Clinical Document Architecture: Care Record Summaries Liora Alschuler alschuler.spinosa Co-chair, Structured Documents TC Co-editor, CDA HL7 Board of Directors Liora Alschuler liora@the-word-electric.com

Health Level Seven (HL7.org) Standards Development Organization Developing standards for interoperability Patient care Public health Clinical trials Reimbursement HIPAA DSMO 20 years, 2000 members 26 international affiliates “A model community”: building standards to a single information model

CDA Clinical Document Architecture ANSI/HL7 CDA R1.0-2000 CDA R2.0 to be published shortly created & maintained by HL7 Structured Documents Technical Committee (SDTC) 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 Release 2: Text + Observation <Section> <code code="10153-2" codeSystem="LOINC“> Past Medical History </code> <text>Patiënt met een voorgeschiedenis astma en hoge bloeddruk. Nu opgenomen in het ziekenhuis met een osteoartritis, rechter knie </text> <component1> <contextConductionInd value="TRUE"/> <Observation classCode=“COND”> <code code=”G-1001” codeSystem=”SNOMED” displayName=”Prior dx”/> <value code=”D1-201A8” codeSystem=”SNOMED” displayName=”Osteoarthritis”> <originalText><reference value=”#a3”/></originalText> </value> <targetSiteCode code=”T-15720” codeSystem=”SNOMED” displayName=”knee”> <qualifier> <name code=”G-C220” codeSystem=”SNOMED” displayName=”with laterality”/> <value code=”G-A100” codeSystem=”SNOMED” displayName=”right”/> </qualifier> </targetSiteCode> </Observation> </component1> </Section>

日本HL7協会情報教育担当リーダー 東芝住電医療情報システムズ（株） 村上 英 CDA R2の概要と適用検討例 日本HL7協会情報教育担当リーダー 東芝住電医療情報システムズ（株） 村上　英 2005.3.14 日本HL7協会　第18回HL7セミナー

CDA Widely implemented outside the US In the US most common application is transfer of care (Germany, Greece, Finland, Japan, Korea, Canada, Argentina) CDA transfer of care pilot in British Columbia (see CDA Implementation Guide for Vancouver Island Health Authority on SDTC web page) In the US CDA considered for HIPAA Claims Attachments (as payload in X12 message) Mayo: ramping up to 50,000 notes/week: investment in information as capital asset Columbia-Presbyterian: text and fielded data entry with natural language processing and controlled vocabulary Tricare Management Activity (DoD TMA) will implement CDA attachments supporting referrals management

CDA Specification is generic Human-readable “narrative block” Any document type Any clinical content Human-readable “narrative block” Defines legal content Displays with simple style sheet Required Machine-readable “clinical statements” Drives automated extraction, decision support…. Uses HL7 RIM, controlled vocabulary Optional

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

Creating CDA Document Types Add constraints to generic specification Designed for a community of users Scope: US Clinical applications: transfer of care Can be further specialized for closer communities Scope: Massachusetts Clinical application: pediatric Document coded to requirements of the document type Still valid against generic schema and specification

Validating CDA document types .xPath, .xsl, Schematron prose √ .xsd CRS .xml Validates against generic schema <Section code=Plan> √ XPath validation of Implementation Guide requirements

CDA & Incremental Semantic Interoperability Patients transfer between providers with vastly different IT capabilities Need to support information requirements at point of care Full EMR adoption… not predictable based on past adoption curves Assume gradually rising, but still heterogeneous levels of sophistication Data formats (imaging, text, XML) Coded data (metadata, basic structure, simple results reporting, complex clinical statements)

CDA & Incremental Semantic Interoperability Level 1: standardizes just the metadata (header) required for management Query, retrieve, file, track Full clinical content, but no coding requirements Target authoring: any (including imaging, fax) Level 2: Level 1 + standard structures (section, list, table titles) Clinical domain-specific Supports basic extraction, summary Target authoring: dictation, electronic text with template or minimal consistent structure

CDA & Incremental Semantic Interoperability Level 1: just the metadata (header) Level 2: Level 1 + structures Level 3: Level 2 + clinical statements (coded for machine processing) Expressive to full extent of Reference Information Model and vocabulary Target authoring: EMR, forms entry, natural language processing Many actual levels between these benchmarks A document can always exceed the required level of encoding

Clinical content invariant, regardless of level Same clinical content Level 1: XML, no codes Level 1: non-XML body Level 2: XML, section codes only the codes change

Let’s take a look…

Implementation Guides constrain coding Identical required section coding Not presentation Not narrative style Different optional narrative coding Two styles of presentation, one Implementation Guide

Implementation Guides constrain coding Not presentation Not narrative style Can impose uniform presentation, style but just for presentation the coding drives machine processing Distinction becomes more significant with Level 3

Current ballots & more… 3 1 4 2

Care Record Summary Implementation Guides for CDA Release 2 April 13, 2005 Keith W. Boone keith.boone@dictaphone.com Dictaphone Corporation

Thank you! Questions?