Introduction to the
Clinical Document Architecture
For the HL7 Child Health Work Group
Gay Giannone MSN, RN
June 10, 2009
www.alschulerassociates.com
Instructor
• Gay Giannone MSN, RN
– 20 years Neonatal Intensive Care Experience
– Masters in Nursing Administration and Healthcare Informatics
-University of Pennsylvania -2004
– Member HL7 SDWG
– CDA certified
– Primary editor on CDA Implementation Guides:
• QRDA
• Public Health Case Report
• Operative Note
– [email protected]
© Alschuler Associates, LLC, 2009
2
Objectives
• Basic understanding of CDA
• Understand relationship
between CDA, CCD, CRS
• Opportunities for pediatric work
in HL7
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3
Part 1 - Outline
• Overview of CDA
– Definition
– XML... and more
– Usage
– Let’s take a look...
• The “A” in CDA
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• The Specification
• Implementation
• Current Work, Summary & Resources
4
CDA History
• Clinical Document Architecture
• ANSI/HL7 CDA R1.0-2000
• ANSI/HL7 CDA R2.0-2005
• Created & maintained by HL7 Structured
Documents Work Group (SDWG)
• A specification for document exchange
using
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– 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
• and this
• and this
• and this
• and this
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• and this
6 6
CDA: What is a document?
• In XML-speak, everything is a
“document”
• Intuitively, documents:
– reflect historical form of healthcare
record
– mix discrete data and free-flowing
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narrative
• CDA restricts the set of healthcare
documents
7
The CDA document defined
CDA Release 2, section 2.1:
A clinical document ... has the following
characteristics:
Persistence
Stewardship
Potential for authentication
Context
Wholeness
Human readability
© Alschuler Associates, LLC, 2009
• therefore, CDA documents are not:
– data fragments, unless signed
– birth-to-death aggregate records
– electronic health records
8 8
CDA Design Principles
• priority is patient care, other applications
facilitated
• minimize technical barriers to
implementation
• promote longevity of clinical records
• scoped by exchange, independent of
transfer or storage
• enable policy-makers to control information
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requirements
9
Investing in Information
• CDA can be simple
• CDA 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
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– the greater the potential for reuse
10
Outline
• Overview of CDA
– Definition
– XML... and more
– Usage
– Let’s take a look...
• The “A” in CDA
© Alschuler Associates, LLC, 2009
• The Specification
• Implementation
• Current Work, Summary & Resources
11
CDA: XML
• XML is Extensible Markup Language
(www.w3c.org)
• In XML, structure & format are
conveyed by markup which is
embedded into the information
© Alschuler Associates, LLC, 2009
12 12
and why XML alone isn’t
enough
• With a few simple tags, and controlled
vocabulary, XML can describe anything
• but…
• the tags need to be defined:
<orderNum> : HL7: order placed
<orderNum> : CDISC: visit sequence
• CDA tags are defined by the HL7
© Alschuler Associates, LLC, 2009
Reference Information Model (RIM) and
use standard controlled vocabulary
13
Why isn’t XML + SNOMED enough?
