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IT-Standards and Standardization Approaches in Healthcare

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E-health basically comprises health services and information delivered or enhanced through the Internet and related technologies. The future healthcare system and its services, enabling e-health, are based on the communication between all information systems of all participants of an integrated treatment. Connecting the elements of each healthcare system (general practitioners, hospitals, health insurance companies, pharmacies, and so on) — even across national boarders — is an important issue for information systems research in healthcare. Current developments, such as upcoming or already-deployed electronic healthcare chip cards (that are to be used across Europe), show the need for Europe-wide standards and norms. In this article, we first outline the advantages of the standards, and then describe their main characteristics. After the introduction of communication standards, we present their comparison with the aim to support the different functions in the healthcare information systems. Subsequently, we describe the documentation standards, and discuss the goals of existing standardization approaches. Implications conclude the article.
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Encyclopedia
of Healthcare
Information Systems
Nilmini Wickramasinghe
Illinois Institute of Technology, USA
Eliezer Geisler
Illinois Institute of Technology, USA
Volume I
A-D
Hershey • New York
MEDICAL INFORMATION SCIENCE REFERENCE
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a claim of ownership by IGI Global of the trademark or registered trademark.
Library of Congress Cataloging-in-Publication Data
Encyclopedia of healthcare information systems / Nilmini Wickramasinghe and Eliezer Geisler, editors.
p. ; cm.
Includes bibliographical references.
Summary: “This book provides an extensive and rich compilation of international research, discussing the use, adoption, design, and diffusion of information
communication technologies (ICTs) in healthcare, including the role of ICTs in the future of healthcare delivery; access, quality, and value of healthcare;
nature and evaluation of medical technologies; ethics and social implications; and medical information management”--Provided by publisher.
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1. Medical informatics--Encyclopedias. I. Wickramasinghe, Nilmini. II. Geisler, Eliezer, 1942-
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813
I
IT-Standards and Standardization Approaches
in Healthcare
Ali Sunyaev
Technische Universitaet Muenchen, Germany
Jan Marco Leimeister
Technische Universitaet Muenchen, Germany
Andreas Schweiger
Technische Universitaet Muenchen, Germany
Helmut Krcmar
Technische Universitaet Muenchen, Germany
Copyright © 2008, IGI Global, distributing in print or electronic forms without written permission of IGI Global is prohibited.
INTRODUCTION
E-health basically comprises health services and in-
formation delivered or enhanced through the Internet
and related technologies (Eysenbach, 2001). The future
healthcare system and its services, enabling e-health, are
based on the communication between all information
systems of all participants of an integrated treatment.
Connecting the elements of each healthcare system
(general practitioners, hospitals, health insurance com-
panies, pharmacies, and so on)—even across national
boarders—is an important issue for information systems
research in healthcare. Current developments, such as
upcoming or already-deployed electronic healthcare
chip cards (that are to be used across Europe), show
the need for Europe-wide standards and norms (Sch-
weiger, Sunyaev, Leimeister, & Krcmar, 2007). In this
DUWLFOHZH¿UVWRXWOLQHWKHDGYDQWDJHVRIWKHVWDQGDUGV
and then describe their main characteristics. After the
introduction of communication standards, we present
their comparison with the aim to support the different
functions in the healthcare information systems. Sub-
sequently, we describe the documentation standards,
and discuss the goals of existing standardization ap-
proaches. Implications conclude the article.
BACKGROUND
The advantages of generally accepted standards for
the processes in healthcare and the medical market
can be summarized as follows (CEN/TC 251 European
Standardization of Health Informatics, http://www.
centc251.org/; Wirsz, 2000):
Standards increase competition and reduce
costs;
Standardized products could easily be replaced
or updated;
Standardized products of various suppliers could
easily exchange medical information;
Healthcare institutions are able to iteratively
extend their offers/capabilities;
Standardized products could reduce errors and
make healthcare services safer.
