Embed Size (px)
Citation preview
ISO 18308 Conformance StatementRev 1.5
Author: T Beale
Release 1
ISO 18308 Conformance Statement
Authors:T Beale1
Revision: 1.5.1
Pages: 51
1. Ocean Informatics Australia
Page 1 of 51 Date of Issue:09 Sep 2006
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
© 2002-2006 The openEHR Foundation
The openEHR foundationis an independent, non-profit community, facilitating the creation and sharing
of health records by consumers and clinicians via open-source, standards-based implementations.
email: [email protected] web: www.openEHR.org
Founding Chairman
David Ingram, Professor of Health Informatics, CHIME, University College London
Founding Mem-bers
Dr P Schloeffel, Dr S Heard, Dr D Kalra, D Lloyd, T Beale
ISO 18308 Conformance StatementRev 1.5
Copyright Notice
© Copyright openEHR Foundation 2001 - 2006All Rights Reserved
1. This document is protected by copyright and/or database right throughout the world and is owned by the openEHR Foundation.
2. You may read and print the document for private, non-commercial use. 3. You may use this document (in whole or in part) for the purposes of making
presentations and education, so long as such purposes are non-commercial and are designed to comment on, further the goals of, or inform third parties about, openEHR.
4. You must not alter, modify, add to or delete anything from the document you use (except as is permitted in paragraphs 2 and 3 above).
5. You shall, in any use of this document, include an acknowledgement in the form: "© Copyright openEHR Foundation 2001-2006. All rights reserved.
www.openEHR.org" 6. This document is being provided as a service to the academic community and on
a non-commercial basis. Accordingly, to the fullest extent permitted under applicable law, the openEHR Foundation accepts no liability and offers no warranties in relation to the materials and documentation and their content.
7. If you wish to commercialise, license, sell, distribute, use or otherwise copy the materials and documents on this site other than as provided for in paragraphs 1 to 6 above, you must comply with the terms and conditions of the openEHR Free Commercial Use Licence, or enter into a separate written agreement with openEHR Foundation covering such activities. The terms and conditions of the openEHR Free Commercial Use Licence can be found at http://www.openehr.org/free_commercial_use.htm
Date of Issue:09 Sep 2006 Page 2 of 51 Author: T Beale
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
ISO 18308 Conformance StatementRev 1.5
Amendment Record
AcknowledgementsThe work reported in this paper has been funded by a number of organisations, including The Univer-sity College, London; Ocean Informatics, Australia.
Issue Details Who Date
R E L E A S E 1.0.1
1.5.1 Updated to Release 1.0.1 reference model semantics. T Beale 09 Sep 2006
R E L E A S E 1.0
1.5 Updated to Release 1.0 reference model semantics. T Beale 02 Feb 2006
1.4 Updated to draft openEHR 0.9 Release for HealthConnect Aus-tralia. Changed title of document.
T Beale 20 Mar 2003
1.3 Updated to EHR RM 3.8.2 and Data Types RM 1.5.8; ISO Requirements TS V1.0
T Beale 10 Nov 2002
1.2 Updated to EHR RM 3.5 and Data Types RM 1.52 T Beale 19 Aug 2002
1.11 Minor adjustments. T Beale 5 Jul 2002
1.1 Updated to latest ISO requirements draft. T Beale,A Goodchild
28 Jun 2002
1.0 Initial Writing T Beale 20 Jun 2002
Author: T Beale Page 3 of 51 Date of Issue:09 Sep 2006
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
ISO 18308 Conformance StatementRev 1.5
Date of Issue:09 Sep 2006 Page 4 of 51 Author: T Beale
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
ISO 18308 Conformance StatementRev 1.5
Table of Contents
1 Introduction.............................................................................. 71.1 Purpose...................................................................................................71.2 Status......................................................................................................71.2.1 Versions............................................................................................71.2.2 Completeness...................................................................................71.3 Acronyms, Abbreviations and Definitions ............................................81.4 Methodology..........................................................................................81.5 Recommendations..................................................................................9
