Hl7 Standards, Reference Information Model & Clinical Document Architecture

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HL7 Standards

Nawanan Theera-Ampornpunt, M.D., Ph.D.Department of Community Medicine

Faculty of Medicine Ramathibodi HospitalCertified HL7 CDA Specialist

Some slides reproduced & adapted with permission from Dr. Supachai Parchariyanon

October 11, 2014

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»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»[email protected]»http://www.facebook.com/supachaiMD

Some Slides Reproduced with Permission from Dr. Supachai Parchariyanon@supachaiMD

Slide reproduced/adapted from Dr. Supachai Parchariyanon

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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 SpecialistFormer Deputy Chief, Informatics DivisionDeputy Executive Director for Informatics, Chakri Naruebodindra Medical InstituteFaculty of Medicine Ramathibodi Hospital

[email protected]://groups.google.com/group/ThaiHealthIT

Research interests:• EHRs & health IT applications in clinical settings• Health IT adoption• Health informatics education & workforce development

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Thailand’s HL7Certified Specialists

Kevin Asavanant

HL7 V3 RIM (2009)

SupachaiParchariyanonHL7 CDA (2010)

NawananTheera-Ampornpunt

HL7 CDA (2012)

SireeratSrisiriratanakul

HL7 V3 RIM (2013)

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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)• Interoperability in HL7 version3• V3 Normative Publication• Clinical Document Architecture (CDA)

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Standards Are Everywhere

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Standards: Why?

• The Large N ProblemN = 2, Interface = 1

# Interfaces = N(N-1)/2

N = 3, Interface = 3

N = 5, Interface = 10

N = 100, Interface = 4,950

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Health Information Exchange (HIE)

Hospital A Hospital B

Clinic C

Government

Lab Patient at Home

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Objectives• Interoperability• Inter-operable

systems

Ultimate Goals• Continuity of Care• Quality Safety Timeliness Effectiveness Equity Patient-Centeredness

Efficiency

Why Health Information Standards?

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What is interoperability?

It is the ability of two or more systems or components to exchange information, and to use the information that has been exchanged predictably (IEEE Standard Computer Dictionary)


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Levels of Interoperability

Functional

Semantic

Syntactic

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Goal of interoperability• HL7’s key goal of interoperability has

two aspects:– Syntactic interoperability has to do with

structure– Semantic interoperability has to do with

meaning


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Things that can go wrong in message exchange


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Standards are not equal Interoperability

Standards only create the opportunity for interoperability and are not equal to interoperability


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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

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Functional

Semantic

Syntactic

How Standards Support Interoperability

Technical Standards (TCP/IP, encryption,

security)

Exchange Standards (HL7 v.2, HL7 v.3 Messaging, HL7 CDA,

DICOM)

Vocabularies, Terminologies, Coding Systems (ICD-10, ICD-9,

CPT, SNOMED CT, LOINC)

Information Models (HL7 v.3 RIM, ASTM CCR, HL7 CCD)

Standard Data Sets

Functional Standards (HL7 EHRFunctional Specifications)

Some may be hybrid: e.g. HL7 v.3, HL7 CCD

Unique ID

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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.


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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.


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OSI Model


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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)


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What HL7 does?


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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.

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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″


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HL7 version2

• HL7 v2 is still the most commonly used HL7standard– 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


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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


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Part of Sample HL7 v.2 Message (Lab Result)

OBX|1|NM|10839-9^TROPONIN-I^LN||5|ng/ml|0-1.3|H||H|F|19980309…


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HL7 Basic Transaction Model

sendHL7 ADT A01 msg

receive HL7 ACK msg

ADT system

Lab system

Receive A01,send ACK

(external) admitevent

trigger event

network


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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)


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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>


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Message Header Segment - MSH

MSH|^~|&|SMS|OR2|TMR|SICU|201010191535|password|ADTÂ01|MSG1632|P|2.7<cr>

Sending Unit

Receiving Unit Date

TimeMessage

typeTrigger

ID

Sending Place Receiving

Place

Message Number

version

Delimiters

production


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PID Segment – 1/3

PID|Z12345^5^M11||||PATIENT^JOSEPH^MÎV|

Patient ID

Check digit

Method

Last nameFirst name

Middle Initial

Suffix

Patient name

Null fieldsData field

Field delimiter


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PID Segment – 2/3

MAIDEN|19610605|M||C|1492 OCEAN STREET^

Mother’s maiden name

Gender

Date of birth RaceStreet

address

Data component Component delimiter


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PID Segment – 3/3

DURHAM^NC^27705|DUR|(919)684-6421<cr>

City

State

Zip Code

County

Telephone

Segment terminator


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PV1 Segment

PV1|1|1|N2200^2200|||OR^02|0846^WELBY^MARCUS^G||SUR<cr>

Patient locationAttending

ServiceSequence

number

Patient class


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OBR Segment

OBR|1|330769.0001.001^DMCRES|0000514215^RADIS1|77061Û/S PEVLIC^L||201010211145|||||||||||||0491909||||U999|M||||||^FIBROIDS, R/O|207484^CARROLL&BARBARA&A|||089657&BROWN&JOANNE<CR>