Several national and international committees,
German as well as European or American (CEN/TC
251 European Standardization of Health Informatics;
DIN, http://www.din.de; Integrating the Healthcare
Enterprise (IHE), http://www.ihe.net; Integrating the
Healthcare Enterprise-Europe (IHE-E), http://www.
ihe-eurpoe.org; World Health Organization (WHO),
http://www.who.int), have been founded to ensure
XQL¿HG VWDQGDUGL]DWLRQ RI QDWLRQDO DQG LQWHUQDWLRQDO
healthcare systems. Accordingly, there are numerous
standardization attempts, which partly correspond to,
but also disagree with, each other (Märkle & Lemke,
2002). Two main objectives of these committees can
be distinguished: the development of standards for
communication, and standards for documentation in
KHDOWKFDUH7KHIRUPHUIRFXVHVRQHQDEOLQJDQHI¿FLHQW
and effective combination of medical information sys-
tems, in order to enable the exchange of data between
814
IT-Standards and Standardization Approaches in Healthcare
different medical information systems (refer to IHE).
The latter are supposed to ensure the right interpretation
of the content of electronically exchanged information
(Haas, 2005).
IT-STANDARDS IN HEALTHCARE
The transmission of data between heterogeneous and
isolated medical information systems requires interop-
erability of systems and data (Hasselbring, 1997). The
interoperability on its side is composed of norms, inter-
faces, and standards—the basis for data exchange and
communication between participating applications (re-
fer to World Health Organization (WHO), http://www.
who.int). For an overview of common interoperability
standards in the healthcare sector, and the graphical
FODVVL¿FDWLRQRILWVUHODWLRQVVHH)LJXUH
Communication Standards
Communication standards, also called syntactical
standards, ensure a correct transmission of medical
and administrative data between different information
systems. In the clinical area, one can distinguish them
worldwide, mainly between the established standards
of Health Level 7/Clinical Document Architecture,
(HL7/CDA), Digital Imaging and Communications in
Medicine (DICOM), and Electronic Data Interchange
for Administration, Commerce and Transport (EDI-
FACT) (Pedersen & Hasselbring, 2004). The reason
for their acceptance is mainly the openness of these
standards.
Health Level 7 is an international, vendor-indepen-
dent, and main communication standard in healthcare
for the exchange of information between systems and
institutions. The Version 2 family of this standard is
based on events that trigger the exchange of data. Begin-
ning from Version 3 XML
1
, data structure is supported,
alleviating the integration of data into information
systems, since adequate libraries for XML handling are
available. HL7 operates at the application layer of the
ISO/OSI reference model (ISO7498-1, International
Organization of Standardization (ISO), 2006). The
Clinical Document Architecture (Health Level Seven
Inc., http://www.hl7.org/DPSOL¿HVWKH+/VWDQGDUG
with the description of the structure and the contents
of clinical documents (e.g., discharge summaries and
progress notes), based on an XML-format. HL7/CDA
also offers a model for the exchange or the common
use of information, and the option to individually re-
use this information (Dolin, Alschuler, Boyer, Beebe,
Behlen, & Biron, 2006).
Digital Imaging and Communications in Medi-
cine (National Electrical Manufacturers Association
(NEMA) , http://medical.nema.org) is an open standard
Figure 1. Medical communication and documentation standards
terminology system for medical terminology systems
medical terminology system
terminology system for communication standards
documentation standards
terminology system for documentation standards
communication standards
xDT EDIFACT
SNOMED
Contains
Metadata
for
Contains
Metadata
for
Contains
Metadata
For
< Is formulated via
< Is formulated via
1
1..*
1
1..*
1
0..*
1
1
1
1..*
1
1
LOINC CDA
DICOM HL7
MeSH UMLS ICD
Are
Communication
Standards
Are Documentation Standards
815
IT-Standards and Standardization Approaches in Healthcare
I
for the exchange of images in healthcare. Besides the
image, it can also contain additional meta-information,
such as the patient’s name, date of admission, device
parameters, or attending physician. The standard lists
WKHGDWD¿HOGVHJLPDJHVGLDJQRVLVSDWLHQWVVWXG-
ies, series, and so on), functions of network services,
as well as syntax and semantics for the commands and
messages. DICOM can store the images with or without
loss of information, in accordance to TIFF and JPEG
formats, and enables electronic archiving of images in
all medical information systems.
