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HL7’s Clinical Document Architecture

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Presentation on theme: "HL7’s Clinical Document Architecture"— Presentation transcript:

1 HL7’s Clinical Document Architecture
Liora Alschuler HIMSS Dallas, Texas February, 2005

2 About me Liora Alschuler alschuler.spinosa, consultants
Co-chair HL7 Structured Documents TC Co-editor, CDA Member, 2005, HL7 Board of Directors Project manager for Operation Jumpstart, (initial design of CDA) past Chair, XML SIG Also contributing: Bob Dolin, MD, Kaiser-Permanente; John Madden, MD, Duke University Medical Center

3 Clinical Document Architecture: CDA
What is it? How does it allow you to: Do simple things simply Invest in information (doing complex things carefully)

4 What is CDA? ANSI/HL7 CDA r1-2000 (Release one)
On CD, includes prose spec, RMIM, DTDs December 2004 ballot (Release two) Structured Documents Tech Cmte, zip file on – PASSED, will be published shortly A specification for document exchange using XML, the HL7 Reference Information Model (RIM) Version 3 methodology and vocabulary (SNOMED, ICD, local,…)

5 CDA: A Document Exchange Specification
This is a CDA and this

6 CDA: A Document Exchange Specification
A CDA can be a Discharge Summary Referral (CCR is one such) Progress Note H&P Public health report … any content that carries a signature

7 CDA: XML XML is Extensible Markup Language (
In XML, structure & format are conveyed by markup which is embedded into the information

8 Sample CDA

9 CDA = header + body CDA Header CDA Body
Metadata required for document discovery, management, retrieval CDA Body Clinical report Discharge Summary Referral Progress Note H&P Public health report … any content that carries a signature

10 CDA Header The header describes:
The document itself (unique ID, document type classification, version) Participants (providers, authors, patients…) Document relationships (to orders, other documents…) Metadata sufficient for document management

11 CDA Body: two types of markup
Human-readable “narrative block”, all that is required to reproduce the legal, clinical content Optional machine-readable CDA Entries, which drive automated processes

12 CDA Body: Human-readable
paragraph list table caption link content revise (delete/insert) subscript/superscript special characters (e.g., symbols, Greek letters) in Unicode emphasis line break renderMultiMedia (non-XML graphics, video…) required

13 CDA Body: Machine Processible
Clinical statement Observation Procedure Organizer Supply Encounter Substance Administration Observation Media Region Of Interest Act Optional

14 ? = = CDA Body: Why isn’t XML + SNOMED enough?
“hives”: SNOMED CT = “Dr. Dolin asserts that Henry Levin manifests hives as a previously-diagnosed allergic reaction to penicillin” =

15 First: human readable

16 Next: series of related statements
Allergy to penicillin Observation: RIM-defined Prior dx: SNOMED Allergy to penicillin: SNOMED Hives Prior dx: SNOMED Hives: SNOMED Hives is a manifestation of a reaction to penicillin Relationship: RIM-defined Next: series of related statements

17 Then: supply context Who is the subject? Target: RIM-defined Id: local

18 CDA RMIM How are these concepts, relationships defined? CDA Header
CDA Body, Section, and Narrative Block CDA Entries Extl Refs

19 Investing in Information
CDA XML can be simple CDA XML can be complex Simple encoding relatively inexpensive Complex encoding costs more You get what you pay for: like charging a battery, the more detailed the encoding the greater the potential for reuse

20 CDA: Return on Investment
Low end: Access to documents “please send referral letter to…” “please get me the discharge summary…” “what imaging reports are available from the last episode?” High end: Reuse Send synopsis to tumor board Attach to claim for automated adjudication of payment Extract data for clinical research

21 Low End Applications for CDA
Persistant, accessible, human-readable documents Document requirements: CDA header Release One or Two body Narrative block Non-semantic markup (HTML-like) Document options: More complex markup can be inserted, to be used or ignored

22 Low End Investment in CDA
Many forms of document creation technology Voice (dictation, transcription) eForm EHR (CDA is output as “report”)

23 What is the simplest way to create a CDA document?
Enter minimal metadata Point to document body See NLM Project: freely available application (by 3/1)