“hives”: SNOMED CT 247472004
© Alschuler Associates, LLC, 2009
“Dr. Dolin asserts that Henry Levin
manifests hives as a previously-diagnosed
allergic reaction to penicillin”
14
First: human readable
<!--
********************************************************
Allergies & Adverse Reactions section
********************************************************
-->
<component>
<section>
<code code="10155-0" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" />
<title>Allergies and Adverse Reactions</title>
<text>
© Alschuler Associates, LLC, 2009
<list>
<item>Penicillin - Hives</item>
<item>Aspirin - Wheezing</item>
<item>Codeine - Itching and nausea</item>
</list>
</text>
15
Observation: RIM-defined
Next: series History: SNOMED
Hives: SNOMED
of coded Observation: RIM-defined
History : SNOMED
“clinical Allergy to penicillin: SNOMED
statements” Relationship: RIM-defined
RIM-defined CDA structures + vocabulary =
Hives manifests an allergic reaction to
penicillin
<entry>
<observation classCode="OBS" moodCode="EVN">
<code code="84100007" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT" displayName="history taking (procedure)" />
<value xsi:type="CD" code="247472004" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT" displayName="Hives" />
<entryRelationship typeCode="MFST">
<observation classCode="OBS" moodCode="EVN">
<code code="84100007" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT" displayName="history taking (procedure)" />
<value xsi:type="CD" code="91936005" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT" displayName="Allergy to penicillin" />
</observation>
</entryRelationship>
© 2006 Health Level Seven ®, Inc. All Rights Reserved. HL7
and Health Level Seven are registered trademarks of Health
</observation> Level Seven, Inc. Reg. U.S. Pat & TM Off
</entry>
<!-- Then: supply context
********************************************************
CDA Header
********************************************************
-->
<id extension="c266" root="2.16.840.1.113883.3.933" />
<code code="11488-4" codeSystem="2.16.840.1.113883.6.1" displayName="Consultation note" />
<title>Good Health Clinic Consultation Note</title>
<effectiveTime value="20000407" />
<confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25" />
<setId extension="BB35" root="2.16.840.1.113883.3.933" />
<versionNumber value="2" />
+<legalAuthenticator>
+<author>
Who is the subject?
+<custodian>
<recordTarget> Target: RIM-defined
<patient>
<id extension="12345" root="2.16.840.1.113883.3.933" /> Id: local
<patientPatient>
<name>
<given>Henry</given>
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<family>Levin</family>
<suffix>the 7th</suffix>
</name>
<administrativeGenderCode code="M" codeSystem="2.16.840.1.113883.5.1" />
<birthTime value="19320924" />
</patientPatient>
<providerOrganization>
<id extension="M345" root="2.16.840.1.113883.3.933" />
</providerOrganization>
</patient>
</recordTarget> 17
Relationship to HL7 messages
• CDA complements HL7 messaging
specs
• A CDA document is a defined and
complete information object that can
exist outside of a messaging context
• A CDA document can be a MIME-
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encoded payload within an HL7
message
18
Relationship to HL7 messages
CDA documents are encapsulated as MIME packages within HL7 messages HL7 V3
<someMessage>
<Act.Code code="11488-4“ codeSystem="2.16.840.1.113883..."
displayName="Consultation note"/>
HL7 V2.x <Act.text type="multipart/related">
MIME-Version: 1.0
Content-Type: multipart/related; boundary="HL7-CDA-
MSH|... boundary"; type="text/xml"; start="10.12.45567.43"
Content-Transfer-Encoding: BASE64 --HL7-CDA-boundary
EVN|... Content-Type: text/xml; charset="US-ASCII“ Content-ID:
<10.12.45567.43>
PID|... ... Base 64 of base CDA document, which contains ...
PV1|... <observationMedia classCode="OBS" moodcode="EVN">
<id root="10.23.4567.345"/>
TXA|... <value mediaType="image/jpeg">
<reference value="left_hand_image.jpeg"/>
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OBX|1|ED|... </value>
</observationMedia> ...
--HL7-CDA-boundary
Content-ID: <10.23.4567.345>
Content-Location: canned_left_hand_image.jpeg
Content-Type: image/JPEG
... Base64 image ...
|... --HL7-CDA-boundary--
</Act.text>
</someMessage> 19
Primary Use Cases
• access/portability/exchange
– query/locate by patient, provider, practitioner,
setting, encounter, date
– access distributed information through common
metadata
– document management
• integration
– transcription systems
– EHR records
© Alschuler Associates, LLC, 2009
• re-use/derivative data
– summaries, reports
– decision support
20
Outline
• Overview of CDA
– Definition
– XML... and more
– Usage
– Let’s take a look...