Placer order number

Filler order number

Universal service ID

Text order Local set

Requested date-time of

service

Reason for study

Principal results interpreter


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Typical Result Message -ORU

MSH|^~\&|||||19981105131523||ORU^R01<cr>PID|||100928782^9^M11||Smith^John^J<cr>OBR||||Z0063-0^^LN<cr>OBX||XCN|Z0063-0^^LN||2093467^Smits^J^<cr>OBX||Z0092-0^^LN||203BE0004Y^^X12PTX<cr>

Data field

Data component

segment


Again, this slide shows a typical order result message. In this case, the segments include the header, the patient identifier, the order request, and two result segments. The OBX segment is examined in detail in the next slide. The last OBX shows the hierarchical nature of the segment. The test ID data field is broken into the triplet of code (with check-digit), text name, and vocabulary source (LOINC).

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Summary


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Admit Discharge Transfer (ADT)

MSH Message Header Segment[

EVN Event type segmentPID Patient Identification segmentPV1 Patient Visit segment[PV2] Patient Visit – Additional Information[{OBX}] Observation/Result

]


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RULES


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ADT event typesADTÂ13 Cancel discharge/end visitADTÂ04 Register a patientADTÂ08 Update patient informationADTÂ01 Admit/visit notificationADTÂ02 Transfer a patientADTÂ03 Discharge/end visitADTÂ28 Add person informationADTÂ14 Pending admitADTÂ05 Pre-admit a patientADTÂ31 Update person informationADTÂ07 Change an inpatient to an outpatientADTÂ06 Change an outpatient to an inpatientADTÂ11 Cancel admit/visit notificationADTÂ10 Patient arriving – trackingADTÂ09 Patient departing - trackingADTÂ12 Cancel transferADTÂ15 Pending transferADTÂ16 Pending dischargeADTÂ17 Swap patients

ADTÂ18Merge patient information (for backward compatibility only)

ADTÂ20 Bed status updateADTÂ32 Cancel patient arriving - trackingADTÂ33 Cancel patient departing - trackingADTÂ27 Cancel pending admitADTÂ25 Cancel pending dischargeADTÂ26 Cancel pending transferADTÂ23 Delete a patient recordADTÂ29 Delete person information

ADTÂ21 Patient goes on a "leave of absence"ADTÂ22 Patient returns from a "leave of absence"ADTÂ24 Link patient information

ADTÂ35Merge patient information - account number only (for backward compatibility only)

ADTÂ36 Merge patient information - patient ID and account number

ADTÂ34Merge patient information - patient ID only (for backward compatibility only)

ADTÂ30 Merge person information (for backward compatibility only)ADTÂ48 Change alternate patient ID (for backward compatibility only)ADTÂ49 Change patient account numberADTÂ46 Change patient ID (for backward compatibility only)ADTÂ47 Change patient identifier listADTÂ37 Unlink patient informationADTÂ38 Cancel pre-admitADTÂ41 Merge account - patient account numberADTÂ40 Merge patient - patient identifier listADTÂ39 Merge person - patient ID (for backward compatibility only)ADTÂ42 Merge visit - visit numberADTÂ44 Move account information - patient account numberADTÂ43 Move patient information - patient identifier listADTÂ45 Move visit information - visit numberADTÂ51 Change alternate visit IDADTÂ50 Change visit numberADTÂ52 Cancel leave of absence for a patientADTÂ53 Cancel patient returns from a leave of absenceADTÂ55 Cancel change attending doctorADTÂ54 Change attending doctorADTÂ60 Update allergy informationADTÂ62 Cancel change consulting doctorADTÂ61 Change consulting doctor


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Example message (ORU)

MSH|^~\&|HCLAB||HIS||20110826000629||ORU^R01|HCL0004461303|P|2.3||||||8859<cr>PID|1||4552213||^นาย เสมอ ใจด|ี|196404090000|M<cr>OBR|1|15817060|110524242|250034^Prothrombin time|U|20110825214807|||||||| 20110825230321||008850^บดภีทัร วรฐติอินันต|์|OER101^ทั่วไป แผนกผูป้่วยฉุกเฉนิ อาคารฉุกเฉนิ ชัน้ 1||||20110826000629||||||OER101^ทั่วไป แผนกผูป้่วยฉุกเฉนิ อาคารฉุกเฉนิ ชัน้ 1|||\LIS\REPORT\2011\08\25\20110825_25110524242.htm<cr>NTE|1||\.br\*อืน่ๆ\.br\Specimen Clotted โทรแจง้ เวลา 23.52 น. คณุ วชิดุา รับสาย<cr>OBX|1|ST|250539^PT||*|sec|10.5 - 13.5|N|||C|||20110826000146|LAR0101^หน่วยโลหติวทิยา|002108^อนุชา สรอ้ยสําโรง<cr>OBX|2|ST|250540^% Activity||*|%|70.0 - 120.0|N|||C|||20110826000146|LAR0101^หน่วยโลหติวทิยา|002108^อนุชา สรอ้ยสําโรง<cr>OBX|3|ST|250541ÎNR||*||0.91 - 1.17|N|||C|||20110826000146|LAR0101^หน่วยโลหติวทิยา|002108^อนุชา สรอ้ยสําโรง<cr>


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Problems with HL7v2

• 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


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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


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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


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HL7 V3 Standards

• A family of standards based on V3information models and development methodology

• Components– HL7 V3 Reference Information Model (RIM)– HL7 V3 Messaging– HL7 Development Framework (HDF)

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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

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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


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Why Cross-Reference to the RIM?

