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HL7 Standards
Nawanan Theera-Ampornpunt, M.D., Ph.D.
Department of Community Medicine
Faculty of Medicine Ramathibodi Hospital
Certified HL7 CDA Specialist
Some slides reproduced & adapted with permission from
Dr. Supachai Parchariyanon
September 15, 2016
2
»Profile:
Dr. Supachai Parchariyanon is a medical doctor
who’s passionate about information technology and
turn himself to be informatician and serial
entrepreneurs.
He’s also earned Business Management degree
from Ramkamhaeng university and Biomedical
Informatics degree from the US. He led the team to
certify both HL7 Reference Information Model (RIM)
and Clinical Document Architecture (CDA). His
interest is now on standards and interoperability,
clinical informatics and project management.
»Keep in touch
»supachaimd@gmail.com
»http://www.facebook.com/supachaiMD
Supachai Parchariyanon
@supachaiMD
Slide reproduced/adapted from Dr. Supachai Parchariyanon
3
Nawanan Theera-Ampornpunt
2003 M.D. (Ramathibodi)
2009 M.S. in Health Informatics (U of MN)
2011 Ph.D. in Health Informatics (U of MN)
2012 Certified HL7 CDA Specialist
Former Deputy Chief, Informatics Division
Deputy Executive Director for Informatics,
Chakri Naruebodindra Medical Institute
Faculty of Medicine Ramathibodi Hospital
nawanan.the@mahidol.ac.th
http://groups.google.com/group/ThaiHealthIT
Research interests:
• EHRs & health IT applications in clinical settings
• Health IT adoption
• Health informatics education & workforce development
4
Outline
• Introduction to Standards & Interoperability
• What is Health Level Seven (HL7)?
• What HL7 does?
• HL7 Version 2
• HL7 Version 3 Messaging Standard
• Reference Information Model (RIM)
• Clinical Document Architecture (CDA)
Slide reproduced/adapted from Dr. Supachai Parchariyanon
5
Standards Are Everywhere
6
Standards: Why?
• The Large N Problem
N = 2, Interface = 1
# Interfaces = N(N-1)/2
N = 3, Interface = 3
N = 5, Interface = 10
N = 100, Interface = 4,950
7
Health Information Exchange (HIE)
Hospital A Hospital B
Clinic C
Government
Lab Patient at Home
8
Objectives
• Interoperability
• Inter-operable
systems
Ultimate Goals
• Continuity of Care
• Quality
 Safety
 Timeliness
 Effectiveness
 Equity
 Patient-Centeredness
 Efficiency
Why Health Information Standards?
9
Levels of Interoperability
Functional
Semantic
Syntactic
10
Various Kinds of Standards
• Unique Identifiers
• Standard Data Sets
• Vocabularies & Terminologies
• Exchange Standards
– Message Exchange
– Document Exchange
• Functional Standards
• Technical Standards: Data Communications,
Encryption, Security
11
Functional
Semantic
Syntactic
How Standards Support Interoperability
Technical Standards
(TCP/IP, encryption,
security)
Exchange Standards (HL7 V2,
HL7 V3 Messaging, HL7 CDA,
DICOM)
Vocabularies, Terminologies,
Coding Systems (ICD-10, ICD-9,
CPT, SNOMED CT, LOINC)
Information Models (HL7 V3 RIM,
ASTM CCR, HL7 CCD)
Standard Data Sets
Functional Standards (HL7 EHR
Functional Specifications)
Some may be hybrid: e.g. HL7 V3, HL7 CCD
Unique ID
12
What is HL7?
• HL7 is an ANSI-accredited Standards
Development Organization (SDO)
operating in the healthcare arena.
• It is a non-profit organization made up of
volunteers – providers, customers,
vendors, government, etc.
Slide reproduced/adapted from Dr. Supachai Parchariyanon
13
What is HL7? (Cont.)
• HL7 is an acronym for Health Level Seven
– Seven represents the highest, or “application”
level of the International Standards
Organization (ISO) communications model for
Open Systems Interconnection (OSI) networks.
Slide reproduced/adapted from Dr. Supachai Parchariyanon
14
OSI Model
Slide reproduced/adapted from Dr. Supachai Parchariyanon
15
What HL7 does?
• HL7 focuses on the clinical and administrative
data domains.
• It defines data exchange standards for these
domains called messages or messaging
specifications (aka HL7 messages)
– Messages are developed by technical committees and
special interest groups in the HL7 organization.
• HL7 organization defines 2 versions of the
messaging standard:
– HL7 v2.x (syntactic only)
– HL7 v3.0 (semantic capability added)
Slide reproduced/adapted from Dr. Supachai Parchariyanon
16
What HL7 does?
Slide reproduced/adapted from Dr. Supachai Parchariyanon
17
HL7 Standards
• HL7 V2.x
– Defines electronic messages supporting hospital
operations
• HL7 V3
• HL7 Clinical Document Architecture
(CDA) Releases 1 and 2
• HL7 Arden Syntax
– Representation of medical knowledge
• HL7 EHR & PHR Functional Specifications
• Etc.
18
The Industry Standard
HL7 Version 2 (HL7 V2)
• Not “Plug and Play” - it provides 80 percent of the
interface and a framework to negotiate the remaining 20
percent on an interface-by-interface basis
• Historically built in an ad hoc way because no other
standard existed at the time
• Generally provides compatibility between 2.X versions
• Messaging-based standard built upon pipe and hat
encoding
• In the U.S., V2 is what most people think of when people
say “HL7″
Slide reproduced/adapted from Dr. Supachai Parchariyanon
19
HL7 version2
• HL7 V2 is still the most commonly used HL7
standard
– Over 90% of US hospitals have implemented some
version of 2.x HL7 messages
• The HL7 V2 messaging standard is considered:
– The workhorse of data exchange in healthcare
– The most widely implemented standard for healthcare
information in the world
• HL7 V2.5 was approved as an ANSI standard in
2003
• HL7 is currently working on version 2.7
Slide reproduced/adapted from Dr. Supachai Parchariyanon
20
HL7 V2 Message
• Composed of reusable segments, each
identified by a 3-letter mnemonic
• All messages must start with header segment
MSH which includes sender, receiver, date-
time, message identifier, message type, and
trigger event
• Segments used in a message are determined
by message type
Slide reproduced/adapted from Dr. Supachai Parchariyanon
21
Part of Sample HL7 V2 Message
(Lab Result)
OBX|1|NM|10839-9^TROPONIN-I^LN||5|ng/ml|
0-1.3|H||H|F|19980309…
22
HL7 Basic Transaction Model
send
HL7 ADT
A01 msg
receive HL7
ACK msg
ADT system
Lab system
Receive A01,
send ACK
(external) admit
event
trigger event
network
Slide reproduced/adapted from Dr. Supachai Parchariyanon
23
Patient Admission Scenario,
Inform Lab System
• Trigger event is admission : A01
• Message type is: ADT
• Messages composed of:
– MSH (message header)
– PID (patient identification)
– PV1 (visit data)
Slide reproduced/adapted from Dr. Supachai Parchariyanon
24
HL7 V2 Message
• Messages composed of
– Segments composed of
• Fields composed of
– Components
• Delimiters
– Field separator: |
– Component separator: ^
– Repetition separator: ~
– Escape character: 
– Subcomponent: &
– Segment terminator: <cr>
Slide reproduced/adapted from Dr. Supachai Parchariyanon
25
Message Header Segment - MSH
MSH|^~|&|SMS|OR2|TMR|SICU|201010191535|password|ADT^A01|MSG1632|P|2.7<cr>
Sending
Unit
Receiving
Unit Date
Time
Message
type
Trigger
ID
Sending
Place Receiving
Place
Message
Number
version
Delimiters
production
Slide reproduced/adapted from Dr. Supachai Parchariyanon
26
PID Segment – 1/3
PID|Z12345^5^M11||||PATIENT^JOSEPH^M^IV|
Patient ID
Check digit
Method
Last name
First name
Middle
Initial
Suffix
Patient name
Null fields
Data field
Field delimiter
Slide reproduced/adapted from Dr. Supachai Parchariyanon
27
PID Segment – 2/3
MAIDEN|19610605|M||C|1492 OCEAN STREET^
Mother’s
maiden name
Gender
Date of birth Race
Street
address
Data component Component
delimiter
Slide reproduced/adapted from Dr. Supachai Parchariyanon
28
PID Segment – 3/3
DURHAM^NC^27705|DUR|(919)684-6421<cr>
City
State
Zip Code
County
Telephone
Segment terminator
Slide reproduced/adapted from Dr. Supachai Parchariyanon
29
PV1 Segment
PV1|1|1|N2200^2200|||OR^02|0846^WELBY^MARCUS^G||SUR<cr>
Patient location
Attending
Service
Sequence
number
Patient
class
Slide reproduced/adapted from Dr. Supachai Parchariyanon
30
Summary
Slide reproduced/adapted from Dr. Supachai Parchariyanon
31
Rules
Slide reproduced/adapted from Dr. Supachai Parchariyanon
32
Problems with HL7 v2
• HL7 v2 cannot support all this!
