Workshop 4: Telematik-Plattform für eine verzahnte Versorgung auf derBasis von Interoperabilitätsstandards – Ist das bIT4health-Projekt state-of-the-art?

Neuere Entwicklungen in HL7 Version 3 – Ist HL7 ein

Kommunikations- oder ein Architekturstandard?

Bernd BlobelFraunhofer-Institut für Integrierte Schaltungen, Erlangen

Leiter der Projektgruppe GesundheitstelematikLeiter der GMDS AG “Standards für Kommunikation und

Interoperabilität”Vorsitzender der HL7-Benutzergruppe in Deutschland

Future-Proof Architecture for Health Information Systems and

Health Networks

Architecture Definition

• An architecture of a system describes its components, their functions and relationships.

Challenges for Future-ProofEHR Systems

• Enabled to specify, present, and manage knowledge• Enabled to specify, offer, and manage services• Enabled to compose and to reuse components

according to the actual needs• Follow the shared care paradigm in the sense of

specialisation and distribution, communication and co-operation

• Systems have to be process controlled, component-based and semantically interoperable

System Requirements

• Openness• Scalability• Portability• Distribution at Internet level• Based on standards• Service-oriented interoperability• Appropriate security and privacy services

Model-driven approach

Architectural Paradigms forFuture-Proof Health Information Systems

• Distribution• Component-orientation (flexibility, scalability)• Separation of platform-independent and platform-specific

modelling • Separation of logical and technological views (portability)• Specification of reference and domain models at meta-level• Interoperability at service level (concepts, contexts,

knowledge)• Enterprise view driven design (user acceptance)• Multi-tier architecture (user acceptance, performance, etc.)• Appropriate multi-media GUI (illiteracy)• Common terminology and ontology (semantic interoperability)• Appropriate security and privacy services

Business Concepts

Relations Network

Basic Services/Functions

Basic Concepts

Ent

erpr

ise

Vie

w

Info

rmat

ion

Vie

w

Com

puta

tiona

l Vie

w

Eng

inee

ring

Vie

w

Tech

nolo

gy V

iewComponent

View

ComponentDecomposition(Granularity)

PIM PSMxxxxx

xxxxxx

xxx

ReferenceModel

DomainModels

<schema targetnamespabc.xyz.org>

<xxx xxx xx>ssss sssssss

</xxxx><xxx xxx xx>

ssss sssssss</xxxx>

</schema>

DB

cons

train

ts

expo

rts

transfers transferstransfers

transfers

imports

transferstransfers

Servlet

InstanceAppletGUI

Model RepositoryMDA

Expression means:Metamodel Metamodel profile Platform

specificMeta-metamodel

Available Models:HL7 Development Framework

Entity1 Entity2

Entity1 Entity2Act

Entity1 Entity2ActF. Role1 F. Role2

Entity1 S. Role1 F. Role1 Act

Entity

Class_CD : CSCD : CVDeterminer_CD : CSStatus_CD : CS

Role

Class_CD : CSCD : CVEffective_TMR : IVL<TS>

Participation

Type_CD : CSTMR : IVL<TS>Status_CD : CS

Act

Class_CD : CSCD : CDMood_CD : CSStatus_CD : CSActivity_Time : GTS

1

0..* 1

0..*

1

0..*

RIM Core Attribute Value Sets (nach Woody Beeler)

EntityClass Code

•• Living SubjectLiving Subject•• PersonPerson•• OrganizationOrganization•• MaterialMaterial•• PlacePlace•• ......

RoleClass Code

•• PatientPatient•• ProviderProvider•• EmployeeEmployee•• SpecimenSpecimen•• PractitionerPractitioner•• ......

ParticipationType Code

•• PerformerPerformer•• AuthorAuthor•• WitnessWitness•• SubjectSubject•• DestinationDestination•• ......

ActClassCode

•• ObservationObservation•• ProcedureProcedure•• SupplySupply•• MedicationMedication•• FinancialFinancial•• ......