• Domain analysis models support communication within a domain

• Communications between domains requires an abstract, domain-independent model such as the HL7 RIM

• Cross-reference tables build the mappings from the narrow world of the individual domain to the cross-domain interoperability supported by the HL7 RIM


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HL7 V3 Messaging

• V3 provides messaging standards for– Patient administration– Medical records– Orders– Laboratory– Claims & Reimbursement– Care provision– Clinical genomics– Public Health– Etc.

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Sample HL7 v.3 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>ธรีะอมัพรพนัธุ</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

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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

Entity0..*

1Role

1

0..*

1

0..*

ActRelationship

1..*

10..*

1Participation Act

• Author• Reviewer• Verifier• Subject• Target• Tracker

• Has component• Is supported by


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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. SmithHealthCare

Provider Surgeon


Has Pertinent InformationAct Relationship

(Clinical Trial Act)Protocol ECOG

1112

XYZ Hospital

HealthCareFacility Location

(Procedure Act)Prostectomy


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Reference Information Model (RIM)

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54Source: “What is CDA R2? by Calvin E. Beebe at HL7 Educational Summit in July 2012

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The HL7 v3 Solution

• Approaching “Plug and Play” - less of a “framework for negotiation”

• Utilizes RIM for data model• Utilizes XML as transport method• HL7v3 is not the next release of HL7v2 -

It is a paradigm shift


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The HL7 v3 Solution (Cont.)

• HL7v3 addresses the problems of HL7v2by:– Reducing HL7v2 optionality– Including testable conformance rules

• HL7v3 is based on a formal development methodology:– Follows an Object Oriented (OO) approach– Uses Universal Modeling Language (UML) principles

• Most importantly, HL7v3 supports semantic interoperability


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Interoperability in HL7 v3

• The Four Pillars of Semantic Interoperability in HL7v3– 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


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HL7 Development Framework

• Formal methodology for mapping any “local”, domain -specific system, such as a “laboratory system” in the v3Reference model.

• Basic concept is that any system can be mapped into a “neutral” and formal UML-based Domain Analysis Model (DAM) with the help of domain experts.

• The DAM can then be mapped into the equivalent v3-RIM model.

• Mapping is bi-directional and highlights any changes needed by either the local system or the RIM to create a semantically complete mapping.

• RIM Harmonization process supports a standard way to add new domain requirements to the RIM in a way that doesn’t invalidate the previously created models – a feature of object-oriented paradigms. 58

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Model-based Development

HL7 Framework HL7 Specification

RIMData typesData elementsVocabularyTemplatesClinical Statements

Core Structured

Content

V3 Messaging

CDA Specifications

GELLO

System Oriented Architecture


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HL7 Model Repository

• Database holding the core of HL7semantic specifications– RIM– Storyboards– Vocabulary domains– Interaction models– Message designs– Message constraints


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HL7 Version 3.0

• Use-case Model• Reference Information Model• Domain Information Model• Message Information Model• Message Object Diagram• Hierarchical Message Description• Common Message Element Type


62Slide reproduced/adapted from Dr. Supachai Parchariyanon

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Domain Document Elements


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Example: HL7 v3



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Navigating the V3 Ballot Publication


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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..


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Domain Publication Structure

Each Realm contains a collection of Domains. Domains are further divided into Topics

• Domain• Topic


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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 v3messaging means

• Need stability, clarity, definition of v3 messaging


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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

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Additional Information

• Health Level Seven – 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


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Assignment 1

1._______ messaging standard is easy to use and understand. It is based on an implicit information model.

1. HL7 v3.n2. DICOM v2.n3. XML v3.n4. HL7 v2.n

2.HL7 message are composed of reusable segments, each identified by a __ -letter mnemonic.

1. 22. 33. 44. 5


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Assignment 1

3. In the HL7 transaction model a(n) _____ occurs and activates the sending of a specific message type to one or more receivers. 1. Acknowledgement2. Interface3. Trigger event4. message

4.___________ is the exclusive international standards body for imaging standards.

1. XML2. NCPDP3. DICOM4. IEEE


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Assignment 1

5. ___________ creates standards for pharmacy services.1. X12N2. NCPDP3. DICOM4. IEEE

6. _________ is the standards developing organization that focuses primarily on device standards.

1. X12N2. NCPDP3. DICOM4. IEEE


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Assignment 1

7. ______ has developed standards for the exchange of purchase-order data, invoice data and other commonly used business documents.