– Ad Hoc design methodology
– Ambiguous – lacking definition
– Complicated, esoteric encoding rules.
– Artifacts left to retain backward compatibility
– Too much optionality
– Can’t specify conformance
– No standard vocabulary
Slide reproduced/adapted from Dr. Supachai Parchariyanon
33
What’s Different About V3?
• Conceptual foundation
– A single, common reference information model to be used across
HL7
• Semantic foundation
– Explicitly defined concept domains drawn from the best
terminologies
• Abstract design methodology
– That is technology-neutral
– Able to be used with whatever is the technology de jour
• XML, UML, etc.
• Maintain a repository
– Database of the semantic content
– Ensures a single source and enable development of support
tooling
Slide reproduced/adapted from Dr. Supachai Parchariyanon
34
How is V3 different than V2?
• V3 is approaching “Plug and Play”
• V2 uses pipe and hat messaging, while V3
uses the Reference Information
Model(RIM) and XML for messaging
• V3 is a brand new start – it is NOT
backward compatible with V2
Slide reproduced/adapted from Dr. Supachai Parchariyanon
35
HL7 V3 Standards
• A family of standards based on V3
information models and development
methodology
• Components
– HL7 V3 Reference Information Model (RIM)
– HL7 V3 Messaging
– HL7 Development Framework (HDF)
36
How HL7 V3 Works
• Message sent from sending application to
receiving application
• Mostly triggered by an event
• Typical scenario portrayed in a storyboard
• Message in XML with machine-processable
elements conforming to messaging
standard
• Data elements in message conform to RIM
• Not designed for human readability
37
V3 Messaging Standard
• Based on an object information model, called the
Reference Information Model, (RIM)
– This model is “abstract,” that is, it is defined without
regard to how it is represented in a message “on the
wire” or in a “service architecture” method or in a
“clinical document”
– In fact, each of these representations can contain the
same “instance” of information
• Consequently, can be extended incrementally
when new clinical information domains need to
be added, in a way that doesn’t require changing
what has already been created
Slide reproduced/adapted from Dr. Supachai Parchariyanon
38
HL7 V3 Messaging
• V3 provides messaging standards for
– Patient administration
– Medical records
– Orders
– Laboratory
– Claims & Reimbursement
– Care provision
– Clinical genomics
– Public Health
– Etc.
39
Sample HL7 V3 Message
(Patient Registration)
<?xml version="1.0" encoding="UTF-8"?>
<PRPA_IN101311UV02 xmlns="urn:hl7-org:v3"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
ITSVersion="XML_1.0" xsi:schemaLocation="urn:hl7-org:v3
../schemas/PRPA_IN101311UV02.xsd">
...
<name use="SYL" >
<given>นวนรรน</given>
<family>ธีระอัมพรพันธุ์</family>
</name>
<name use="ABC">
<given>Nawanan</given>
<family>Theera-Ampornpunt</family>
</name>
<administrativeGenderCode code="M"/>
...
</PRPA_IN101311UV02>
Message source adapted from Ramathibodi HL7 Project by Supachai Parchariyanon,
Kavin Asavanant, Sireerat Srisiriratanakul & Chaiwiwat Tongtaweechaikit
40
HL7 V3 Reference
Information Model
• Referral
• Transportation
• Supply
• Procedure
• Consent
• Observation
• Medication
• Administrative act
• Financial act
• Organization
• Place
• Person
• Living Subject
• Material
• Patient
• Member
• Healthcare facility
• Practitioner
• Practitioner assignment
• Specimen
• Location
Entity
0..*
1
Role
1
0..*
1
0..*
Act
Relationship
1..*
10..*
1
Participation Act
• Author
• Reviewer
• Verifier
• Subject
• Target
• Tracker
• Has component
• Is supported by
Slide reproduced/adapted from Dr. Supachai Parchariyanon
41
HL7 V3 Components and Process:
RIM UML Instance Scenario
 Classes are color coded:
 Green = Entity, Yellow = Role, Blue = Participation, Red/Pink = Act, Purple = Infrastructure, Lilac = message
controller.
John Doe Patient Subject
Entity Role Participation Act
Dr. Smith
HealthCare
Provider
Surgeon
John Doe Patient Subject
Has Pertinent
InformationAct Relationship
(Clinical Trial Act)
Protocol ECOG
1112
XYZ
Hospital
HealthCare
Facility
Location
(Procedure Act)
Prostectomy
Slide reproduced/adapted from Dr. Supachai Parchariyanon
42
Reference Information Model (RIM)
Slide reproduced/adapted from Dr. Supachai Parchariyanon
43
Source: “What is CDA R2? by Calvin E. Beebe
at HL7 Educational Summit in July 2012
44
The HL7 V3 Solution
• Approaching “Plug and Play” - less of a
“framework for negotiation”
• Utilizes RIM for data model
• Utilizes XML as transport method
• HL7 V3 is not the next release of HL7 V2 -
It is a paradigm shift
Slide reproduced/adapted from Dr. Supachai Parchariyanon
45
The HL7 V3 Solution (Cont.)