• The “A” in CDA
© Alschuler Associates, LLC, 2009
• The Specification
• Implementation
• Current Work, Summary & Resources
21
CDA = header + body
• CDA Header
– Metadata required for document
discovery, management, retrieval
• CDA Body
– Clinical report
• Discharge Summary
• Care Record Summary
• Progress Note
© Alschuler Associates, LLC, 2009
• H&P
• Public health report
– … any content that carries a signature
22
CDA Header: Metadata
• Identify
– Patient
– Provider
– Document type...
required
• Sufficient for
© Alschuler Associates, LLC, 2009
– Medical records management
– Document management
– Registry/repository
– Record locator service
– Store, query, retrieve
23
CDA
• Specification is generic
– Any document type
– Any clinical content
• Simplest body: non-XML
• XML body
– Human-readable “narrative block”
• Defines legal content
• Displays with simple style sheet
• Required
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– Machine-readable “clinical statements”
• Drives automated extraction, decision support….
• Uses HL7 RIM, controlled vocabulary
• Optional
24
CDA Body: Human-readable report
• Any type of clinical document
– H&P
– Consult
– Op note
– Discharge Summary...
• Format: tif, PDF, HTML, XML:
– Paragraph
– List
– Table
– Caption
© Alschuler Associates, LLC, 2009
– Link
– Content
– Presentation
required
25
26
Non-XML CDA Body
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CDA Body: Machine
Processible
– Model-based computable semantics:
• Observation
• Procedure
• Organizer
• Supply Optional
• Encounter
• Substance Administration
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• Observation Media
• Region Of Interest
• Act
27
CDA: Incremental Semantic
Interoperability
• Standard HL7 metadata
• Simple XML for point of
care human readability
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• RIM semantics for reusable
computability (“semantic
interoperability”)
28
Outline
• Overview of CDA
• The “A” in CDA
– Levels
– Scalability: simple to complex
• The Specification
• Implementation
© Alschuler Associates, LLC, 2009
• Current Work, Summary & Resources
29
The CDA Architecture
• What is the unit of standardization?
– data element: too narrow
– longitudinal record: too broad
– document: just right
• One document standard or many?
– can’t put everything into a single spec
– how to coordinate multiple specs?
• CDA architecture:
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– generic pattern with rigorous metadata
– specialize/constrain clinical body per
document type
30
Outline
• Overview of CDA
• The “A” in CDA
– Levels
– Scalability: simple to complex
• The Specification
• Implementation
© Alschuler Associates, LLC, 2009
• Current Work, Summary & Resources
31
CDA Levels
Levels are distinguished by:
granularity of machine-processible markup
Level One -- Body is human-readable, no semantic codes.
– Level Two -- Instances with machine-processible section-level
semantics.
– Level Three -- Instances that have at least some clinical
statements, expressions that are machine-processible to the
extent that can be modeled in the RIM.
• All levels validate against the generic CDA schema.
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Additional validation can be provided by templates and
constraints on the generic schema.
32
Release 2: Levels One, Two, Three
<Section>
<code code="10153-2" codeSystem="LOINC“>
Past Medical History
</code> Level 2
human
<text><list>
<item><content>Asthma</content></item>
Level 1
<item><content>Hypertension</content></item>
readable
<item><content ID=“a3”>Osteoarthritis, right knee</content></item>
</list></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”>
machine processible
<originalText><reference value=”#a3”/></originalText>
</value>
<targetSiteCode code=”T-15720” codeSystem=”SNOMED”
displayName=”Knee joint”>
Level 3
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<qualifier>
<name code=”G-C220” codeSystem=”SNOMED”
displayName=”with laterality”/>
<value code=”G-A100” codeSystem=”SNOMED” displayName=”right”/>
</qualifier>
<originalText><reference value=”#a4”/></originalText>
</targetSiteCode>
</Observation>
</component1>
</Section> 33
What an architecture
provides:
• Information can be encoded at
varying levels of specificity and
understood at the highest, or most
appropriate, level of encoding
• Information encoded at varying
levels can be analyzed at the
highest common level
• Introduces the concept of
© Alschuler Associates, LLC, 2009
“incremental or variable semantic
interoperability”
34
Outline
• Overview of CDA
• The “A” in CDA
– Document types
– Levels
– Scalability: simple to complex
• The Specification
© Alschuler Associates, LLC, 2009
• Implementation
• Current Work, Summary & Resources
35
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
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– Data formats (imaging, text, XML)
– Coded data (metadata, basic structure, simple
results reporting, complex clinical statements)
36
CDA Business Case
•CDA hits the “sweet spot” – CDA
encompasses all of clinical documents. A
single standard for the entire EHR is too broad.