8.________ based on an object information model, called the Reference Information Model, (RIM), Patient Records.

1. HL7 v32. DICOM v2.n3. XML v3.n4. HL7 v2.n


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Assignment 1: Key

1._______ messaging standard is easy to use and understand. It is based on an implicit information model.

1. HL7 v3.n2. DICOM v2.n3. XML v3.n4. HL7 v2.n

2.HL7 message are composed of reusable segments, each identified by a __ -letter mnemonic.

1. 22. 33. 44. 5


77

Assignment 1: Key

3. In the HL7 transaction model a(n) _____ occurs and activates the sending of a specific message type to one or more receivers. 1. Acknowledgement2. Interface3. Trigger event4. message

4.___________ is the exclusive international standards body for imaging standards.

1. XML2. NCPDP3. DICOM4. IEEE


78

Assignment 1: Key

5. ___________ creates standards for pharmacy services.1. X12N2. NCPDP3. DICOM4. IEEE

6. _________ is the standards developing organization that focuses primarily on device standards.



79

Assignment 1: Key

7. ______ has developed standards for the exchange of purchase-order data, invoice data and other commonly used business documents.


8.________ is based on an object information model, called the Reference Information Model, (RIM).

1. HL7 v32. DICOM v2.n3. XML v3.n4. HL7 v2.n


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Assignment 2“READING AN ADT MESSAGE” For the Message:

MSH|^~\&|ADT_HGG||LAB_HGG||20090827120759||ADTÂ01ÂDT_A01|ADT_HGG00234509|P|2.6||||AL<cr> EVN||20090827120759<cr>PID|1||60719^^^HGG_ID^MR||EVERYWOMAN ÊVE||19780113100000|F|||2222 HOME STREET ^^ ANN ARBOR^MI^48104ÛSA <cr>NK1|1|KID^KEN|SPO|2222 HOME STREET^^ ANN ARBOR^MI^48104ÛSA |555-555-2005 <cr>PV1|1|I|23^GHH ROOM 2341^2341|U|||1436^ ATTENDÂARON|1026^SENDER^SAM||MED||||9|A0||1026ÂDMITÂLAN||H0100240|||||||||||||||||||||||||20090827120759<cr>IN1|1|CPS|HGG| HC Hospital General Gold, INC. |5555 WASHTEOLD AVENUE^SUITE2333^ ANN ARBOR^MI^48104ÛSA||555-555- 3002||||||||||||||||||||||||||||||||||||||||||444-22-2222 <cr>


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Assignment 2ASSIGNMENT 2 - “READING AN ADT MESSAGE” For the Message:

1: What type of message is it, and what is it used for? Who sent the message and when? 2: Who is the patient’s insurance company? Where is the insurer located? 3: What is the patient ID? Which is the personal relationship that the next of kin/associated party has to the patient? What is her name? What is the phone number of her contact (next of kin)? 4: Which clinicians are involved? Which roles are they playing? How old is the patient? 5: What is the episode or visit number? What is the patient’s last name? 6: Should we answer this message? Which application is expected to receive it? Which is the subcomponent separator? 7: Who is the attending doctor? What is the patient location?


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Assignment 2: KeyASSIGNMENT 2 - “READING AN ADT MESSAGE” For the Message:

1: What type of message is it (ADTÂ01ÂDT_A01,), and what is it used for?(Admit Visit Notification) Who sent the message and when? (ADT_HGG) at 20090827, 120759

2: Who is the patient’s insurance company? Where is the insurer located? CPS, 5555 WASHTEOLD AVENUE^SUITE2333^ ANN ARBOR^MI^48104ÛSA

3: What is the patient ID? 60719 Which is the personal relationship that the next of kin/associated party has to the patient? SPO What is her name?KID^KEN What is the phone number of her contact (next of kin)? 555-555- 2005


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Assignment 2: Key

4: Which clinicians are involved? Which roles are they playing? How old is the patient? AARON-ATTENDING, ALAN-ADMIT, 31

5: What is the episode or visit number? 1436 (Segment 19) What is the patient’s last name? EVERYWOMAN

6: Should we answer this message? YES Which application is expected to receive it? LAB_HGG Which is the subcomponent separator? &

7: Who is the attending doctor? AARON-ATTENDING What is the patient location? GHH ROOM 2341


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HL7 Reference Information Model (RIM)




October 11, 2014

85

Outline

• Reference Information Model (RIM)– Overview– RIM Domains– Domain Related Classes– Backbone Classes– HL7 v3 Process & Artifacts Overview– Data Types


86

Reference Information Model

• The RIM is the cornerstone of HL7 v3messaging.

• The RIM is an UML Model class diagram.• The RIM:

– Is the fundamental model from which all v3 messages are derived

– Is a generic, abstract model that expresses the information content of all the areas of healthcare

– Forms a shared view of the healthcare domain, and is used across all HL7 messages independent of message structure


87

RIM - Domain Related Classes


88

RIM Backbone Classes

A physical thing, group of physical things or an organization capable of participating in Acts, while in a role.

A record of something that is being done, has been done, can be done, or is intended or requested to be done.