• HL7 V3 addresses the problems of HL7 V2
by:
– Reducing HL7 V2 optionality
– Including testable conformance rules
• HL7 V3 is based on a formal development
methodology:
– Follows an Object Oriented (OO) approach
– Uses Universal Modeling Language (UML) principles
• Most importantly, HL7 V3 supports
semantic interoperability
Slide reproduced/adapted from Dr. Supachai Parchariyanon
46
Interoperability in HL7 V3
• The Four Pillars of Semantic
Interoperability in HL7 V3
– A common Reference Information Model (RIM) which
spans the entire patient care, administrative and
financial healthcare universe
– A well-defined and tool-supported process for deriving
data exchange specifications ("messages") from the
RIM
– A formal and robust Data Type Specification upon
which to ground the RIM
– A formal methodology for binding concept-based
terminologies (vocabulary) to RIM attributes
Slide reproduced/adapted from Dr. Supachai Parchariyanon
47
HL7 Model Repository
• Database holding the core of HL7
semantic specifications
– RIM
– Storyboards
– Vocabulary domains
– Interaction models
– Message designs
– Message constraints
Slide reproduced/adapted from Dr. Supachai Parchariyanon
48Slide reproduced/adapted from Dr. Supachai Parchariyanon
49
Navigating the V3 Ballot
Publication
Slide reproduced/adapted from Dr. Supachai Parchariyanon
50
Navigating the V3 Ballot
Publication
• Domains: The Functional Content of the
Publication
– Universal Realm Domains
• Administration Domains
• Health and Clinical Practice Domains
• Common Use Domains
– US Realm domains
• Medicaid Information Technology Architecture
(MITA)
– Other realm specific domains..
Slide reproduced/adapted from Dr. Supachai Parchariyanon
51
Domain Publication
Structure
Each Realm contains a collection of
Domains. Domains are further divided into
Topics
• Domain
• Topic
Slide reproduced/adapted from Dr. Supachai Parchariyanon
52
V3 Messaging Concerns
• Difficult to implement
• No one understands V3
• Overhead too much
– 1% of message is payload compared to V2
(delimiters) is about 90-95%
• No one understands what implementation of V3
messaging means
• Need stability, clarity, definition of V3 messaging
Slide reproduced/adapted from Dr. Supachai Parchariyanon
53
The Future of HL7
• FHIR: Fast Healthcare Interoperability
Resources
– Pronounced “Fire”
• FHIR defines a set of “Resources” that
represent granular clinical concepts, which
can be managed in isolation, or
aggregated into complex documents
• Resources are based on simple XML or
JSON structures, with an http-based
RESTful protocol
http://wiki.hl7.org/index.php?title=FHIR
54
HL7 Clinical Document
Architecture (CDA)
Nawanan Theera-Ampornpunt, M.D., Ph.D.
Department of Community Medicine
Faculty of Medicine Ramathibodi Hospital
Certified HL7 CDA Specialist
Some slides reproduced & adapted with permission from
Dr. Supachai Parchariyanon
55
Message Exchange
• Goal: Specify format
for exchange of data
• Internal vs. external
messages
• Examples
 HL7 V2
 HL7 V3 Messaging
 DICOM
 NCPDP
Document Exchange
• Goal: Specify format
for exchange of
“documents”
• Examples
 HL7 V3 Clinical Document
Architecture (CDA)
 ASTM Continuity of Care
Record (CCR)
 HL7 Continuity of Care
Document (CCD)
Exchange Standards
56
Messages
• Human Unreadable
• Machine Processable
Clinical Documents
• Human Readable
• (Ideally) Machine
Processable
Exchange Standards
57
Hospital A Hospital B
Clinic C
Government
Lab Patient at Home
Message Exchange
Message
Message
Message
Message
Message
58
Hospital A Hospital B
Clinic C
Government
Lab Patient at Home
Clinical Document Exchange
Message containing
Referral Letter
Message containing
Claims Request
Message containing
Lab Report
Message containing
Patient Visit Summary
Message containing
Communicable
Disease Report
59
What Is HL7 CDA?
• “A document markup standard that
specifies structure & semantics of “clinical
documents” for the purpose of exchange”
[Source: HL7 CDA Release 2]
• Focuses on document exchange, not
message exchange
• A document is packaged in a message
during exchange
• Note: CDA is not designed for document
storage. Only for exchange!!
60
What is CDA?
• CDA is based on XML
• XML is eXtensible Markup Language
• In XML, structure & format are conveyed
by markup which is embedded into the
information
Slide reproduced/adapted from Dr. Supachai Parchariyanon
61
Clinical Document
Slide reproduced/adapted from Dr. Supachai Parchariyanon
62
A Clinical Document (1)
• A documentation of clinical observations
and services, with the following
characteristics:
 Persistence - continues to exist in an
unaltered state, for a time period defined by
local and regulatory requirements
 Stewardship - maintained by an organization
entrusted with its care
 Potential for authentication - an assemblage
of information that is intended to be legally
authenticated Source: HL7 CDA R2
63
A Clinical Document (2)
• A documentation of clinical observations
and services, with the following
characteristics:
 Context - establishes the default context for its
contents; can exist in non-messaging contexts
 Wholeness - Authentication of a clinical
document applies to the whole and does not
apply to portions of the document without full
context of the document
 Human readability - human readable
Source: HL7 CDA R2
64
A Clinical Document (3)
• A CDA document is a defined & complete
information object that can include
 Text
 Images
 Sounds
 Other multimedia content
Source: HL7 CDA R2
65
CDA Releases
• CDA Release 1 (ANSI-approved in 2000)
– First specification derived from HL7 RIM
• CDA Release 2 (2005) - Current Release
– Basic model essentially unchanged from R1
• Document has a header & a body
• Body contains nested sections
• Sections can be coded using standard vocabularies and can
contain entries
– Derived from HL7 RIM Version 2.07
Source: HL7 CDA R2
66
Key Aspects of CDA
• CDA documents are encoded in XML
 When alternative implementations are feasible,
new conformance requirements will be issued
• CDA documents derive their machine
processable meaning from HL7 RIM and
use HL7 V3 Data Types
• CDA specification is richly expressive &
flexible
 Templates can be used to constrain generic
CDA specifications
Source: HL7 CDA R2
67
Scope of CDA
• Standardization of clinical documents for
exchange
• Data format of clinical documents outside
of exchange context (such as data format
used to store clinical documents) is
out-of-scope
Source: HL7 CDA R2
68
Scope of CDA
• CDA doesn’t specify creation or
management of documents and messages
related to document management
• Instead, HL7 V3 Structured Documents
WG provides specifications on standards
for document exchange within HL7 V3
messages (where CDA clinical documents
can become contents of the messages)
Source: HL7 CDA R2
69
Scope of CDA
Lab Technician Physician
Lab Report
Create
document
Process &
Store
document
Transmit
document
CDA
70
Scope of document content
• Clinical content of the documents is
defined by the RIM and not by CDA.
• CDA only standardizes the structure and
semantics required to exchange
documents.