1

0..*

plays

validates

HL7 Version 3 Components• MDF → HDF• RIM• Data Types• Publication DB• Vocabulary• Clinical Templates

• Story Boards• DIMs• RMIMs (walking

through the graph)• CMETs• HMDs• Application Roles• Conformance

Statements

Categories of Data Types

HL7 version 3 data types• Null• ANY all • BL Boolean• ST Character String• INT Integer Number• REAL Real Number• QTY Quantity• PQ Physical Quantity• II Instance Identifier• ED Encapsulated

Data

• CS Code Value• CE Coded Equivalent• CD Concept

Descriptor• EN Entity Name• PN Person Name• ONOrganization

Name• TEL Telecom

Address• AD Postal Address• TS Point in Time

HL7 version 3 data types• “compositions” of

data types– IVL interval– SET set– BAG bag– RTO ratio

• Denoted as– IVL<type>– Example

• Other examples– Interval TS

IVL<TS>– Interval PQ

IVL<PQ>– Ratio QTY

RTO<QTY,QTY>

Very special:• General Timing

Specification GTS

IVL<TS> Interval TS

HL7 Development Framework

HL7 DEVELOPMENT FRAMEWORK (HDF)

• Chapter 1: Project Initiation and Management • Chapter 2: Requirements Gathering and

Analysis• Chapter 3: Requirements Normalization and

Harmonization• Chapter 4: Specification Design and Packaging• Chapter 5: Specification Publication and

Balloting• Chapter 6: Specification Refinement and

Localization• Chapter 7: Specification Implementation and

Validation

HDF Objectives• Installation of an unified process for developing

specifications and their implementation für die Entwicklung von Spezifikationen und deren Implementierungen nach den HL7-Paradigma

• Harmonisierung mit globalen Standards und PAS, die einem analogen Ansatz folgen

• Harmonisierung mit der Unified ModelingLanguage (UML) der Object Management Group (OMG)

-visibilityuml:ModelElement

-historyItem-annotations-formalName-sortKey-businessName

hl7ModelElement

uml:Namespace

uml:Packageuml:Classifier

-headerhl7Package

artifactPackage

document

domainPackage

staticModel

ballotPackageprofilePackage

Hl7DatatypeDefinition

-abstractuml:GeneralizableElement

datatypeModel

uml:Relationship

uml:Dependency

-reasonderivedFrom

Split into separate stereotypes for each 'type'

uml:Feature

uml:behaviorFeature

uml:TemplateArgument

-propertyKinddatatypeProperty

id is not inherited by property

-externalIdhl7Namespace

-kind-defaultValue

uml:parameter

vocabularyModel

vocabularyDomain

-isMandatory-conformance

hl7Feature

-codingStrengthhl7CodedDatatype

Attribute

Associations to'vocabularyDomain'and 'vocabularyCode'

-minimumSupportedLengthHl7UsedDatatypeHow to handle

codes w ith nominLength?

HL7 vs. UML Architectural Components

Mapping of the MDF to UMLMDF Metamodel Package UML Metamodel Package

Model Identification and Scope Model Management

Use Case Model Use Cases

Information Model Core

Vocabulary Domain Model Datatype

Datatype Model Datatype

Design Information Model Core

Hierarchal Message Description Core

Application Roles Collaborations

Interactions Collaborations

LOINCLogical Observation Identifier

Names and Codes

after C. McDonaldG. Schadow

J. Suico

LOINC Objectives• To provide a universal identifier for

observations, so information about observations from different sources can be combined in one electronic medical record systems or research/ management database.

• To provide a universal ID for HL7 OBX field #3 (Observation ID)

Areas of Development

• Laboratory• Clinical• HIPAA Attachment

Clinical LOINC Objective (after C. McDonald)

Create universal observation identifiers (test codes) for use in data exchange standards that follow a name-value pair strategy (HL7, DICOM, ASTM, CEN, etc.).

Of course, if you want to use them as observation identifiers in your EMR, that is fine too!

• Vital Signs• Hemodynamic

measures• Fluid Intake/Output• Body Measurements• Emergency

Department• Respiratory Therapy• Document sections• Standard survey

instruments• Ophthalmology

measurements

Clinical LOINC Subject Areas (after C. McDonald)

• EKG (ECG)• Cardiac Ultrasound• Obstetrical Ultrasound• Discharge Summary• History & Physical• Pathology Findings• Colonoscopy/Endosc

opy• Radiology reports• Clinical Documents• Tumor Registry

NewNew!!

New!New!

New!New!

New!New!

NewNew!!