2 Mappings .................................................................................11ISO Section 1 Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11ISO Section 1.1 Record organisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11ISO Section 1.1.1 Sections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11ISO Section 1.1.2 EHR format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11ISO Section 1.1.3 Portability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12ISO Section 1.1.4 Secondary uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12ISO Section 1.1.5 Archiving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12ISO Section 1.2 Data Organisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12ISO Section 1.2.1 Structured Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13ISO Section 1.2.2 Non-structured data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13ISO Section 1.2.3 Clinical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15ISO Section 1.2.4 Administrative data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15ISO Section 1.3 Type and form of data. . . . . . . . . . . . . . . . . . . . . . . . . . . . 16ISO Section 1.3.1 Support for different types of data . . . . . . . . . . . . . . . . . . 17ISO Section 1.3.2 Data types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17ISO Section 1.3.3 Reference data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19ISO Section 1.3.4 Contextual Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19ISO Section 1.3.5 Links . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20ISO Section 1.4 Supporting health concept representation. . . . . . . . . . . . . 20ISO Section 1.4.1 Support for multiple coding systems . . . . . . . . . . . . . . . . 20ISO Section 1.4.2 Unique representation of information. . . . . . . . . . . . . . . . 21ISO Section 1.4.3 Language independence . . . . . . . . . . . . . . . . . . . . . . . . . . 21ISO Section 1.4.4 Representation of text . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21ISO Section 2 PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22ISO Section 2.1 Clinical processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22ISO Section 2.1.1 Support for clinical processes . . . . . . . . . . . . . . . . . . . . . . 22ISO Section 2.1.2 Problems/issues and health status . . . . . . . . . . . . . . . . . . . 23ISO Section 2.1.3 Clinical reasoning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23ISO Section 2.1.4 Decision support, guidelines, and protocols . . . . . . . . . . . 24ISO Section 2.1.5 Care Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25ISO Section 2.1.6 Orders & service processes. . . . . . . . . . . . . . . . . . . . . . . . 25ISO Section 2.1.7 Integrated care. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26ISO Section 2.1.8 Quality assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26ISO Section 2.2 Record processes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26ISO Section 2.2.1 Data capture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26ISO Section 2.2.2 Retrieval/query/views of data . . . . . . . . . . . . . . . . . . . . . . 27ISO Section 2.2.3 Presentation of data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Author: T Beale Page 5 of 51 Date of Issue:09 Sep 2006
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
ISO 18308 Conformance StatementRev 1.5
ISO Section 2.2.4 Scalability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28ISO Section 3 COMMUNICATION . . . . . . . . . . . . . . . . . . . . 29ISO Section 3.1 Messaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29ISO Section 3.2 Record exchange . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30ISO Section 4 PRIVACY AND SECURITY . . . . . . . . . . . . . 31ISO Section 4.1 Privacy and confidentiality. . . . . . . . . . . . . . . . . . . . . . . . 31ISO Section 4.2 Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31ISO Section 4.3 Access control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32ISO Section 4.4 Data integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32ISO Section 4.5 Auditability of access . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32ISO Section 5 MEDICO-LEGAL . . . . . . . . . . . . . . . . . . . . . . 34ISO Section 5.1 Support for legal requirements . . . . . . . . . . . . . . . . . . . . . 34ISO Section 5.2 Actors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34ISO Section 5.2.1 Subject of healthcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34ISO Section 5.2.2 Patient identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35ISO Section 5.2.3 User Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35ISO Section 5.2.4 Healthcare parties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35ISO Section 5.2.5 Author responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36ISO Section 5.2.6 Attestation/Authorization of entries . . . . . . . . . . . . . . . . . 36ISO Section 5.3 Clinical competence/governance . . . . . . . . . . . . . . . . . . . 37ISO Section 5.4 Faithfulness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37ISO Section 5.5 Preservation of context . . . . . . . . . . . . . . . . . . . . . . . . . . . 37ISO Section 5.6 Permanence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38ISO Section 5.7 Version control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38ISO Section 6 ETHICAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39ISO Section 6.1 Support for ethical justification . . . . . . . . . . . . . . . . . . . . 39ISO Section 7 CONSUMER/ CULTURAL . . . . . . . . . . . . . . 40ISO Section 7.1 Consumer issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40ISO Section 7.1.1 Support for consumer issues. . . . . . . . . . . . . . . . . . . . . . . 40ISO Section 7.2 Cultural issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41ISO Section 7.2.1 Support for cultural issues . . . . . . . . . . . . . . . . . . . . . . . . 41ISO Section 8 EVOLUTION . . . . . . . . . . . . . . . . . . . . . . . . . . 42ISO Section 8.1 Support for EHR architecture and EHR system evolution 42