Slide reproduced/adapted from Dr. Supachai Parchariyanon
71
Goals of CDA (1)
• Give priority to delivery of patient care
• Allow cost effective implementation across
as wide a spectrum of systems as possible
• Support exchange of human-readable
documents between users, including those
with different levels of technical
sophistication
• Promote longevity of all information
encoded according to this architecture
Source: HL7 CDA R2
72
Goals of CDA (2)
• Enable a wide range of post-exchange
processing applications
• Be compatible with a wide range of document
creation applications
• Promote exchange that is independent of the
underlying transfer or storage mechanism
• Prepare the design reasonably quickly
• Enable policy-makers to control their own
information requirements without extension to this
specification
Source: HL7 CDA R2
73
CDA & HL7 Messages
• Documents complement HL7 messaging
specifications
• Documents are defined and complete information
objects that can exist outside of a messaging
context
• A document can be a MIME-encoded payload
within an HL7 message
Source: “What is CDA R2? by Calvin E. Beebe
at HL7 Educational Summit in July 2012
74
CDA & Message Exchange
• CDA can be payload (or content) in any kind of
message
– HL7 V2.x message
– HL7 V3 message
– EDI ANSI X12 message
– IHE Cross-Enterprise Document Sharing (XDS)
message
• And it can be passed from one kind to
another
Source: “What is CDA R2? by Calvin E. Beebe
at HL7 Educational Summit in July 2012
75
CDA & Message Exchange
Clinical Document
(Payload)
HL7 V3 Message
(Message)
HL7 V2 Message
(Message)
Source: Adapted from “What is CDA R2? by Calvin E. Beebe
at HL7 Educational Summit in July 2012
76
CDA As Payload
Source: From “What is CDA R2? by Calvin E. Beebe
at HL7 Educational Summit in July 2012
77
MIME
• Multipurpose Internet Mail Extensions
• An Internet standard that extends the format of e-
mail to support
– Text in non-ASCII character sets
– Non-text attachments
– Message bodies with multiple parts
– Etc.
• Often used in e-mails & some HTTP data
• Encoding: e.g. base64 (converting bits into
64 ASCII characters
Source: http://en.wikipedia.org/wiki/MIME
78
Base64 Encoding
• TWFuIGlzIGRpc3Rpbmd1aXNoZWQsIG5vdCBvbmx5IGJ
5IGhpcyByZWFzb24sIGJ1dCBieSB0aGlzIHNpbmd1bG
FyIHBhc3Npb24gZnJvbSBvdGhlciBhbmltYWxzLCB3a
GljaCBpcyBhIGx1c3Qgb2YgdGhlIG1pbmQsIHRoYXQg
YnkgYSBwZXJzZXZlcmFuY2Ugb2YgZGVsaWdodCBpbiB
0aGUgY29udGludWVkIGFuZCBpbmRlZmF0aWdhYmxlIG
dlbmVyYXRpb24gb2Yga25vd2xlZGdlLCBleGNlZWRzI
HRoZSBzaG9ydCB2ZWhlbWVuY2Ugb2YgYW55IGNhcm5h
bCBwbGVhc3VyZS4=
• Man is distinguished, not only by his reason, but by this singular
passion from other animals, which is a lust of the mind, that by a
perseverance of delight in the continued and indefatigable generation
of knowledge, exceeds the short vehemence of any carnal pleasure.
Source: http://en.wikipedia.org/wiki/Base64
79
Components of CDA Document
• Header
– Metadata requires for document discovery,
management, retrieval
• Body
– Section
– Entry (machine processable part)
– Narrative Block (human readable part)
Source: HL7 CDA R2
80
Major Components of a CDA
• A CDA document is wrapped by the
<ClinicalDocument> element, and contains a
header and a body.
• The header lies between the <ClinicalDocument>
and the <StructuredBody> elements and identifies
and classifies the document and provides
information on authentication, the encounter, the
patient, and the involved providers.
Slide reproduced/adapted from Dr. Supachai Parchariyanon
81
Major Components of a CDA
Slide reproduced/adapted from Dr. Supachai Parchariyanon
82
CDA Model
Source: From “What is CDA R2? by Calvin E. Beebe
at HL7 Educational Summit in July 2012
83
A Closer Look at a CDA Document
<ClinicalDocument> ... CDA Header ...
<structuredBody> <section> <text>... Single
Narrative Block ...</text>
<observation>...</observation>
<substanceAdministration>
<supply>...</supply>
</substanceAdministration> <observation>
<externalObservation>...
</externalObservation> </observation>
</section> <section> <section>...</section>
</section> </structuredBody>
</ClinicalDocument>
Source: HL7 CDA R2
Human Readable Part
Machine Processable Parts
84
Body –Structured Body
(Human Readable)
<section>
<caption>
<captionCode V="11496-7" S=“LOINC"/>
Allergies and Adverse Reactions
</caption>
<list>
<item><content ID=“A1”>Penicillin - Hives</content></item>
<item><content>Aspirin - Wheezing</content></item>
<item>
<content>Codeine – Itching and nausea</content>
</item>
</list>
<coded_entry>
<coded_entry.value ORIGTXT=“A1” V="DF-10074" S=“SNOMED“ DN=“Allergy to Penicillin”/>
</coded_entry>
</section>
NarrativeComputable
REQUIRED
Slide reproduced/adapted from Dr. Supachai Parchariyanon
85
Body - Structured Body
(Machine Processable)
<text>
<list>
<item><content ID="A1">Penicillin – Hives …
</list>
</text>
<entry>
<observation classCode="OBS" moodCode="EVN">
<code code="84100007" codeSystem="2.16.840.1.113883.6.96“
codeSystemName="SNOMED CT" displayName="History taking"/>
<value xsi:type="CD" code="247472004"
codeSystem="2.16.840.1.113883.6.96" displayName="Hives">
<originalText><reference value="#A1"/></originalText>
</value>
<entryRelationship typeCode="MFST">
<observation classCode="OBS" moodCode="EVN">
<code code="84100007" codeSystem="2.16.840.1.113883.6.96"
displayName="History taking"/>
<value xsi:type="CD" code="91936005“ CodeSystem="2.16.84…"
displayName=“PCN Allergy"/>
NarrativeComputable
OPTIONAL
Slide reproduced/adapted from Dr. Supachai Parchariyanon
86
Rendering CDA Documents (1)
Source: From “What is CDA R2? by Calvin E. Beebe
at HL7 Educational Summit in July 2012
87
Rendering CDA Documents (2)
Source: From “What is CDA R2? by Calvin E. Beebe
at HL7 Educational Summit in July 2012
88
Rendering CDA Documents (3)
• Different recipients may use different style sheets
to render the same CDA document, and thus may
display it differently (but the same content is
presented)
• This can help facilitate display of CDA documents
with specific preferences or local requirements
89
CDA & Document Management
• CDA focuses on document exchange, not
storage or processing
• Clinical documents are used for various reasons
– Clinical care
– Medico-legal reasons (as evidence)
– Auditing
– Etc.
• Clinical documents may contain errors or need
data updates (e.g. preliminary lab results vs. final
results)
90
Some Possible Use Cases of CDA
 Intra-institutional
 Exchange of parts of medical records (scanned or
structured electronic health records)
 Lab/Imaging requests & reports
 Prescriptions/order forms
 Admission notes
 Progress notes
 Operative notes
 Discharge summaries
 Payment receipts
 Other forms/documents (clinical or administrative)
91
Some Possible Use Cases of CDA
 Inter-institutional
 Referral letters
 Claims requests or reimbursement documents
 External lab/imaging reports
 Visit summary documents
 Insurance eligibility & coverage documents
 Identification documents
 Disease reporting
 Other administrative reports
92
Achieving Interoperability
 CDA is a general-purpose, broad standard
 Use in each use case or context requires
implementation guides to constrain CDA
 Examples
 Operative Note (OP)
 Consultation Notes (CON)
 Care Record Summary (CRS)
 Continuity of Care Document (CCD)
 CDA for Public Health Case Reports (PHCRPT)
 Quality Reporting Document Architecture (QRDA)
93
CDA Summary
 CDA is a markup standard for document
exchange
 Not message exchange
 Not document storage or processing
 CDA is a general-purpose standard
 Use in specific context requires
Implementation Guides (and possibly
Extensions)
94
CDA Summary
 CDA is XML-based and RIM-based
 CDA documents can be exchanged as
encapsulated data (payload) in any message
(HL7 V2, HL7 V3, etc.)