A competency of the Entity playing the Role as identified, defined, guaranteed, or acknowledged by the Entity that Scopes the Role.

An association between an Act and a Role with an Entity playing that Role. Each Entity (in a Role) involved in an Act in a certain way is linked to the act by one Participation-instance.


A connection between two roles expressing a dependency between those roles.

A directed association between a source act and a target act.

Role Link Act Relationship

0..n1

0..n 0..n

1

0..1

0..n

0..n 0..n0..n 0..n

0..1

Classes are color coded:– Green = Entity, Yellow = Role, Blue = Participation, Red/Pink = Act,

Purple = Infrastructure, Lilac = message controller.


89

RIM as an Abstract Model

• The RIM is comprised of six “back-bone” classes:– Act: which represents the actions that are executed

and must be documented as health care is managed and provided

– Participation: which expresses the context for an act in terms such as who performed it, for whom it was done, where it was done

– Entity: which represents the physical things and beings that are of interest to, and take part in health care


90

– Role: which establishes the roles that entities play as they participate in health care acts

– ActRelationship: which represents the binding of one act to another, such as the relationship between an order for an observation and the observation event as it occurs

– RoleLink: which represents relationships between individual roles

RIM as an Abstract Model


91

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.



Dr. SmithHealthCare

Provider Surgeon


Has Pertinent InformationAct Relationship

(Clinical Trial Act)Protocol ECOG

1112

XYZ Hospital

HealthCareFacility Location

(Procedure Act)Prostectomy


92

RIM Entity Classes


93

RIM Entity Classes

classCode : CSdeterminerCode : CSid : SET<II>code : CEquantity : SET<PQ>name : BAG<EN>desc : EDstatusCode : SET<CS>existenceTime : IVL<TS>telecom : BAG<TEL>riskCode : CEhandlingCode : CE

Entity• Entity:

– a person, animal, organization or thing– A collection of classes related to the Entity

class, its specializations and related qualifying classes. The classes represent health care stakeholders and other things of interest to health care.

• Entity has the following sub-classes:– Container– Device– LanguageCommunication– LivingSubject– ManufacturedMaterial– Material– NonPersonLivingSubject– Organization– Person– Place


94

RIM Entity Classes: How to Read


Entity• Entity:

• Class name : Entity• Attributes : classCode,

determinerCode, id, etc.• Data type : immediately follows the

attribute name• Specializaton : LivingSubject and

Place are specializations of Entity

In other words, we would treat LivingSubject as an Entity with additional attributes.


95

RIM Entity Classes : How to Read


Entity


96

RIM Entity Classes : How to Read


Entity


97

RIM Role Classes


98

RIM Role Classes• Roles:

– A responsibility or part played by an entity (e.g. Person in a role of patient, employee, etc.) –different faces of an Entity

– A collection of classes related to the Role class and its specializations. These classes focus on the roles participants may play in health care..

• Role has the following sub‐classes:– Access– Employee– LicensedEntity– Patient– Health Care Provider– Member

classCode : CSid : SET<II>code : CEnegationInd : BLaddr : BAG<AD>telecom : BAG<TEL>statusCode : SET<CS>effectiveTime : IVL<TS>certificateText : EDquantity : RTOpositionNumber : LIST<INT>

Role


99

RIM Participation and Act Classes


100

RIM Participation Class

• Participation: – An association between an Act and a

Role with an Entity playing that Role.

• Participation has the following sub-class:– ManagedParticipation

Participation

typeCode : CSfunctionCode : CDcontextControlCode : CSsequenceNumber : INTnegationInd : BLnoteText : EDtime : IVL<TS>modeCode : CEawarenessCode : CEsignatureCode : CEsignatureText : EDperformInd : BLsubstitutionConditionCode : CE


101

RIM Act Class• Act:

– A collection of classes including the Act class and its specializations. These relate to the actions and events that constitute health care services. A record of something that is being done, has been done, can be done, or is intended or requested to be done.

• Act has the following sub-classes:– Account– ControlAct– DeviceTask– DiagnosticImage– Diet– FinancialContract– FinancialTransaction– InvoiceElement

Act

classCode : CSmoodCode : CSid : SET<II>code : CDnegationInd : BLderivationExpr : STtext : EDtitle : STstatusCode : SET<CS>effectiveTime : GTSactivityTime : GTSavailabilityTime : TSpriorityCode : SET<CE>confidentialityCode : SET<CE>repeatNumber : IVL<INT>interruptibleInd : BLlevelCode : CEindependentInd : BLuncertaintyCode : CEreasonCode : SET<CE>languageCode : CE


102

RIM ActRelationship Class

• ActRelationship:– A directed association

between a source Act and a target Act. A point from a later instance to a earlier instance OR point from collector instance to component instance.

