alschuler.spinosa copyright 2003, liora alschuler hl7::cdisc::rim::cda:: dmim:: odm:: sds:: the...
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HL7::CDISC::RIM::CDA:: DMIM:: ODM:: SDS::
The World
HL7::CDISC::RIM::CDA:: DMIM:: ODM:: SDS::
The World
Liora AlschulerCDISC Interchange
BethesdaSeptember 30, 2003
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• Liora Alschuler• Current
– alschuler.spinosa, consultants– Co-chair HL7 Structured Documents TC & Marketing
Committee– Co-editor, Clinical Document Architecture– [email protected]
• Background– Helped bring XML to HL7 in 1997– Wrote “ABCD… SGML: A Manager’s Guide to Structured
Information” in 1995– Electronic text: 1986 -- 1998
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The Universal “need a hub”diagram
Protocol
SDS
CDA
aECG
Lab modelODM
RIM DMIM
Janus
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SGML & the5 New Yorker DTDS:
1. Am. Assoc. of Publishers
2. Content-specific
3. For print output
4. For hypermedia
5. For database population
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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.”
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Mapping XML
• XML is extremely munge-able• We can extract data, transform it,
convert it
someXML
otherXML
newXMLoldXML
yourXML
myXML
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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 management
Clinical document repository (EHR)
CDA
• Why not ODM2CDA?– CDA
• Looser• General• Human
readable• Compreh
ensive
FDA
SDSinODM/define.XML
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lerAre 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)?
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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
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Import CDA directly into Janus and
operational dbs?
•Requirements:
•Re-engineer existing schemas to RIM-derived or
•Transform CDA to existing-schema-compatible XML
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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
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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
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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
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Disadvantages
• Translation required between clinical, operational, submissions XML
• Today, these translations, even with standards, must be designed on a case-by-case basis
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How to automate translation?
HL7XMLSubmissionsXML
Operations XML
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How to automate translation?
HL7XMLOperations XML
SubmissionsXML
• eProtocol dictates:– Identifiers– Vocabulary– Extensibility– Constraints on
source XML– Constraints on
target XML
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The Universal “need a hub”diagram
Protocol
SDS
CDA
aECG
Lab modelODM
RIM DMIM
Janus
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Clinical documents are the core of healthcare information
Documenting patient care
Shared care
Clinical trials
Public health
Orders
Quality improvement
Reimbursement
Diagnostic imaging
Pathway, guidelines
Decision support
Relationships:
• Equal
• Derive
• Incorporate
• Link
• Transform
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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
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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
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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+)
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Thank you
Liora [email protected]/785-2623East Thetford, VT
HL7.org, Structured Documents TCHL7IHEjointdemo.org, HIMSS demo