 CDA is not dependent on using HL7 V3
messages
 Most likely early use cases for CDA
 Referrals
 Claims & Reimbursements
 Lab/imaging Reports
 Electronic Health Records Documents
95
HL7: Take Home Message
• HL7 is not panacea and so does other standards
• People and processes matter most
• Do not aim to build HIS to comply with HL7
specification but do aim to let it be able to
communicate to another systems via HL7
• Most specifications in standards and
interoperability provide framework but not
implementation guide, at times you need experts
Slide reproduced/adapted from Dr. Supachai Parchariyanon
96
Additional Information
• Health Level Seven http://www.hl7.org
• HL7 Reference Information Model
– https://www.hl7.org/library/data-model/RIM/C30202/rim.htm
• HL7 Vocabulary Domains
– http://www.hl7.org/library/data-model/RIM/C30123/vocabulary.htm
• HL7 v3 Standard
– http://www.hl7.org/v3ballot/html/welcome/environment/index.htm
• HL7 v3:
– “Driving Interoperability & Transforming Healthcare Information
Management” by Charles Mead, MD, MSc.
– http://www.healthcare-informatics.com/webinars/05_20_04.htm
• FHIR: http://www.hl7.org/implement/standards/fhir/
Slide reproduced/adapted from Dr. Supachai Parchariyanon
97
Q/A
Slide reproduced/adapted from Dr. Supachai Parchariyanon

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Hl7 Standards (September 15, 2016)

  • 1. 1 HL7 Standards Nawanan Theera-Ampornpunt, M.D., Ph.D. Department of Community Medicine Faculty of Medicine Ramathibodi Hospital Certified HL7 CDA Specialist Some slides reproduced & adapted with permission from Dr. Supachai Parchariyanon September 15, 2016
  • 2. 2 »Profile: Dr. Supachai Parchariyanon is a medical doctor who’s passionate about information technology and turn himself to be informatician and serial entrepreneurs. He’s also earned Business Management degree from Ramkamhaeng university and Biomedical Informatics degree from the US. He led the team to certify both HL7 Reference Information Model (RIM) and Clinical Document Architecture (CDA). His interest is now on standards and interoperability, clinical informatics and project management. »Keep in touch »supachaimd@gmail.com »http://www.facebook.com/supachaiMD Supachai Parchariyanon @supachaiMD Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 3. 3 Nawanan Theera-Ampornpunt 2003 M.D. (Ramathibodi) 2009 M.S. in Health Informatics (U of MN) 2011 Ph.D. in Health Informatics (U of MN) 2012 Certified HL7 CDA Specialist Former Deputy Chief, Informatics Division Deputy Executive Director for Informatics, Chakri Naruebodindra Medical Institute Faculty of Medicine Ramathibodi Hospital nawanan.the@mahidol.ac.th http://groups.google.com/group/ThaiHealthIT Research interests: • EHRs & health IT applications in clinical settings • Health IT adoption • Health informatics education & workforce development
  • 4. 4 Outline • Introduction to Standards & Interoperability • What is Health Level Seven (HL7)? • What HL7 does? • HL7 Version 2 • HL7 Version 3 Messaging Standard • Reference Information Model (RIM) • Clinical Document Architecture (CDA) Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 6. 6 Standards: Why? • The Large N Problem N = 2, Interface = 1 # Interfaces = N(N-1)/2 N = 3, Interface = 3 N = 5, Interface = 10 N = 100, Interface = 4,950
  • 7. 7 Health Information Exchange (HIE) Hospital A Hospital B Clinic C Government Lab Patient at Home
  • 8. 8 Objectives • Interoperability • Inter-operable systems Ultimate Goals • Continuity of Care • Quality  Safety  Timeliness  Effectiveness  Equity  Patient-Centeredness  Efficiency Why Health Information Standards?
  • 10. 10 Various Kinds of Standards • Unique Identifiers • Standard Data Sets • Vocabularies & Terminologies • Exchange Standards – Message Exchange – Document Exchange • Functional Standards • Technical Standards: Data Communications, Encryption, Security
  • 11. 11 Functional Semantic Syntactic How Standards Support Interoperability Technical Standards (TCP/IP, encryption, security) Exchange Standards (HL7 V2, HL7 V3 Messaging, HL7 CDA, DICOM) Vocabularies, Terminologies, Coding Systems (ICD-10, ICD-9, CPT, SNOMED CT, LOINC) Information Models (HL7 V3 RIM, ASTM CCR, HL7 CCD) Standard Data Sets Functional Standards (HL7 EHR Functional Specifications) Some may be hybrid: e.g. HL7 V3, HL7 CCD Unique ID
  • 12. 12 What is HL7? • HL7 is an ANSI-accredited Standards Development Organization (SDO) operating in the healthcare arena. • It is a non-profit organization made up of volunteers – providers, customers, vendors, government, etc. Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 13. 13 What is HL7? (Cont.) • HL7 is an acronym for Health Level Seven – Seven represents the highest, or “application” level of the International Standards Organization (ISO) communications model for Open Systems Interconnection (OSI) networks. Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 14. 14 OSI Model Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 15. 15 What HL7 does? • HL7 focuses on the clinical and administrative data domains. • It defines data exchange standards for these domains called messages or messaging specifications (aka HL7 messages) – Messages are developed by technical committees and special interest groups in the HL7 organization. • HL7 organization defines 2 versions of the messaging standard: – HL7 v2.x (syntactic only) – HL7 v3.0 (semantic capability added) Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 16. 16 What HL7 does? Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 17. 17 HL7 Standards • HL7 V2.x – Defines electronic messages supporting hospital operations • HL7 V3 • HL7 Clinical Document Architecture (CDA) Releases 1 and 2 • HL7 Arden Syntax – Representation of medical knowledge • HL7 EHR & PHR Functional Specifications • Etc.