Electronic Data Interchange For Administration,
Commerce and Transport (EDIFACT, 2006) standard-
izes the formats for the electronic exchange of admin-
istrative data amongst others in healthcare information
systems. Orders, calculations, and payment orders in
the health service are often based on it. EDIFACT is,
unlike the other introduced communication standards,
QRWVSHFL¿FDOO\GHVLJQHGIRUWKHKHDOWKFDUH¿HOG²LWLV
used globally by business partners of different kinds of
business areas to exchange accounting-relevant data.
In the sector of general practitioners in Germany,
WKHUH DUH DGGLWLRQDOO\ VSHFL¿F VWDQGDUGV VR FDOOHG
xDT-standards (KBV, 2006). xDT is a set of several
German standards, which are supposed to simplify
the communication and the data exchange between
KHDOWKFDUHSURYLGHUVLHSK\VLFLDQ¶VRI¿FHVKRVSL-
tals, and so on) and health insurance companies. As a
result, xDT aims at the reduction of waste of paper by
applying information technology using the following
data formats:
ADT: AbrechnungsDatenTransfer (invoice data
for medical services)
AODT: AmbulantesOperierenDatenTransfer
(securing the quality of out-patient surgery)
BDT: BehandlungsDatenTransfer (for the com-
munication between general practitioners)
KVDT: KassenaerztlicheVereinigungDaten-
Transfer (standard for communication between
SK\VLFLDQ¶VRI¿FHVDQGKHDOWKLQVXUDQFHV
LDT: LaborDatenTransfer (communication with
laboratories)
GDT: GeraeteDatenTransfer (communication
with medical devices)
ODT: OnkologischerDatenTransfer (oncologi-
cal data carrier for the documentation of tumor
information)
Even though all of these xDT-standards serve dif-
ferent purposes, they are structured according to the
same basic rules and principles.
There are currently efforts to harmonize the intro-
duced communication standards on an XML-basis:
HL7/CDA incorporates already the XML-format for
structuring clinical documents; additionally, there are
DOVR;0/EDVHGVSHFL¿FDWLRQVIRUWKH',&20VWDQGDUG
(refer to NEMA), for the xDT-standards (Bundesmin-
isterium für Gesundheit und Soziale Sicherung, 2004),
and for EDIFACT (EDIFACT, 2006). The advantages
of introducing XML-based data structures can be de-
scribed as follows:
$XWRPDWLF SURFHVVLQJ FDQ EH VLPSOL¿HG ZKHQ
using established XML programming libraries.
XML is an open and platform-independent stan-
dard.
XML can be read and understood by users.
The introduced communication standards support
different functions in healthcare information systems
(Table 1: “x” connotes that the standard supports the
function, “-” connotes the opposite case). Such a use
of miscellaneous standards in several healthcare ser-
vice sectors is the most current problem in electronic
communication in medicine (Lenz, Beyer, Meiler,
Jablonski, & Kuhn, 2005).
Documentation Standards and
Standardization Approaches
For the right interpretation of the content of the elec-
tronically exchanged messages between different
medical information systems, there are terminology
and documentation standards, called semantic stan-
dards (see also Figure 1). The semantic standards are
responsible for the conversion of encoded medical
data, in order to, for example, correctly identify the
GLDJQRVLV/RJLFDO2EVHUYDWLRQ,GHQWL¿HUV1DPHVDQG
Codes (LOINC®, http://www.regenstrief.org/loinc) of-
fers a multidimensional terminology system for clinical
laboratories. It allows detailed descriptions of medical
circumstances for almost each clinical problem to be
solved automatically.