• ActRelationship has no sub-classes.

inboundRelationship

ActRelationship

typeCode : CSinversionInd : BLcontextControlCode : CScontextConductionInd : BLsequenceNumber : INTpriorityNumber : INTpauseQuantity : PQcheckpointCode : CSsplitCode : CSjoinCode : CSnegationInd : BLconjunctionCode : CSlocalVariableName : STseperatableInd : BL

Act

0..n

0..n

source

0..n

target1

outboundRelationship


103

HL7 v3 Process & Artifacts Overview

RIM DMIM RMIM

1..* 1..*

1..*HMDMT

1..*


104

Domain Message Information Model (DMIM)

• A DMIM is a refined subset of the RIM that includes a set of class clones, attributes and relationships that can be used to create messages for a particular domain (a particular area of interest in healthcare).

• This is the DMIM for the Patient Administration Domain


105

Refined Message Information Model (RMIM)

• The RMIM is a subset of a DMIM that is used to express the information content for a message or set of messages with annotations and refinements that are message specific.

• This is the RMIM for the PatientLivingSubject Event Activate


106

Hierarchical Message Definition (HMD)

• An HMD is a serialized version of the RMIM in a specific order.

• This is the HMD for the PatientLivingSubject Event Activate


107

Message Type (MT)

A Message specification is a set of rules for constructing a message given a specific set of instance data

This is the XML schema for the PatientLivingSubjectEvent Activate message


108

Data Types

• Symbol: TS• Name: Point in Time• Description: A quantity specifying a point

on the axis of natural time. A point in time is most often represented as a calendar expression.


109

Data Types

• Symbol: ANY• Name: DataValue• Description: Defines the basic properties of

every data value. This is an abstract type, meaning that no value can be just a data value without belonging to any concrete type. Every concrete type is a specialization of this general abstract DataValue type.


110

Data Types

• Symbol: BL• Name: Boolean• Description: The Boolean type stands for

the values of two-valued logic. A Boolean value can be either true or false, or, as any other value may be NULL.


111

Data Types

• Symbol: BN• Name: Boolean not NULL• Description: The Boolean type stands for

the values of two-valued logic. A Boolean value can be either true or false, but can not be NULL.


112

Data Types

• Symbol: ST• Name: Character String• Description: The character string data type

stands for text data, primarily intended for machine processing (e.g., sorting, querying, indexing, etc.) Used for names, symbols, and formal expressions.


113

Data Types

• Symbol: CS• Name: Coded Simple Value• Description: Coded data in its simplest

form, where only the code and display name is not predetermined. The code system and code system version is fixed by the context in which the CS value occurs.

CS is used for coded attributes that have a single HL7-defined value set.


114

Data Types

• Symbol: CE• Name: Coded With Equivalents• Description: Coded data that consists of a

coded value (CV) and, optionally, coded

value(s) from other coding systems that identify the same concept. Used when alternative codes ma exist.


115

Data Types

• Symbol: SC• Name: Character String with Code• Description: A Character String that

optionally may have a code attached. The text must always be present if a code is present. The code is often a local code.


116

Data Types• Symbol: II• Name: Instance Identifier• Description: An identifier that uniquely

identifies a thing or object. Examples are object identifier for HL7 RIM objects, medical record number, order id, service catalog item id, Vehicle Identification Number (VIN), etc. Instance identifiers are defined based on ISO object identifiers.


117

Data Types

• Symbol: SET• Name: Set• Description: A value that contains other

distinct values in no particular order.


118

Data Types

• Symbol: BAG• Name: Bag• Description: An unordered collection of

values, where each value can be contained more than once in the bag, i.e., {a,a,b,c}


119

Data Types

• Symbol: IVL• Name: Interval• Description: A set of consecutive values of

an ordered base data type.


120

Data Types

• Symbol: ED• Name: Encapsulated Data• Description: Allows the transmission of text

of pointer to a text (for instance an URL)


121

Q/A


122

HL7 Clinical Document Architecture (CDA)




October 11, 2014

123

Message Exchange

• Goal: Specify format for exchange of data

• Internal vs. external messages

• Examples HL7 v.2 HL7 v.3 Messaging DICOM NCPDP

Document Exchange

• Goal: Specify format for exchange of “documents”

• Examples HL7 v.3 Clinical Document

Architecture (CDA) ASTM Continuity of Care

Record (CCR) HL7 Continuity of Care

Document (CCD)

Exchange Standards

124

Messages

• Human Unreadable• Machine Processable

Clinical Documents

• Human Readable• (Ideally) Machine

Processable

Exchange Standards

125


Clinic C

Government

Lab Patient at Home

Message Exchange

Message

Message

Message

Message Message

126


Clinic C

Government

Lab Patient at Home

Clinical Document ExchangeMessage containing

Referral Letter

Message containing Claims Request

Message containing Lab Report

Message containing Patient Visit Summary

Message containing Communicable Disease Report

127

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!!

128

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


129

Clinical Documents



131

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

132


• 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

133


• A CDA document is a defined & complete information object that can include Text Images Sounds Other multimedia content

Source: HL7 CDA R2

134

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 specificationsSource: HL7 CDA R2

135

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

136

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 V3messages (where CDA clinical documents can become contents of the messages)

Source: HL7 CDA R2

137

Scope of CDA

Lab Technician Physician

Lab Report

Create document

Process & Store

document

Transmit document

CDA

138

Scope of document content

• Clinical content of the documents is defined by the RIM and not by CDA. CDAonly standardizes the structure and semantics required to exchange documents.