Multiple standards and/or messages for each
EHR function may be difficult to implement.
CDA is “just right”.
•Implementation experience - CDA has been an ANSI standard since
2000, and has been balloted through HL7's consensus process. CDA is
widely implemented.
•Gentle on-ramp to information exchange - CDA is straight-forward to
implement, and provides a mechanism for incremental semantic
interoperability.
© Alschuler Associates, LLC, 2009
•Improved patient care - CDA provides a mechanism for inserting
best practices and evidence-based medicine directly into the process of
care (via the same “template” mechanism used to build CCD), thereby
making it easier to do the right thing.
•Lower costs – CDA’s top down strategy let’s you implement once, and
reuse many times for new scenarios.
37 37
Investing in Information
• Dissecting the curve
cost • What is easy:
– Header
– Human-readable body
– Low degree of coding
80/20 • What is hard:
– Concensus on
√ semantic content
© Alschuler Associates, LLC, 2009
requirements
benefit – Model/vocabulary
interface
38
Outline
• Overview of CDA
• The “A” in CDA
• The Specification
• Implementation
• Relationship: CDA, CCD, CCR
• Current Work, Summary & Resources
© Alschuler Associates, LLC, 2009
39
Creating CDA Document
Types
• Add constraints to generic specification
• Designed for a community of users
– Scope: US
– Clinical applications: transfer of care, H&P
• Can be further specialized for closer
communities
– Scope: Massachusetts
– Clinical application: pediatric
• Document coded to requirements of the
© Alschuler Associates, LLC, 2009
document type
• Still valid against generic schema and
specification
40
CDA IGs Balloted through HL7
– Continuity of Care Document:
• Implements ASTM CCR as CDA
• Establishes reusable templates for common types of entries
– CDA4CDT (Health Story):
• History & Physical
• Consult Note
• Diagnostic Imaging Report
• Operative Report
– Healthcare Associated Infection Reports
• Sponsored by CDC
• Reporting to NHSN
• 12 report types published, to-date; 2 more in ballot
– Personal Health Monitoring
• Sponsored by Continua Health Alliance
• Adopted by HITSP
– Quality Reporting Document Architecture – HL7 Peds WG co-sponsor
• Prototyped in NHIN demonstrations
• Patient-level data reports are initial category of reporting
– Plan to Plan Personal Health Record Transfer
• Passed ballot
• Sponsored by AHIP/BCBSA
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– Minimum Data Set for Long Term Care Reporting
• Passed ballot
• Sponsored by broad range of public and private agencies
– Public Health Case Reports to CDC
• Passed as Informative Document - In ballot reconciliation
– Care Record Summary: Summarization note supporting transfer of
care, superseded by CCD
41
Implementation Guides constrain coding
• Not presentation
• Not narrative style
• Implementers can impose uniform
presentation, style
– but just for presentation
– the coding drives machine processing
© Alschuler Associates, LLC, 2009
• Distinction becomes more
significant with Level 3
42
Sample Conformance Statements
• SHALL contain 1..1 @classCode = OBS "Observation" (CodeSystem:
2.16.840.1.113883.5.6 HL7ActClass) STATIC (CONF: 437).
• SHALL contain 1..1 @moodCode = EVN "Event" (CodeSystem:
2.16.840.1.113883.5.1001 HL7ActMood) STATIC (CONF: 438).
• MAY contain 0..1 @negationInd (CONF: 1284).