&ODVVL¿FDWLRQVDUHPHGLFDOV\VWHPVRIFRQFHSWVWKDW
are used for medical documentation. In comparison to
WHUPLQRORJ\V\VWHPVFODVVL¿FDWLRQVDUHOHVVFRPSOL-
cated, and thus mostly one-dimensional. “International
816
IT-Standards and Standardization Approaches in Healthcare
&ODVVL¿FDWLRQRI'LVHDVHV´,&'',0',KWWSZZZ
dimdi.de; refer also to WHO) is an example for such a
FODVVL¿FDWLRQRILOOQHVVHVDQGUHODWHGKHDOWKLVVXHV
Systemized Nomenclature of Medicine (SNOMED,
http://www.snomed.org/index.html) is a nomenclature.
Nomenclatures are combinations of terms that are based
on determined concept orders. SNOMED CT covers
WKHDUUDQJHPHQWRIDXQL¿HGWHUPLQRORJ\IRUH[SUHV-
VLRQVLQWKHPHGLFDO¿HOGDQGVXSSRUWVWKHODQJXDJHV
English, German and Spanish.
The thesaurus Medical Subject Headings (MeSH)
(United States National Library of Medicine, 2006) is
an extension of a nomenclature. MeSH mainly enables
indexing international publications—such as journals,
articles, and books—for the United States National
Library of Medicine (NLM). Enriching a thesaurus
with semantic and linguistic information yields a me-
WDWKHVDXUXV7KH³8QL¿HG0HGLFDO/DQJXDJH6\VWHP´
(UMLS, http://www.nlm.nih.gov/research/umls) is
a metathesaurus that tries to integrate all important
medical terms in only one term, and to represent all
possible term relations accordingly.
Because of the existence of different documentation
standards, a lot of incompatibilities occur, such as if
different users use different terminology systems for
the documentation (McDonald, 1997). The complete
LQWHURSHUDELOLW\ WKH FRQVHQW LGHQWL¿FDWLRQ FRQFHUQ-
ing the meaning of the medical data and meaningful
Functions in health care
DICOM xDT EDIFACT HL7/CDA
HIS x x x x
RIS x - - x
PACS x - - x
MPI (Master Patient
Index
)
-x - x
g
ra
p
hical dia
g
nosis x - - x
archivin
g
xx - x
dia
g
nosis comments - x - x
ima
g
e documentation x - - x
re
p
ort comments - - - x
video documentation - - - x
p
atient re
g
istration - x - x
ERP (Electronic Health
Records
)
xx x x
invoicin
g
-x x x
p
rescri
p
tions - - - x
data transformation - x - x
emer
g
enc
y
data - - - x
p
h
y
sician's
p
ractices - x x x
HIS - Hospital Information System,
PACS - Picture Archiving and Communication System,
RIS - Radiology Information System.
Medical communication standards
7DEOH&RPPXQLFDWLRQVWDQGDUGVDQGWKHLUIXQFWLRQV
817
IT-Standards and Standardization Approaches in Healthcare
I
Standardization approaches in healthcare Characterisation and Goal
Approach and assignment of interna-
tionally accepted standards
Integrating the healthcare enterprise (IHE)
(Hornung, Goetz, & Goldschmidt, 2005)
IHE is an international initiative, driven by health-
care professionals and industry, to improve the
communication of medical information systems and
the exchange of data.
IHE’s approach for the information inte-
gration is based on the propagation and
integration/usage of HL7 and DICOM
standards. IHE promotes and advances
these standards as a suggestion for
standardizing bodies.
Professionals and citizens network for
integrated care (PICNIC) (Danish Center for
Health Telematics, 2003)
PICNIC is a European project of regional healthcare
providers in a public-private partnership with
industry to develop new healthcare networks, and
to defragment the European market for healthcare
telematics.
