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HL7::CDISC::RIM::CDA:: DMIM:: ODM:: SDS:: The World

HL7::CDISC::RIM::CDA:: DMIM:: ODM:: SDS:: The World. Liora Alschuler CDISC Interchange Bethesda September 30, 2003. Liora Alschuler Current alschuler.spinosa, consultants Co-chair HL7 Structured Documents TC & Marketing Committee Co-editor, Clinical Document Architecture

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HL7::CDISC::RIM::CDA:: DMIM:: ODM:: SDS:: The World

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

  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. The Universal “need a hub”diagram RIM DMIM CDA Protocol SDS aECG ODM Lab model Janus

  4. SGML & the • 5 New Yorker DTDS: • Am. Assoc. of Publishers • Content-specific • For print output • For hypermedia • For database population

  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. Mapping XML • XML is extremely munge-able • We can extract data, transform it, convert it myXML yourXML otherXML someXML newXML oldXML

  7. Use of ODM & CDA in Single-source CDA Complete study-required data entry Complete data entry for patient chart Finalize, sign and archive Initiate document • Why not ODM2CDA? • CDA • Looser • General • Human readable • Comprehensive ODM Clinical document repository (EHR) Clinical trial management SDSinODM/define.XML FDA

  8. Reference Information Model Janus data model ? 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)?

  9. 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

  10. Import CDA directly into Janus and operational dbs? • Requirements: • Re-engineer existing schemas to RIM-derived or • Transform CDA to existing-schema-compatible XML

  11. 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

  12. 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

  13. Reference Information Model Janus data model Refined Model (RMIM)

  14. 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

  15. Disadvantages • Translation required between clinical, operational, submissions XML • Today, these translations, even with standards, must be designed on a case-by-case basis

  16. How to automate translation? e Protocol SubmissionsXML Operations XML HL7XML

  17. eProtocol dictates: Identifiers Vocabulary Extensibility Constraints on source XML Constraints on target XML How to automate translation? e Protocol Operations XML SubmissionsXML HL7XML

  18. The Universal “need a hub”diagram RIM DMIM CDA Protocol SDS aECG ODM Lab model Janus

  19. Clinical documents are the core of healthcare information Diagnostic imaging Pathway, guidelines Public health Shared care Clinical trials Documenting patient care Orders • Relationships: • Equal • Derive • Incorporate • Link • Transform Reimbursement Quality improvement Decision support

  20. Clinical documents are the core of healthcare and clinical trial information Analysis Submissions Operations Documenting patient care Orders Reimbursement Quality improvement But different forms of XML will be required for different applications

  21. 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

  22. 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” Dum, dum, da DMIM? To DMIM or not to DMIM? • 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 • 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+) • 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

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

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