  • 18. 18 The Industry Standard HL7 Version 2 (HL7 V2) • Not “Plug and Play” - it provides 80 percent of the interface and a framework to negotiate the remaining 20 percent on an interface-by-interface basis • Historically built in an ad hoc way because no other standard existed at the time • Generally provides compatibility between 2.X versions • Messaging-based standard built upon pipe and hat encoding • In the U.S., V2 is what most people think of when people say “HL7″ Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 19. 19 HL7 version2 • HL7 V2 is still the most commonly used HL7 standard – Over 90% of US hospitals have implemented some version of 2.x HL7 messages • The HL7 V2 messaging standard is considered: – The workhorse of data exchange in healthcare – The most widely implemented standard for healthcare information in the world • HL7 V2.5 was approved as an ANSI standard in 2003 • HL7 is currently working on version 2.7 Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 20. 20 HL7 V2 Message • Composed of reusable segments, each identified by a 3-letter mnemonic • All messages must start with header segment MSH which includes sender, receiver, date- time, message identifier, message type, and trigger event • Segments used in a message are determined by message type Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 21. 21 Part of Sample HL7 V2 Message (Lab Result) OBX|1|NM|10839-9^TROPONIN-I^LN||5|ng/ml| 0-1.3|H||H|F|19980309…
  • 22. 22 HL7 Basic Transaction Model send HL7 ADT A01 msg receive HL7 ACK msg ADT system Lab system Receive A01, send ACK (external) admit event trigger event network Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 23. 23 Patient Admission Scenario, Inform Lab System • Trigger event is admission : A01 • Message type is: ADT • Messages composed of: – MSH (message header) – PID (patient identification) – PV1 (visit data) Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 24. 24 HL7 V2 Message • Messages composed of – Segments composed of • Fields composed of – Components • Delimiters – Field separator: | – Component separator: ^ – Repetition separator: ~ – Escape character: – Subcomponent: & – Segment terminator: <cr> Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 25. 25 Message Header Segment - MSH MSH|^~|&|SMS|OR2|TMR|SICU|201010191535|password|ADT^A01|MSG1632|P|2.7<cr> Sending Unit Receiving Unit Date Time Message type Trigger ID Sending Place Receiving Place Message Number version Delimiters production Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 26. 26 PID Segment – 1/3 PID|Z12345^5^M11||||PATIENT^JOSEPH^M^IV| Patient ID Check digit Method Last name First name Middle Initial Suffix Patient name Null fields Data field Field delimiter Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 27. 27 PID Segment – 2/3 MAIDEN|19610605|M||C|1492 OCEAN STREET^ Mother’s maiden name Gender Date of birth Race Street address Data component Component delimiter Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 28. 28 PID Segment – 3/3 DURHAM^NC^27705|DUR|(919)684-6421<cr> City State Zip Code County Telephone Segment terminator Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 30. 30 Summary Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 31. 31 Rules Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 32. 32 Problems with HL7 v2 • HL7 v2 cannot support all this! – Ad Hoc design methodology – Ambiguous – lacking definition – Complicated, esoteric encoding rules. – Artifacts left to retain backward compatibility – Too much optionality – Can’t specify conformance – No standard vocabulary Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 33. 33 What’s Different About V3? • Conceptual foundation – A single, common reference information model to be used across HL7 • Semantic foundation – Explicitly defined concept domains drawn from the best terminologies • Abstract design methodology – That is technology-neutral – Able to be used with whatever is the technology de jour • XML, UML, etc. • Maintain a repository – Database of the semantic content – Ensures a single source and enable development of support tooling Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 34. 34 How is V3 different than V2? • V3 is approaching “Plug and Play” • V2 uses pipe and hat messaging, while V3 uses the Reference Information Model(RIM) and XML for messaging • V3 is a brand new start – it is NOT backward compatible with V2 Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 35. 35 HL7 V3 Standards • A family of standards based on V3 information models and development methodology • Components – HL7 V3 Reference Information Model (RIM) – HL7 V3 Messaging – HL7 Development Framework (HDF)
  • 36. 36 How HL7 V3 Works • Message sent from sending application to receiving application • Mostly triggered by an event • Typical scenario portrayed in a storyboard • Message in XML with machine-processable elements conforming to messaging standard • Data elements in message conform to RIM • Not designed for human readability
  • 37. 37 V3 Messaging Standard • Based on an object information model, called the Reference Information Model, (RIM) – This model is “abstract,” that is, it is defined without regard to how it is represented in a message “on the wire” or in a “service architecture” method or in a “clinical document” – In fact, each of these representations can contain the same “instance” of information • Consequently, can be extended incrementally when new clinical information domains need to be added, in a way that doesn’t require changing what has already been created Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 38. 38 HL7 V3 Messaging • V3 provides messaging standards for – Patient administration – Medical records – Orders – Laboratory – Claims & Reimbursement – Care provision – Clinical genomics – Public Health – Etc.
  • 39. 39 Sample HL7 V3 Message (Patient Registration) <?xml version="1.0" encoding="UTF-8"?> <PRPA_IN101311UV02 xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ITSVersion="XML_1.0" xsi:schemaLocation="urn:hl7-org:v3 ../schemas/PRPA_IN101311UV02.xsd"> ... <name use="SYL" > <given>นวนรรน</given> <family>ธีระอัมพรพันธุ์</family> </name> <name use="ABC"> <given>Nawanan</given> <family>Theera-Ampornpunt</family> </name> <administrativeGenderCode code="M"/> ... </PRPA_IN101311UV02> Message source adapted from Ramathibodi HL7 Project by Supachai Parchariyanon, Kavin Asavanant, Sireerat Srisiriratanakul & Chaiwiwat Tongtaweechaikit
  • 40. 40 HL7 V3 Reference Information Model • Referral • Transportation • Supply • Procedure • Consent • Observation • Medication • Administrative act • Financial act • Organization • Place • Person • Living Subject • Material • Patient • Member • Healthcare facility • Practitioner • Practitioner assignment • Specimen • Location Entity 0..* 1 Role 1 0..* 1 0..* Act Relationship 1..* 10..* 1 Participation Act • Author • Reviewer • Verifier • Subject • Target • Tracker • Has component • Is supported by Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 41. 41 HL7 V3 Components and Process: RIM UML Instance Scenario  Classes are color coded:  Green = Entity, Yellow = Role, Blue = Participation, Red/Pink = Act, Purple = Infrastructure, Lilac = message controller. John Doe Patient Subject Entity Role Participation Act Dr. Smith HealthCare Provider Surgeon John Doe Patient Subject Has Pertinent InformationAct Relationship (Clinical Trial Act) Protocol ECOG 1112 XYZ Hospital HealthCare Facility Location (Procedure Act) Prostectomy Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 42. 42 Reference Information Model (RIM) Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 43. 43 Source: “What is CDA R2? by Calvin E. Beebe at HL7 Educational Summit in July 2012
