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
Clinical Document Architecture: CDA What is it? How does it allow you to: Do simple things simply Invest in information (doing complex things carefully)
What is CDA? ANSI/HL7 CDA r (Release one) On CD, includes prose spec, RMIM, DTDs December 2004 ballot (Release two) Structured Documents Tech Cmte, zip file on HL7.org – 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,…)
CDA: A Document Exchange Specification This is a CDA and this
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
XML is Extensible Markup Language (www.w3c.org) In XML, structure & format are conveyed by markup which is embedded into the information CDA: XML
CDA = header + body CDA Header 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
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
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
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
CDA Body: Machine Processible Clinical statement Observation Procedure Organizer Supply Encounter Substance Administration Observation Media Region Of Interest Act Optional
Dr. Dolin asserts that Henry Levin manifests hives as a previously-diagnosed allergic reaction to penicillin hives: SNOMED CT CDA Body: Why isnt XML + SNOMED enough?
First: human readable
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
Who is the subject? Target: RIM-defined Id:local Then: supply context
Extl Refs CDA Entries CDA Header CDA Body, Section, and Narrative Block CDA RMIM How are these concepts, relationships defined?
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
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
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
Low End Investment in CDA Many forms of document creation technology Voice (dictation, transcription) eForm EHR (CDA is output as report)
What is the simplest way to create a CDA document? Enter minimal metadata Point to document body See HL7.org NLM Project: freely available application (by 3/1)
What you can do with simple CDA documents: the registry hub what imaging reports are available from the last episode? 1. Create documents2. Register3. Discover 4. Retrieve 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
A tip of the hat to… Aluetietojärjestelmä 40% of Finnish population covered including Helsinki
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
A single data REPRESENTATION standard facilitates multiple document PRESENTATION standards !
Pathologist view: CAP/ACoS standards compliant, template- driven data entry
Repository view: HL7-CDA standard XML with XQuery-ready, context-linked SNOMED encodings
South Hospital Clinician view: Traditional format, print/electronic delivery
One CDA, many applications: pathology Source CDA (pathologist, authors view) Display or print (referring physicians view Archival CDA XML Tumor Board, synopsis, meets CAP reporting guidelines
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
The Challenge: Integrate Patient Care and Clinical Research Data Clinical Research World The Void Electronic Medical Record Patient Care World
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
db lab, ADT, meds, source documents displaymanual entry to CRF re-key CRF lab, ADT, meds, source documents displaydictate chart note LIS HIS Manual creation and re-entry of CRF Redundant creation of chart note CLINICCRO validation Current processes (dual source) CDA in Starbrite Trial
db LIS HIS lab, ADT, meds, source documents displayeCRF dictate chart note Merged workflow: electronic CRF re-used in chart note validation Proposed processes (single source) CLINICARO CDA/ ODM CDA in Starbrite Trial
One CDA, many applications: clinical trials Source CDA (principal investigator, authors view) Clinic note inserted into patient chart Archival CDA XML Case report form submission to research database See demo here, Microsoft pod!
Investing in Information cost benefit 80/20 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
Investing in Information Example of what is hard TermInfo 2004 conference NASA August 1-4, 2004, Houston, TX Notes posted to the summits web page: and New project within HL7 Looked at issues raised by David Markwell (and previously identified by others)
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.
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
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
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) CDA: doing simple things simply, & more complex things slowly