The development is an open source
model, an open and interoperable archi-
tecture with exchangeable components
(aim is an easy and simple integration of
external products). All components must
be based on established standards, such
as HL7/CDA.
Distributed healthcare Environment (DHE,
http://www.gesi.it/dhe)
DHE has been created as a part of previous devel-
opment projects (e.g., HANSA-Project (http://www.
ehto.org/ht_projects/initial_project_
description/hansa.html)
for the integration of clinical information systems) to
build a platform to both integrate legacy healthcare
systems, and support the development of new ones.
DHE is an open middleware, which is
based on the “Healthcare Information
System Architecture” (HISE, CEN/TC
251 European Standardization of Health
Informatics) (Scherrer & Spahni, 1999).
DHE tries to specify generic healthcare
VHUYLFHVZKLFKDUHEDVHGRQSUHGH¿QHG
database-schemata, and offers them
on a common platform (e.g., with HL7-
interfaces).
Open electronic health record (The openEHR
foundation, http://www.openehr.org)
The openEHR foundation is dedicated to develop
DQRSHQVSHFL¿FDWLRQDQGLPSOHPHQWDWLRQIRUWKH
electronic health record (EHR). openEHR advances
the experiences of Good Eurpoean Health Record-
Projects (Blobel, 2006; GEHR, http://www.chime.
ucl.ac.uk/work-areas/ehrs/GEHR/) in England and
Australia.
The project works closely with standards
(e.g., HL7). However, it does not adopt
them verbatim, but tests, implements,
and improves their integration and
application, while giving feedback to the
standardizing bodies.
Standardization of communication between
LQIRUPDWLRQV\VWHPVLQSK\VLFLDQ¶VRI¿FHV
and hospitals using XML (Gerdsen, Müller,
Bader, Poljak, Jablonski, & Prokosch, (2005);
SCIPHOX, 2006)
SCIPHOX is a German initiative with the aim to
GH¿QHDQHZFRPPRQFRPPXQLFDWLRQVWDQGDUGIRU
ambulant and inpatient healthcare facilities.
The basis for the information exchange
is the XML-based HL7/CDA standard.
SCIPHOX adapts and improves this glo-
bal standard for local (German) needs.
www.akteonline.de (Schwarze, Tessmann,
Sassenberg, Müller, Prokosch, & Ückert,
2005; Ückert, Görz, Ataian, & Prokosch, 2002)
akteonline.de is German state-funded project to
develop a Web-based electronic healthcare record.
akteonline.de developed dynamic Web
pages, which can be accessed via
Internet, and look similar to physicians
and hospital software. The project is
based on the common communication
standards (DICOM and HL7/CDA).
$OOLQWURGXFHGLQLWLDWLYHVZLWKWKHH[FHSWLRQRI6&,3+2;GH¿QHGDQGGHYHORSHGDQ³(OHFWURQLF+HDOWKFDUH5HFRUG´(+&57DQJ$VK%DWHV
Overhage, & Sands, 2006)
7DEOH2YHUYLHZRIFXUUHQWVWDQGDUGL]DWLRQDSSURDFKHVLQKHDOWKFDUH
818
IT-Standards and Standardization Approaches in Healthcare
cooperation of functions, are the primary ones of
the main challenges for the near future of develop-
ment of healthcare information systems (Frist, 2005).
There are many different approaches to standardize
the electronic communication and documentation in
healthcare to achieve the interoperability. Some of the
promising standardization initiatives are summarized
in Table 2.
The analysis described in Table 2 shows that the
existing standardisation approaches for interoperability
in healthcare can be divided in two opposing groups
(Märkle & Lemke, 2002). On the one hand, there is
basically industry that propagates and adopts proprietary
standards like HL7 and DICOM. On the other hand,
there are generally university- and state-funded initia-
tives which use and support open standards as initiated
by European Committee of Standardization (CEN/TC
251 European Standardization of Health Informatics).
This difference is also based regionally—the former are
mainly located in the U.S., whereas the latter initiatives
come from Europe. For the future healthcare system, it
remains to be aspired that both camps learn from each
other and may grow together, and with it, the vision of
complete interoperability in the healthcare sector can
become true. Nevertheless, they all provided important
issues and contributed indispensable knowledge in at-
taining the present status.