Important facts (after C. McDonald)

• In 1995 LOINC 1.0 contained 4000 Clinical/26000 Lab LOINC codes

• In 2001 LOINC contained 30,400 entries• LOINC list servers at www.hl7.org• Download files and tools from Regenstrief

Web Site– www.regenstrief.org/loinc

• RELMA – a tool for mapping local codes to LOINC

Formal LOINC Components# Content/Sub-identifier Examples

0 Numeric code 3257-31 Component

Component identifier GLUCOSEStrain test information (amount, 2H POST 100G GLUCOSE POApplication form, time)Additional adjustments/conditions PH ADJUSTED TO 7.4Special information to distinct between PAT (patient), DON (donator),specimen and patient FET (foetus), CONT (control)

2 Measurement, type of measured/ MCNC (mass concentration)observed characteristic SCNC (substance concentrationperiod

3 Time information about measured/ PT (point in time), 1H, 24H (hours)observed characteristic / observation 3D (days)period

4 System / investigation material SER (serum), PLAS (plasma)5 Scale type of measured/observed QN (quantitative), SQ (semi-quantitative)

characteristic QL (qualitative)6 Method used to achieve measured/ AGGL (agglutination), US (ultrasound)

observed characteristic EIA (enzyme-immuno-assay)

Numeric CodeScale

Method

Measurement

Compo

nent

System

LOINC Axes

Time

…SERPLASURSMNPATGENV…

PT1H24H…

QNORDORDQNNOMNAR

AGGLCFIBIFRIA…

SODIUMGLUCOSE^2 H POST 100 G GLUCOSE POGENTAMYCIN^TROUGHABO GROUPMICROORGANISM IDENTIFIED

MCNCSCNCVOLMCRTONCNC…

Example of a LOINC DB Record

Measurement

Component Time Scale type

13942-8 SPERMATOZOA.MOTILE : ACNC : PT : SMN : ORD : MICROSCOPY.LIGHT

NumericCode

MethodSystem/Investigationmaterial

Knowledge Representation

Constraint Languages

• OWL (Web Ontology Language)• OCL (Object Constraint Language)• XML/XML Schema• KIF (Knowledge Interchange Format)• GELLO• ADL

Arden Syntax

• Standard specification for defining and sharing modular health knowledge bases– Arden Syntax for Medical Logic Modules

(ASTM Standard)– Specification covers the sharing of

computerised health knowledge bases among personnel, information systems, and institutions

– Applicable to knowledge bases that can be represented as a set of discrete modules

Medical Logic Modules

• A MLM consists of three categories (maintenance, library, and knowledge)

• Each category consists of slots

Medical Logic Modules

• General layout

maintenance:slotname: slotbody;;slotname: slotbody;;

…library:

slotname: slotbody;;…knowledge:

slotname: slotbody;;…end:

Maintenance Category• title: Hepatits B Surface Antigen in Pregnant Woman;;• filename: hepatitis_B_in_pregnancy;;• version: 1.00;;• institution: Columbia Univerity;;• author: John M. Smith, Jr., M.D. (jms@cuasdf.bitnet);;• specialist:• date: 1989-01-01;;• validation: testing;;

Library Category• purpose: Screen for newborns who are at risk for

developing hepatitis B;;• explanation: This woman has a positive hepatitis B

surface antigen titer within the past year. Therefore her newborn is at risk for developing hepatitis B.;;

• Keywords: hepatitis B; pregnancy;;• Citations: 1. Steiner RW. Interpreting the fractional

excretion of sodium. Am J Med 1984;77:699-702.;;

• links:

Knowledge Category• type: data-driven;;• data: penicillin_storage:=event(store penicillin order);

penicillin_dose:=read last (dose of stored penicillin order);cephalosporin_storage:=event(store cephalosporin order);cephalosporin_dose:=read last(dose of stored cephalosporin order);;;

• priority: 50;;• evoke: (penicillin_storage WHERE penicillin_dose>500 OR

(cephalosporin_storage WHERE cephalosporin_dose>500);;• logic: IF penicillin_dose>500 OR cephalosporin_dose>500 THEN

…ENDIF;;

• action: (write, return, if-then, call statement)• urgency: 50;;

Parts of EN 13606Part 1: Reference Model

– comprehensive, generic EHR model drawing on 12 years of R&D and 2 previous CEN standards

– mapped to HL7 RIM and CDA

Part 2: Archetype Interchange Specification– adopting the openEHR archetype approach– compatible with HL7 Template specification

Part 3: Reference Archetypes and Term Lists– initial archetypes for Europe, and repository specification– micro-vocabularies for the Part 1 model

Part 4: Security– measures to support access control, consent and auditability of EHR

communications

Part 5: Exchange Models– messages and service interfaces to enable EHR and archetype communication

Questions?

Contact details:

Bernd Blobel Ph.D.Associate ProfessorHead of the Health Telematics GroupFraunhofer Institut Integrierte SchaltungenAm Wolfsmantel 3391058 ErlangenEmail: bbl@iis.fraunhofer.deTel.: +49-9131-776-5830Fax (Department Office): +49-9131-776-588