3 Summary of Conformance Exceptions ................................ 454 ISO Requirements Requiring Review.................................. 47A References............................................................................... 49
Date of Issue:09 Sep 2006 Page 6 of 51 Author: T Beale
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
ISO 18308 Conformance Statement IntroductionRev 1.5
1 Introduction
1.1 PurposeThis document describes the compliance of the openEHR architecture to the draft ISO TC 215 Technical Spec-ification ISO/WD 18308, “Requirements for an Electronic Health Record Reference Architecture”. Theserequirements have been developed from numerous sources. Quoting from the 2002-06-28 draft:
An extensive search of the literature and direct contact with domain experts in many countrieshas been undertaken to identify as many existing sources of EHR requirements as possible.Material from over 35 primary sources has been obtained. This includes 20 sources originallycollected by the EHCR Support Action Project (EHCR-SupA) in Europe. This project wasestablished to support the work of CEN in developing a four part EHR communication stan-dard [CEN 13606, 1999) and one of its Deliverables [SupA1.4, 2000] was to provide "…a con-solidated classification of the requirements for the Electronic Health Care Record (EHCR) andEHCR architecture (EHCRA)." The 20 different primary EHR requirements documents used byEHCR-SupA came from many sources including relevant projects from the EU's Third andFourth Framework AIM programmes and from CEN. The 15 newly identified sources comefrom the United States, The Netherlands, Australia, and New Zealand.
As implied by the title, the ISO EHR requirements relate to EHR “reference architectures”, which include thearchitectures such as that published by openEHR. It is therefore appropriate to show how the openEHR archi-tecture satisfies or deviates from the the ISO requirements.
1.2 Status
1.2.1 VersionsThis document compares the ISO requirements draft document identified as ISO/WD 18308, published byISO TC 215 WG1, dated 2002-06-28 with the openEHR deliverables:
• openEHR EHR Reference Model (RM) revision 4.3 draft• openEHR EHR Demographic Reference Model revision 1.4.1 draft• openEHR EHR Common Reference Model revision 1.4.3• openEHR EHR Data Structures revision 1.3.1• openEHR EHR Data Types revision 1.7.2• openEHR archetype draft documents corresponding to these RM versions
In the future it is expected that this list will be expanded to include the following document:• openEHR consent/policy reference model
This document is available at http://svn.openehr.org/specification/TAGS/Release-1.0/publishing/requirements/iso81308_conformance.pdf.
The latest version of this document can be found at http://svn.openehr.org/specifica-tion/TRUNK/publishing/requirements/iso81308_conformance.pdf.
1.2.2 CompletenessIn the conformance column of the tables, the systems listed as having verified each feature in the architectureare not exhaustive, and undoubtedly do not include systems which have in fact verified the feature. These canbe added over time.
Author: T Beale Page 7 of 51 Date of Issue:09 Sep 2006
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
Introduction ISO 18308 Conformance StatementRev 1.5
1.3 Acronyms, Abbreviations and DefinitionsFor the most part, definitions of EHR-related concepts are to be found in ISO/WD 18308, which includes acomprehensive set of definitions. Abbreviations used in describing conformance are described below. A fewkey acronyms are repeated here for convenience.
EHR - Electronic Health Record. There is currently no single definition of “EHR” in ISO;EHRRA - EHR Reference Architecture, i.e. a formal model of EHR semantics as derived from a set of
requirements, and containing no design particularities, or features specific to any jurisdiction, styleof medicine, or culture;
RM - reference model; any formal model derived from requirements by analysis, but prior to theapplication of system design activities.
1.4 MethodologyThe approach taken in this document is to show for each ISO requirement what feature(s) of the openEHR ref-erence architecture satisfy the requirement.
The information is presented in a table of the form shown below. All ISO original content is shown in blue. AllISO numbering is preserved. Each requirement includes a number in parentheses denoting the heading numberin a heading framework developed by ISO WG1 for the purpose of classifying requirements. The numbers referto version 5.3 of the heading framework .
