

6. alschuler.spinosa copyright 2003, Liora Alschuler 6 Mapping XML XML is extremely munge-able We can extract data, transform it, convert it someXML otherXML newXML oldXML yourXML myXML

7. alschuler.spinosa copyright 2003, Liora Alschuler 7

8. alschuler.spinosa copyright 2003, Liora Alschuler 8 Use of ODM & CDA in Single- source ODM Initiate document Complete study- required data entry Complete data entry for patient chart Finalize, sign and archive Clinical trial manage ment Clinical document repository (EHR) CDA Why not ODM2CDA? –CDA Looser General Human readable Comprehen sive FDA SDSinODM/de fine.XML

9. alschuler.spinosa copyright 2003, Liora Alschuler 9 Are transforms hand-crafted, or can they be automated? Does it scale? How do you scope a standard? How many transforms are too many? And, ultimately, what does that tell us about “semantic interoperability” (eg, doing useful work)?

10. alschuler.spinosa copyright 2003, Liora Alschuler 10 Make the ODM into a RIM- derived schema? Requirements: RMIM, HD, ITS, datatypes, vocab, tweak, iterate Won’t look like ODM Won’t look like CDA

11. alschuler.spinosa copyright 2003, Liora Alschuler 11 Import CDA directly into Janus and operational dbs? Requirements: Re-engineer existing schemas to RIM- derived or Transform CDA to existing-schema- compatible XML

12. alschuler.spinosa copyright 2003, Liora Alschuler 12 Sanity check Re-engineer existing databases? not Optimize XML for particular task? yup Translate and extract data as required at the instance level, XML2XML Ensure that cross-walk between schemas feasible Ensure that essential information captured in all models such that transformation is possible

13. alschuler.spinosa copyright 2003, Liora Alschuler 13 Recommendation View HL7 RIM-defined data as canonical source, as captured at source Design CDISC exchange schemas for business requirements (operations, reporting, analysis, validation, …), just as CDISC has already done/is doing Extract or transform –from HL7 RIM-derived XML-encoded source (CDA, lab, aECG…) –to CRO/CDISC/FDA-encoded target XML for insertion into appropriate schema

14. alschuler.spinosa copyright 2003, Liora Alschuler 14

15. alschuler.spinosa copyright 2003, Liora Alschuler 15 Advantages Current db designs retain value Source data available in richly encoded, complete, canonical form Exchange schemas standardized for interoperability Submission and operational schemas optimized for dataprocessing, analysis Maintain link back to comprehensive original documentation: original will always be more comprehensive than research schema

16. alschuler.spinosa copyright 2003, Liora Alschuler 16 Disadvantages Translation required between clinical, operational, submissions XML Today, these translations, even with standards, must be designed on a case-by-case basis

17. alschuler.spinosa copyright 2003, Liora Alschuler 17 How to automate translation? HL7XML Submissions XML Operations XML

18. alschuler.spinosa copyright 2003, Liora Alschuler 18 How to automate translation? HL7XML Operations XML Submissions XML eProtocol dictates: –Identifiers –Vocabulary –Extensibility –Constraints on source XML –Constraints on target XML

19. alschuler.spinosa copyright 2003, Liora Alschuler 19 The Universal “need a hub”diagram Protocol SDS CDA aECG Lab model ODM RIMDMIM Janus

20. alschuler.spinosa copyright 2003, Liora Alschuler 20 Clinical documents are the core of healthcare information Documenting patient care Shared care Clinical trials Public health Orders Quality improvement Reimbursement Diagnostic imagingPathway, guidelines Decision support Relationships: Equal Derive Incorporate Link Transform

21. alschuler.spinosa copyright 2003, Liora Alschuler 21 Clinical documents are the core of healthcare and clinical trial information Documenting patient care Operations Submissions Orders Quality improvement Reimbursement Analysis But different forms of XML will be required for different applications

22. alschuler.spinosa copyright 2003, Liora Alschuler 22 Conclusions If every data schema were modeled on the RIM, all the data could be HL7 derived (lab, CDA, aECG…) All schemas are not modeled on the RIM Therefore, –Render unto the HL7 RIM that which originates in the clinical environment –Render unto CDISC-optimized XML that which needs to travel to operational and submissions databases in the clinical research environment –Keep the link between the two –Automate transformation through standard protocol, reconciled with the RIM

23. alschuler.spinosa copyright 2003, Liora Alschuler 23 Dum, dum, da DMIM?To DMIM or not to DMIM? From RIM to XML: –RMIM –Hierarchical descriptor –XML Design of XML ITS Tooling output Tweak Bulk of CDA XML hand-crafted datatypes and “narrative block” Development of RMIM –First balloted in 2000 (3-4 cycles) –Reconciliation –Three years of implementation (~12 countries, 20+ sites) –Incremented through user requirements –Second ballot 2003-4 Struc doc DMIM? –Requires reconciliation w/ HL7 TCs –Requires reconciliation with “CMETs” –Requires refinement of full RIM –Requires encyclopedic understanding of expression of clinical information –Still in our future CDA Implementations –EU framework (12+ countries) “PICNIC” –NHII: Belgium, Greece, Ireland, Denmark, Finland, Germany –National claims processing: Canada, US (prop) –Referrals: US, Japan, New Zealand, Australia, Germany –Research: Germany, Canada, US (VA, KP+)

24. alschuler.spinosa copyright 2003, Liora Alschuler 24 Thank you Liora Alschuler liora@the-word-electric.com 802/785-2623 East Thetford, VT HL7.org, Structured Documents TC HL7IHEjointdemo.org, HIMSS demo