• SHALL contain 1..1 code = 11341-5 "History of occupation"
(CodeSystem: 2.16.840.1.113883.6.1 LOINC) STATIC (CONF: 439).
• MAY contain 0..1 text (CONF: 442).
• SHALL contain 1..1 statusCode = completed (CodeSystem:
2.16.840.1.113883.5.14 HL7ActStatus) STATIC (CONF: 440).
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• SHOULD contain 0..1 effectiveTime (CONF: 443).
• SHALL contain 1..1 value (CD), which SHALL be selected from
ValueSet 2.16.840.1.114222.4.11.887 Occupation DYNAMIC
(CONF: 441).
43
Outline
• Overview of CDA
• The “A” in CDA
• The Specification
• Implementation
• Relationship: CDA, CCD, CCR
• Current Work, Summary & Resources
© Alschuler Associates, LLC, 2009
44
CDA: How to Create
• Creating CDA documents
– scan or text file
– transcription
– eForms
– desktop applications
– EHR
– DICOM Structured Report transform
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45
The Simplest CDA
Inherit
patient
context
© Alschuler Associates, LLC, 2009
Enter
Point to
minimal
document
metadata
body
46
CDA: How to Manage
• Clinical Data Repository?
• Custom Database?
• Good old file system?
• Document management system?
• Personal health record?
© Alschuler Associates, LLC, 2009
47
CDA: How to Distribute
• There are many ways to distribute CDA
documents.
– Fax
– Sneaker-net
– Email
– X12
– HL7 messaging
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– Custom Web Services (SOAP, XML-RPC,
REST)
– XDS
48
Outline
• Overview of CDA
• The “A” in CDA
• The Specification
• Implementation
• Relationship: CDA, CCD, CCR
• Current Work & Resources
© Alschuler Associates, LLC, 2009
49
The ABC’s of CDA
Added domain Added domain
Rules from CCR
rules Rules
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H&P CCD QRDA PHCR
50
ASTM CCR+HL7 CDA = CCD
• The primary use case for the ASTM CCR is to provide a snapshot in time
containing a summary of the pertinent clinical, demographic, and
administrative data for a specific patient.
• From its inception, CDA has supported the ability to represent professional
society recommendations, national clinical practice guidelines, standardized
data sets, etc.
© Alschuler Associates, LLC, 2009
•From the perspective of CDA, the ASTM CCR is a standardized data set
that can be used to constrain CDA specifically for summary documents.
•The resulting specification is known as the Continuity of Care Document
(CCD).
51
Outline
• Overview of CDA
• The “A” in CDA
• The Specification
• Implementation
• Relationship: CDA, CCD, CCR
• Current Work & Resources
© Alschuler Associates, LLC, 2009
52
CDA beyond CCD
• Not everything we want to exchange
is a CCD Transfer of Care Summary
– H&P, Consult, other doc types
– summaries that specialize CCD
• Let’s look at what’s happening with
© Alschuler Associates, LLC, 2009
development of other document
types...