  • 44. 44 The HL7 V3 Solution • Approaching “Plug and Play” - less of a “framework for negotiation” • Utilizes RIM for data model • Utilizes XML as transport method • HL7 V3 is not the next release of HL7 V2 - It is a paradigm shift Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 45. 45 The HL7 V3 Solution (Cont.) • HL7 V3 addresses the problems of HL7 V2 by: – Reducing HL7 V2 optionality – Including testable conformance rules • HL7 V3 is based on a formal development methodology: – Follows an Object Oriented (OO) approach – Uses Universal Modeling Language (UML) principles • Most importantly, HL7 V3 supports semantic interoperability Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 46. 46 Interoperability in HL7 V3 • The Four Pillars of Semantic Interoperability in HL7 V3 – A common Reference Information Model (RIM) which spans the entire patient care, administrative and financial healthcare universe – A well-defined and tool-supported process for deriving data exchange specifications ("messages") from the RIM – A formal and robust Data Type Specification upon which to ground the RIM – A formal methodology for binding concept-based terminologies (vocabulary) to RIM attributes Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 47. 47 HL7 Model Repository • Database holding the core of HL7 semantic specifications – RIM – Storyboards – Vocabulary domains – Interaction models – Message designs – Message constraints Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 48. 48Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 49. 49 Navigating the V3 Ballot Publication Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 50. 50 Navigating the V3 Ballot Publication • Domains: The Functional Content of the Publication – Universal Realm Domains • Administration Domains • Health and Clinical Practice Domains • Common Use Domains – US Realm domains • Medicaid Information Technology Architecture (MITA) – Other realm specific domains.. Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 51. 51 Domain Publication Structure Each Realm contains a collection of Domains. Domains are further divided into Topics • Domain • Topic Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 52. 52 V3 Messaging Concerns • Difficult to implement • No one understands V3 • Overhead too much – 1% of message is payload compared to V2 (delimiters) is about 90-95% • No one understands what implementation of V3 messaging means • Need stability, clarity, definition of V3 messaging Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 53. 53 The Future of HL7 • FHIR: Fast Healthcare Interoperability Resources – Pronounced “Fire” • FHIR defines a set of “Resources” that represent granular clinical concepts, which can be managed in isolation, or aggregated into complex documents • Resources are based on simple XML or JSON structures, with an http-based RESTful protocol http://wiki.hl7.org/index.php?title=FHIR
  • 54. 54 HL7 Clinical Document Architecture (CDA) Nawanan Theera-Ampornpunt, M.D., Ph.D. Department of Community Medicine Faculty of Medicine Ramathibodi Hospital Certified HL7 CDA Specialist Some slides reproduced & adapted with permission from Dr. Supachai Parchariyanon
  • 55. 55 Message Exchange • Goal: Specify format for exchange of data • Internal vs. external messages • Examples  HL7 V2  HL7 V3 Messaging  DICOM  NCPDP Document Exchange • Goal: Specify format for exchange of “documents” • Examples  HL7 V3 Clinical Document Architecture (CDA)  ASTM Continuity of Care Record (CCR)  HL7 Continuity of Care Document (CCD) Exchange Standards
  • 56. 56 Messages • Human Unreadable • Machine Processable Clinical Documents • Human Readable • (Ideally) Machine Processable Exchange Standards
  • 57. 57 Hospital A Hospital B Clinic C Government Lab Patient at Home Message Exchange Message Message Message Message Message
  • 58. 58 Hospital A Hospital B Clinic C Government Lab Patient at Home Clinical Document Exchange Message containing Referral Letter Message containing Claims Request Message containing Lab Report Message containing Patient Visit Summary Message containing Communicable Disease Report
  • 59. 59 What Is HL7 CDA? • “A document markup standard that specifies structure & semantics of “clinical documents” for the purpose of exchange” [Source: HL7 CDA Release 2] • Focuses on document exchange, not message exchange • A document is packaged in a message during exchange • Note: CDA is not designed for document storage. Only for exchange!!
  • 60. 60 What is CDA? • CDA is based on XML • XML is eXtensible Markup Language • In XML, structure & format are conveyed by markup which is embedded into the information Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 61. 61 Clinical Document Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 62. 62 A Clinical Document (1) • A documentation of clinical observations and services, with the following characteristics:  Persistence - continues to exist in an unaltered state, for a time period defined by local and regulatory requirements  Stewardship - maintained by an organization entrusted with its care  Potential for authentication - an assemblage of information that is intended to be legally authenticated Source: HL7 CDA R2
  • 63. 63 A Clinical Document (2) • A documentation of clinical observations and services, with the following characteristics:  Context - establishes the default context for its contents; can exist in non-messaging contexts  Wholeness - Authentication of a clinical document applies to the whole and does not apply to portions of the document without full context of the document  Human readability - human readable Source: HL7 CDA R2
  • 64. 64 A Clinical Document (3) • A CDA document is a defined & complete information object that can include  Text  Images  Sounds  Other multimedia content Source: HL7 CDA R2
  • 65. 65 CDA Releases • CDA Release 1 (ANSI-approved in 2000) – First specification derived from HL7 RIM • CDA Release 2 (2005) - Current Release – Basic model essentially unchanged from R1 • Document has a header & a body • Body contains nested sections • Sections can be coded using standard vocabularies and can contain entries – Derived from HL7 RIM Version 2.07 Source: HL7 CDA R2
  • 66. 66 Key Aspects of CDA • CDA documents are encoded in XML  When alternative implementations are feasible, new conformance requirements will be issued • CDA documents derive their machine processable meaning from HL7 RIM and use HL7 V3 Data Types • CDA specification is richly expressive & flexible  Templates can be used to constrain generic CDA specifications Source: HL7 CDA R2
  • 67. 67 Scope of CDA • Standardization of clinical documents for exchange • Data format of clinical documents outside of exchange context (such as data format used to store clinical documents) is out-of-scope Source: HL7 CDA R2
  • 68. 68 Scope of CDA • CDA doesn’t specify creation or management of documents and messages related to document management • Instead, HL7 V3 Structured Documents WG provides specifications on standards for document exchange within HL7 V3 messages (where CDA clinical documents can become contents of the messages) Source: HL7 CDA R2
  • 69. 69 Scope of CDA Lab Technician Physician Lab Report Create document Process & Store document Transmit document CDA
  • 70. 70 Scope of document content • Clinical content of the documents is defined by the RIM and not by CDA. • CDA only standardizes the structure and semantics required to exchange documents. Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 71. 71 Goals of CDA (1) • Give priority to delivery of patient care • Allow cost effective implementation across as wide a spectrum of systems as possible • Support exchange of human-readable documents between users, including those with different levels of technical sophistication • Promote longevity of all information encoded according to this architecture Source: HL7 CDA R2
  • 72. 72 Goals of CDA (2) • Enable a wide range of post-exchange processing applications • Be compatible with a wide range of document creation applications • Promote exchange that is independent of the underlying transfer or storage mechanism • Prepare the design reasonably quickly • Enable policy-makers to control their own information requirements without extension to this specification Source: HL7 CDA R2
  • 73. 73 CDA & HL7 Messages • Documents complement HL7 messaging specifications • Documents are defined and complete information objects that can exist outside of a messaging context • A document can be a MIME-encoded payload within an HL7 message Source: “What is CDA R2? by Calvin E. Beebe at HL7 Educational Summit in July 2012