IMPLICATIONS
Standards in healthcare are supposed to enable an ef-
¿FLHQWDQGHIIHFWLYHFRPPXQLFDWLRQRIGLVWULEXWHGDQG
isolated medical information systems. Unfortunately,
the current situation is not satisfying in terms of in-
teroperability. Until there is no generally accepted stan-
dardization for syntactic as well as semantic standards
in the healthcare sector, all advantages of standardized
solutions listed in the introduction cannot be exploited
(Haux, 2006). To improve health services and reduce
costs, the problem of interoperability (standardized
software solutions) has to be solved. Such interoper-
DEOH LQIRUPDWLRQ V\VWHPV FDQ LQÀXHQFH WKH TXDOLW\
of healthcare services and the adjunctive costs very
positively (Berger & Partner GmbH, 1997; Warda &
Noelle, 2002).
The issue of interoperability as major driver for
HI¿FLHQF\ LQ KHDOWKFDUH UHTXLUHV HIIRUWV DV WR KDU-
monization of standards, especially on the semantic
level. The existing and introduced communication
standards are able to deal with and connect different
medical information systems. But a great percentage
RIWKH SRWHQWLDOEHQH¿WV VWLOOUHPDLQXVHOHVVZLWKRXW
prior harmonisation of standards on a semantic level.
Future efforts from research and practice should focus
on this topic.
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3HUVSHNWLYHQGHUWHOHPHGL]LQLQ'HXWVFKODQG. Im Auf-
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Blobel, B. (2006). Advanced and secure architectural
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,QIRUPDWLFV
, 185–190.
Bundesministerium für Gesundheit und Soziale Siche-
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de/dynamic/de/ehealth/karte/downloadcenter/technik/
UDKPHQDUFKLWHNWXUWHOHPDWLNBUDKPHQDNWXHOOEKBVWDQ-
GDUGVBYSGI
Danish Center for Health Telematics. (2003). 3,&1,&
(professionals and citizens network for integrated care)
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6\VWHPV(33), 692-709.
Standardized Communication of Information Systems
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LQ'HXWVFKODQG0DWHULDOLHQXQGHPSIHKOXQJHQIUHLQH
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Wirsz, N. (2000). IT-standards im gesundheitswesen.
(OHFWURPHGLFD+HIW.
KEY TERMS
&ODVVL¿FDWLRQ Given representation of abstract
concepts, which are assigned to a set of categories.
Communication (Syntactic) Standards: Com-
munication standards ensure a correct transmission of
electronic data between different information systems,
in terms of a particular syntactical format.
Documentation (Semantic) Standards: Docu-
mentation standards ensure the right interpretation of
encoded medical data.
820
IT-Standards and Standardization Approaches in Healthcare
Interoperability: Denotes the ability of different,
independent, and heterogeneous information systems to
exchange electronic data for their further processing.
Metathesaurus: A thesaurus enriched with addi-
tional semantic and linguistic information.
Nomenclature: An accumulation of principles for
the consistent naming of objects.
Thesaurus: A given vocabulary with related
terms.
ENDNOTE
1
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(W3C), is used for the creation of machine- and
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of elements of structure and their arrangement
within the document tree.
XML is a subset of the Standard Generalized Mark-
up Language (SGML). It is also a metalanguage,
ZKLFKLVFDSDEOHRIGH¿QLQJQXPHURXVDPRXQWV
of different mark-up languages, which are still
closely related in their basic structure. In order to
describe the structure of XML documents, a so-
called “scheme language” is used. The two most
important scheme languages are the Document
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