139

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

140

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

141

Design Principles of CDA (1)

• Must be compatible with XML & HL7 RIM• Must be compatible with representations of

clinical information arising from other HL7committees

• Technical barriers to use of CDA should be minimized

• Specifies representation of instances required for exchange

Source: HL7 CDA R2

142


• Should impose minimal constraints or requirements on document structure and content required for exchange

• Must be scalable to accommodate fine-grained markup such as highly structured text & coded data

• Document specifications based on CDA(“Implementation Guides”) should accommodate constraints & requirements as supplied by appropriate professional, commercial & regulatory agencies

Source: HL7 CDA R2

143


• Document specifications for document creation & processing, if intended for exchange, should map to this exchange architecture

• CDA documents must be human readable using widely-available & commonly-deployed XML-aware browsers & print drivers and a generic CDA style sheet written in a standard style sheet language

• Use open standards

Source: HL7 CDA R2

144

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

145

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

146

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

147

CDA As Payload

Source: From “What is CDA R2? by Calvin E. Beebe at HL7 Educational Summit in July 2012

148

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 charactersSource: http://en.wikipedia.org/wiki/MIME

149

Base64 Encoding

• TWFuIGlzIGRpc3Rpbmd1aXNoZWQsIG5vdCBvbmx5IGJ5IGhpcyByZWFzb24sIGJ1dCBieSB0aGlzIHNpbmd1bGFyIHBhc3Npb24gZnJvbSBvdGhlciBhbmltYWxzLCB3aGljaCBpcyBhIGx1c3Qgb2YgdGhlIG1pbmQsIHRoYXQgYnkgYSBwZXJzZXZlcmFuY2Ugb2YgZGVsaWdodCBpbiB0aGUgY29udGludWVkIGFuZCBpbmRlZmF0aWdhYmxlIGdlbmVyYXRpb24gb2Yga25vd2xlZGdlLCBleGNlZWRzIHRoZSBzaG9ydCB2ZWhlbWVuY2Ugb2YgYW55IGNhcm5hbCBwbGVhc3VyZS4=

• 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

150

Components of CDA Document

• CDA = Header + Body

• Header– Metadata requires for document discovery, management,

retrieval

• Body– Section– Entry (machine processable)– Narrative Block (human readable)

Source: HL7 CDA R2

151

XML Markup for CDA• XML tag is defined <tag>• Data is expressed as data element name• Data value is “value”• Each entry has a start tag <tag> and a

stop tag /<tag>– <code> code = “11488-4” </code>

• Entries may be nested.


152

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.


153

Major Components of a CDA


154

CDA Model


155

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

156

Rendering CDA Documents (1)


157



158


• 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

159

Human Readability & Rendering CDA Documents (1)

• Receiver of a CDA document can algorithmically display clinical content of the note on a standard Web browser

• Sender should not be required to transmit a special style sheet along with a CDA document

• Must be possible to render all CDA documents with a single style sheet and general-market display tools

• Human readability applies to authenticated content (but no need to render other machine processable parts)

Source: HL7 CDA R2

160


• When structured content is derived from narrative, there must be a mechanism to describe the process by which machine-processableportions were derived from a block of narrative (e.g. by author, by human coder, by natural language processing algorithm, by specific software)

• When narrative is derived from structured content, there must be a mechanism to identify the process by which narrative was generated from structured data

Source: HL7 CDA R2

161


Source: HL7 CDA R2

<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>

Text to be rendered

162

CDA 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 are machine-processible to

the extent that can be modeled in the RIM.• All levels validate against the generic CDA schema.

Additional validation can be provided by templates and constraints on the generic schema.


163

Release 1: defined Level One, Level Two only


164

Release 2: Levels One, Two, Three


165

Header

• Main CDA elements : Header


166

Body


167

Body• Preferred non-XML document types:

– text/rtf– text/html– text/plain– application/pdf– image/g3fax– image/gif– image/tiff– image/jpeg– image/png


168

Body – Narrative Text


169

Body – Narrative Text (Table)

Example

Result


170

Body – Narrative Text (List)Example

Result


171

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>

Nar

rativ

eC

ompu

tabl

e

REQUIRED


172

Body - Structured Body (Machine Processible)

<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"/>

Nar

rativ

eC

ompu

tabl

e

OPTIONAL


173

Entries

Structure Body– Machine Processible


174

Entries - observation


175

Entries - observation• Derived from the RIM Observation class, it is

used to represent coded and other observations

Elements: • code: classification of observation • value: observation – can be any data type, need

to set that using xsi:type • effectiveTime: observation date/time • moodCode: observation requested (RQO) or

produced (EVN)


176

Entries - observation (Example)


177

Document & Section Codes

• The CDA specification permits the use of document codes and section codes. Thus, it is possible to differentiate a "Consultation Note" from a "Discharge Summary" because the two will have distinct document codes in the document instance.