  • 74. 74 CDA & Message Exchange • CDA can be payload (or content) in any kind of message – HL7 V2.x message – HL7 V3 message – EDI ANSI X12 message – IHE Cross-Enterprise Document Sharing (XDS) message • And it can be passed from one kind to another Source: “What is CDA R2? by Calvin E. Beebe at HL7 Educational Summit in July 2012
  • 75. 75 CDA & Message Exchange Clinical Document (Payload) HL7 V3 Message (Message) HL7 V2 Message (Message) Source: Adapted from “What is CDA R2? by Calvin E. Beebe at HL7 Educational Summit in July 2012
  • 76. 76 CDA As Payload Source: From “What is CDA R2? by Calvin E. Beebe at HL7 Educational Summit in July 2012
  • 77. 77 MIME • Multipurpose Internet Mail Extensions • An Internet standard that extends the format of e- mail to support – Text in non-ASCII character sets – Non-text attachments – Message bodies with multiple parts – Etc. • Often used in e-mails & some HTTP data • Encoding: e.g. base64 (converting bits into 64 ASCII characters Source: http://en.wikipedia.org/wiki/MIME
  • 78. 78 Base64 Encoding • TWFuIGlzIGRpc3Rpbmd1aXNoZWQsIG5vdCBvbmx5IGJ 5IGhpcyByZWFzb24sIGJ1dCBieSB0aGlzIHNpbmd1bG FyIHBhc3Npb24gZnJvbSBvdGhlciBhbmltYWxzLCB3a GljaCBpcyBhIGx1c3Qgb2YgdGhlIG1pbmQsIHRoYXQg YnkgYSBwZXJzZXZlcmFuY2Ugb2YgZGVsaWdodCBpbiB 0aGUgY29udGludWVkIGFuZCBpbmRlZmF0aWdhYmxlIG dlbmVyYXRpb24gb2Yga25vd2xlZGdlLCBleGNlZWRzI HRoZSBzaG9ydCB2ZWhlbWVuY2Ugb2YgYW55IGNhcm5h bCBwbGVhc3VyZS4= • Man is distinguished, not only by his reason, but by this singular passion from other animals, which is a lust of the mind, that by a perseverance of delight in the continued and indefatigable generation of knowledge, exceeds the short vehemence of any carnal pleasure. Source: http://en.wikipedia.org/wiki/Base64
  • 79. 79 Components of CDA Document • Header – Metadata requires for document discovery, management, retrieval • Body – Section – Entry (machine processable part) – Narrative Block (human readable part) Source: HL7 CDA R2
  • 80. 80 Major Components of a CDA • A CDA document is wrapped by the <ClinicalDocument> element, and contains a header and a body. • The header lies between the <ClinicalDocument> and the <StructuredBody> elements and identifies and classifies the document and provides information on authentication, the encounter, the patient, and the involved providers. Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 81. 81 Major Components of a CDA Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 82. 82 CDA Model Source: From “What is CDA R2? by Calvin E. Beebe at HL7 Educational Summit in July 2012
  • 83. 83 A Closer Look at a CDA Document <ClinicalDocument> ... CDA Header ... <structuredBody> <section> <text>... Single Narrative Block ...</text> <observation>...</observation> <substanceAdministration> <supply>...</supply> </substanceAdministration> <observation> <externalObservation>... </externalObservation> </observation> </section> <section> <section>...</section> </section> </structuredBody> </ClinicalDocument> Source: HL7 CDA R2 Human Readable Part Machine Processable Parts
  • 84. 84 Body –Structured Body (Human Readable) <section> <caption> <captionCode V="11496-7" S=“LOINC"/> Allergies and Adverse Reactions </caption> <list> <item><content ID=“A1”>Penicillin - Hives</content></item> <item><content>Aspirin - Wheezing</content></item> <item> <content>Codeine – Itching and nausea</content> </item> </list> <coded_entry> <coded_entry.value ORIGTXT=“A1” V="DF-10074" S=“SNOMED“ DN=“Allergy to Penicillin”/> </coded_entry> </section> NarrativeComputable REQUIRED Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 85. 85 Body - Structured Body (Machine Processable) <text> <list> <item><content ID="A1">Penicillin – Hives … </list> </text> <entry> <observation classCode="OBS" moodCode="EVN"> <code code="84100007" codeSystem="2.16.840.1.113883.6.96“ codeSystemName="SNOMED CT" displayName="History taking"/> <value xsi:type="CD" code="247472004" codeSystem="2.16.840.1.113883.6.96" displayName="Hives"> <originalText><reference value="#A1"/></originalText> </value> <entryRelationship typeCode="MFST"> <observation classCode="OBS" moodCode="EVN"> <code code="84100007" codeSystem="2.16.840.1.113883.6.96" displayName="History taking"/> <value xsi:type="CD" code="91936005“ CodeSystem="2.16.84…" displayName=“PCN Allergy"/> NarrativeComputable OPTIONAL Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 86. 86 Rendering CDA Documents (1) Source: From “What is CDA R2? by Calvin E. Beebe at HL7 Educational Summit in July 2012
  • 87. 87 Rendering CDA Documents (2) Source: From “What is CDA R2? by Calvin E. Beebe at HL7 Educational Summit in July 2012
  • 88. 88 Rendering CDA Documents (3) • Different recipients may use different style sheets to render the same CDA document, and thus may display it differently (but the same content is presented) • This can help facilitate display of CDA documents with specific preferences or local requirements
  • 89. 89 CDA & Document Management • CDA focuses on document exchange, not storage or processing • Clinical documents are used for various reasons – Clinical care – Medico-legal reasons (as evidence) – Auditing – Etc. • Clinical documents may contain errors or need data updates (e.g. preliminary lab results vs. final results)
  • 90. 90 Some Possible Use Cases of CDA  Intra-institutional  Exchange of parts of medical records (scanned or structured electronic health records)  Lab/Imaging requests & reports  Prescriptions/order forms  Admission notes  Progress notes  Operative notes  Discharge summaries  Payment receipts  Other forms/documents (clinical or administrative)
  • 91. 91 Some Possible Use Cases of CDA  Inter-institutional  Referral letters  Claims requests or reimbursement documents  External lab/imaging reports  Visit summary documents  Insurance eligibility & coverage documents  Identification documents  Disease reporting  Other administrative reports
  • 92. 92 Achieving Interoperability  CDA is a general-purpose, broad standard  Use in each use case or context requires implementation guides to constrain CDA  Examples  Operative Note (OP)  Consultation Notes (CON)  Care Record Summary (CRS)  Continuity of Care Document (CCD)  CDA for Public Health Case Reports (PHCRPT)  Quality Reporting Document Architecture (QRDA)
  • 93. 93 CDA Summary  CDA is a markup standard for document exchange  Not message exchange  Not document storage or processing  CDA is a general-purpose standard  Use in specific context requires Implementation Guides (and possibly Extensions)
  • 94. 94 CDA Summary  CDA is XML-based and RIM-based  CDA documents can be exchanged as encapsulated data (payload) in any message (HL7 V2, HL7 V3, etc.)  CDA is not dependent on using HL7 V3 messages  Most likely early use cases for CDA  Referrals  Claims & Reimbursements  Lab/imaging Reports  Electronic Health Records Documents
  • 95. 95 HL7: Take Home Message • HL7 is not panacea and so does other standards • People and processes matter most • Do not aim to build HIS to comply with HL7 specification but do aim to let it be able to communicate to another systems via HL7 • Most specifications in standards and interoperability provide framework but not implementation guide, at times you need experts Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 96. 96 Additional Information • Health Level Seven http://www.hl7.org • HL7 Reference Information Model – https://www.hl7.org/library/data-model/RIM/C30202/rim.htm • HL7 Vocabulary Domains – http://www.hl7.org/library/data-model/RIM/C30123/vocabulary.htm • HL7 v3 Standard – http://www.hl7.org/v3ballot/html/welcome/environment/index.htm • HL7 v3: – “Driving Interoperability & Transforming Healthcare Information Management” by Charles Mead, MD, MSc. – http://www.healthcare-informatics.com/webinars/05_20_04.htm • FHIR: http://www.hl7.org/implement/standards/fhir/ Slide reproduced/adapted from Dr. Supachai Parchariyanon
  • 97. 97 Q/A Slide reproduced/adapted from Dr. Supachai Parchariyanon