53
Get involved to ensure
pediatric needs:
• Participate in design review
– through HL7 Structured Documents WG
– weekly calls, at working group meetings
• Participate in the ballot
– as HL7 member or non-member
• Encourage implementation
© Alschuler Associates, LLC, 2009
– from your vendor
– within professional society
– within practice group
54
The Health Story Project
• Project initiated in January, 2007
– M*Modal
– AHDI(was AAMT)/MTIA
– AHIMA
• Strong support from dictation /
transcription and document
© Alschuler Associates, LLC, 2009
management industries
• Cooperation/coordination with HL7,
IHE, EHR vendors and providers
55
Health Story Mission
• Develop CDA Implementation Guides
(IGs) for common types of electronic
healthcare documents
• Bring them through the HL7 ballot
process
• Promote their use and adoption by
© Alschuler Associates, LLC, 2009
healthcare organizations and health
information exchange networks
56
Rationale
• Enlarge and enrich the flow of data
into the electronic health record
• Speed the development of
interoperable clinical document
repositories
• Bridge the gap between narrative
documents produced through
© Alschuler Associates, LLC, 2009
dictation and the structured,
computable records within an EHR
57
Project Members
Founders
Promoters
© Alschuler Associates, LLC, 2009
Participants
58
CDA for Collaborative Care
• Health Story:
– Consult Report, Operative Note
– Diagnostic Imaging Reports with DICOM
• Continua Health Alliance: Personal
Health Monitoring
• CMS Minimum Data Set
• Plan to Plan Personal Health
© Alschuler Associates, LLC, 2009
Record
• IHE Profiles: variants on H&P, many
additional types
59
CDA for Secondary Usage: Analysis,
Reporting
• Public Health:
– Healthcare Associated Infection Reports
• Centers for Disease Control and Prevention National
Health Safety Network
– Case Reporting
• CDC National Center for Public Health Informatics
– Cancer Abstract submission
• North American Association of Central Cancer
Registries
• Quality:
© Alschuler Associates, LLC, 2009
– Quality Reporting Document Architecture
• More in the works
60
Investing in Information: phased approach
• Lay groundwork
– CDA header metadata
– XML R1 or R2 CDA body
• Build
– Consensus on requirements
– Understanding of modeling process
– Vocabulary glossary
• Understand
© Alschuler Associates, LLC, 2009
– Relationship of vocabulary to model
• Introduce interoperable semantic content as
requirements and business drivers dictate
61
Current SDWG work
• Last cycle:
– Generic Structured Documents domain
– Public Health Case Reports
– Additional Healthcare Associated Infection Reports
• Future:
– Generic CDA for Reporting, Additional Public Health
Case Reports
– further work with domain committees
• Anesthesiology
• Genomics
– Update CCD
– CDA R3: target 2010 ballot
© Alschuler Associates, LLC, 2009
62
CDA R3 Preview
• CDA R3
• Schedule
– Requirements gathering: 2009
– Ballot: For comment January 2010
– Publish: End 2010 ?
• Issues
– Adopt Clinical Statement model
• Sufficiently tested? Mature? Implemented?
• Will the CS model be adopted by the HL7 domain
committees?
– Adopt the RIM
• How to maintain consistency and simplicity?
© Alschuler Associates, LLC, 2009
– Backward compatibility
• Same principles as R1-R2
• Larger body of existing work
• Now, includes detailed clinical data
63
Current ballots & more…
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NOW: listservs for Thursdays 10-12 ET
both CDA and Open to all
CCD Subscribe and call
into weekly SDWG
meetings
770-657-9270
310940#
64
Available to HL7 members
• CDA Normative Edition: Web
publication
© Alschuler Associates, LLC, 2009
65
Quick Start Guides
• CDA – available now
• CCD – available now
Prose
Examples in text
Unpopulated sample
© Alschuler Associates, LLC, 2009
66
JAMIA
References
Dolin RH, Alschuler L, Boyer S, Beebe C, Behlen FM, Biron PV, Shabo A. HL7 Clinical Document
Architecture, Release 2. J Am Med Inform Assoc. 2006;13:30–39.
http://www.jamia.org/cgi/reprint/13/1/30
• CDA Release 2.0 Normative Edition: see HL7.org
• CCD: see HL7.org
• V3 Normative Edition
http://www.hl7.org/v3ballot/html/welcome/environment/index.htm
• XML
http://www.w3.org/TR/xml
• XSLT
http://www.w3.org/TR/xslt
• XHTML
http://www.w3.org/TR/xhtml-modularization/
• Schematron
© Alschuler Associates, LLC, 2009
http://www.schematron.com/
http://xml.ascc.net/resource/schematron/schematron.html
AlschulerAssociates.com
– Quick Start Guides
– CDA Validator
– CDA Gallery
–
[email protected] –
[email protected] 67
Questions?
Thank you!
68
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