178

Rendering Tags

<section><text><content emphasis="bold">

This is rendered bold,<content emphasis="italics">

this is rendered bold and italicized,</content>

this is rendered bold.</content></text></section>


179

Rendering Tags<section>

<code code="10153-2" codeSystem="2.16.840.1.113883.6.1“codeSystemName="LOINC"/>

<title>Past Medical History</title><text>

There is a history of <content ID="a1">Asthma</content></text><entry>

<Observation> <code code="84100007

codeSystem="2.16.840.1.113883.6.96"codeSystemName="SNOMED CT"displayName="history taking (procedure)"/>

<value xsi:type="CD" code="195967001"codeSystem="2.16.840.1.113883.6.96"codeSystemName="SNOMED CT"displayName="Asthma">

<originalText><reference value="#a1"/>

</originalText></value>

</Observation></entry>

</section>Slide reproduced/adapted from Dr. Supachai Parchariyanon

180

XML Markup of CDA Documents

• CDA instances are valid against CDA Schema• May be subject to additional validation• No prohibition against multiple schema

languages (W3C, DTD, RELAXNG, etc.) as long as conforming instances are compatible

Source: HL7 CDA R2

181

Design Principles ofCDA Schema (1)

• Design of CDA Schema follows more general requirements for CDA

• Follow general V3 XML ITS• CDA Schema is syntactic and not an adequate

map between conforming instance and HL7 RIM (semantics)

• Semantic interoperability of CDA instances requires CDA Schema, R-MIM & HD and corresponding RIM

Source: HL7 CDA R2

182

Design Principles ofCDA Schema (2)

• Forward and backward compatibility• Tag names should be clear, human-

understandable and map directly to RIM• Vocabulary can be enumerated within CDA

Schema or in an external, referenced source.– A vocabulary that is too large or is subject to change

should be maintained externally and referenced in CDA Schema

• CDA Schema should adhere to requirements of document analysis in derivation of content model

Source: HL7 CDA R2

183

Security, Confidentiality & Data Integrity

• Application systems sending and receiving CDAdocuments are responsible for meeting all legal requirements for– Document authentication– Document confidentiality– Document retention

• Encryption & source/recipient authentication may be necessary but is not part of CDA specs

• Confidentiality status is available within CDA

Source: HL7 CDA R2

184

CDA Conformance (1)

• CDA document originator application is responsible for ensuring that generated CDAdocuments are fully conformant to this specification

• Document recipient is responsible for ensuring that received CDA documents are rendered in accordance to this specification

• No persistent storage requirements for CDAdocuments defined by CDA (out-of-scope)

Source: HL7 CDA R2

185

CDA Conformance (2)

Recipient Responsibilities• Assume default values where defined and the document

instance doesn’t contain a value• Be able to parse & interpret complete CDA header (but

may or may not render header at its discretion)• Parse & interpret CDA body sufficiently to be able to

render it (title & narrative block)• Not required to parse & interpret complete set of CDA

entries in body• Not required to validate CDA document against

referenced templates

Source: HL7 CDA R2

186

CDA Conformance (3)

Originator Responsibilities• Properly construct CDA Narrative Blocks

– Section label is conveyed in Section.title component (except when unlabeled)

– Narrative contents are placed in Section.text (even if also conveyed in machine-processable entries)

– Contents of Section.text field must follow rules of Section Narrative Block

• Not required to fully encode all narrative into CDA entries within CDA body

Source: HL7 CDA R2

187

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)

188

CDA & Document Management

• CDA supports appending and replacement of documents through use of Document ID, setID, versionNumber & parent document– Supports version control of documents– Both old (replaced) and new versions of documents

can be stored in and retrieved from document management systems depending on situation

– Addendum is possible through append– Addendum itself can also be replaced with same

version control mechanism– Document management system (not CDA) is

responsible for keeping track of most up-to-date documents

189

Document Management Examples


190

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

191

Changes Between CDA R1 & R2

• In CDA R2, both header & body are fully RIM-derived

• Much richer assortment of entries to use within CDA sections

• R2 enables clinical content to be formally expressed to the extent that it is modeled in RIM

• A number of other changes– Deprecated components (retained for backward compatibility)– Changes in some component structure or vocabularies

Source: HL7 CDA R2

192

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)

193

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

194

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)

195

CDA Extensibility

Locally-defined markup possible when local semantics have no corresponding representation in CDA specification

Additional XML elements & attributes that are not included in CDA Schema are permitted in local extensions

196

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)

197

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 V3messages

Most likely early use cases for CDA Referrals Claims & Reimbursements Lab/imaging Reports Electronic Health Records Documents

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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


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Assignment

Assignment: Using the outline for a CDA, create a section for reporting a height and a weight measurement.


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Assignment: KeyAssignment: Using the outline for a CDA, create a section for reporting a height and a weight measurement.

Solution: There are different ways of answering this question. The simplest answer is just to use text.

<physical examination><height> “68 inches” </height><weight> “175 pounds” </weight>

</physical examination>Other solutions: You could look up a LOINC code, separate value and units.


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Q/A