24 What you can do with simple CDA documents: the registry hub
4. Retrieve “what imaging reports are available from the last episode?” 1. Create documents 2. Register 3. Discover Ubiquitous access to distributed information By class of document, patient, provider, encounter (CDA header metadata) Documents remain under local control Document creation technology evolves under local control Registry (hub) for access control, identifier xRef

25 A tip of the hat to… Aluetietojärjestelmä
40% of Finnish population covered including Helsinki

26 Investing in Information
Simple documents retrieval, display metadata registry Two examples of higher-level investment: HIMSS 2004, Dr. John Madden, Duke University Medical Center, created a CDA pathology note that doubles as a tumor board report Also at Duke, the Starbrite “Single Source” Proof of Concept for clinical trials

27 A single data REPRESENTATION standard
facilitates multiple document PRESENTATION standards !

28 CAP/ACoS standards compliant, template-driven data entry
Pathologist view: CAP/ACoS standards compliant, template-driven data entry

29 Repository view: HL7-CDA standard XML with XQuery-ready, context-linked SNOMED encodings

30 Traditional format, print/electronic delivery
South Hospital Clinician view: Traditional format, print/electronic delivery

31 Irrelevant items filtered, stage computed automatically
South Hospital Tumor registrar view: Irrelevant items filtered, stage computed automatically

32 One CDA, many applications: pathology
Display or print (referring physician’s view Source CDA (pathologist, author’s view) Archival CDA XML Tumor Board, synopsis, meets CAP reporting guidelines

33 Investing in Information
“Single Source” Create once Use many Reuse clinical data in clinical trials Duke Clinical Research Institute Proof of Concept Principals: Landen Bain, Rebecca Kush, Liora Alschuler Microsoft, primary technology partner

34 The Challenge: Integrate Patient Care and Clinical Research Data
Patient Care World Clinical Research World Electronic Medical Record The Void

35 Single Source vs Previous Solutions
eSource & electronic data capture redundant with creation of clinic note require information reside in EMR/EHR proprietary data formats CDA & CDISC in “single-source” capture trial data, merge it into clinic note (re-use) work with current technology, workflow open, non-proprietary data formats

36   CDA in Starbrite Trial   Current processes (dual source)
Manual creation and re-entry of CRF HIS validation lab, ADT, meds, source documents db LIS display manual entry to CRF re-key CRF CLINIC CRO Current processes (dual source) HIS lab, ADT, meds, source documents LIS display dictate chart note Redundant creation of chart note

37  CDA in Starbrite Trial  Proposed processes (single source)
Merged workflow: electronic CRF re-used in chart note HIS validation lab, ADT, meds, source documents CDA/ ODM LIS db display eCRF Proposed processes (single source) dictate chart note CLINIC ARO

38 One CDA, many applications: clinical trials
Clinic note inserted into patient chart See demo here, Microsoft pod! Source CDA (principal investigator, author’s view) Archival CDA XML Case report form submission to research database

39 Investing in Information
Disecting the curve What is easy: Header Human-readable body Low degree of coding What is hard: Concensus on semantic content requirements Model/vocabulary interface cost x 80/20 benefit

40 Investing in Information
Example of what is hard TermInfo 2004 conference NASA August 1-4, 2004, Houston, TX Notes posted to the summit’s web page: and New project within HL7 Looked at issues raised by David Markwell (and previously identified by others)

41 Investing in information: what is hard?
Issue 1: Code/value dichotomy abdominal tenderness is observed examination (code) / abdomen tender (value); abdominal examination / abdomen tender; abdominal palpitation / abdomen tender; abdominal tenderness / present, etc.

42 Investing in information: what is hard?
Strong collaborative effort established to address issues Most syntatic issues addressed, full concentration on semantic interoperability Issues will be resolved, but will take time and experience

43 Investing in Information: phased approach
Lay groundwork CDA header metadata XML R1 or R2 CDA body Build Concensus on requirements Understanding of modeling process Vocabulary glossary Understand Relationship of vocabulary to model Introduce interoperable semantic content as requirements and business drivers dictate

44 CDA: doing simple things simply, & more complex things slowly
What can be done now Basic (Level One) CDA (R1 or R2) can be created with any degree of technical sophistication Document scanner+web form Transcription Electronic health record What can be done later Increase coding sophistication as business requirements dictate (return on investment and regulation)


46 Thank you! Questions?

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