ConformanceConformance is described in two dimensions. The conformance of the openEHR models to the requirement isindicated by paragraphs like the following in the “conformance” column.Design: X
The following values of the letter ‘X’ are used:Full: Full conformance - the requirement is believed to be completely satisfied by the reference
architecture in a direct way, e.g. with a class or other feature specifically designed for the purpose;Qual: Qualified - the requirement is believed to be completely satisfied by the architecture;Part: Partial - the requirement is partially met by the current architecture;Fut: Future - the requirement will be met by a future revision of the architecture;No: No conformance - the requirement is not met by the architecture and is not intended to be satisfied in
the future;N/A: Not Applicable - In some cases, the current ISO requirement is not considered a valid requirement
for EHR reference architectures;Unk: Unknown - it is currently not known if the architecture caters for the requirement, or if it does it in
a manner desirable for implementation and information management.
Design conformance essentially indicates whether, in the openEHR design process, there has been consciousconsideration of the ISO requirement or one which is very similar or a superset, or use cases which are impliedby the ISO requirement.
However, the best intentions of design do not always guarantee success in implemented systems, due to factors
ISO Req’t Description openEHR artifact Conformance
IDN.N ISO description, verbatim from thecurrent ISO draft document. (ISOsource reference number)
Detail of how openEHR meets the require-ment
Level of conform-ance (see below).
Date of Issue:09 Sep 2006 Page 8 of 51 Author: T Beale
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
ISO 18308 Conformance Statement IntroductionRev 1.5
such as complexity, novelty (never before implemented), or difficulty of testing (e.g. requires large clinical tri-als). Hence, the second dimension indicates whether the openEHR reference architecture feature, or one like it(e.g. in one of the architectures on which openEHR is based, such as CEN 13606, GEHR or SynEx) has beenshown to work in practice. This is shown by “Validated” paragraphs like the following.Val: xxxx
The values here include the names of any of the following projects where a) the openEHR design feature waspresent and b) it was known to have fulfilled the ISO requirement.
CEN: Any CEN ENV 13606 implementationGEHR: The Australian Good Electronic Health Record project [9]. (It should be noted that the
Australian GEHR project (1997 - 2002) was heavily implementation oriented, while the originalGood European Health Record project (1992 - 1995) was a requirements-oriented project, and one ofthe precursors to the ISO 18308 technical specification described here);
HL7: ....OMG CorbaMed (HDTF): ...SNX: SynEx & Synapses European projects [4], [5]
The conformance assessments provide a guide to what elements of the openEHR architecture need to be ad-dressed in order to meet the ISO requirements. Non-conforming requirements are summarised in a hyperlinkedlist at the end of this document.
1.5 RecommendationsThree general rules of thumb should be respected by any requirement in a set of requirements, as follows:
• each statement expresses one requirement only;• it is clear how each statement would be tested, i.e. it would be easy to write a test case corresponding
to the requirement;• each statement expresses a requirement about the object of the requirements, not about something
else (usually related).
The current version of the ISO requirements does not always follows these rules. Some requirements (e.g. 3.9,3.15) actually express several requirements, and it is recommended that these be split out. Any requirementwhere multiple “design” entries are included in the conformance column.
Some requirements are unclear or vague, and the meaning is not obvious, nor is a way to state a test case. Finally,in a few cases, a few requirements are not considered to apply to an EHR reference architecture. In both casesmthese are indicated with a “TBR” (to be reviewed) paragraph of the following form:TBR 1: example TBR paragraph
These paragraphs may indicate the need for further review of the ISO requirement, either within ISO TC 215(in order to state the requirement more clearly, or correct it) or within openEHR, in order to better interpret therequirement. A hyperlinked summary list of TBR paragraphs is provided at the end of this document.
Author: T Beale Page 9 of 51 Date of Issue:09 Sep 2006
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
Introduction ISO 18308 Conformance StatementRev 1.5
Date of Issue:09 Sep 2006 Page 10 of 51 Author: T Beale
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
2M
appi
ngs
ISO
Sec
tion
1St
ruct
ure
ISO
Sec
tion
1.1
Rec
ord
orga
nisa
tion
ISO
Sec
tion
1.1.
1Se
ctio
ns
ISO
Sec
tion
1.1.
2EH
R fo
rmat
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
1.1
The
EHR
RA
mus
t en
able
inf
orm
atio
n in
the
EHR
to b
e or
gani
sed
in d
iffer
ent s
ectio
ns a
l-lo
win
g na
viga
tion
by u
sers
and
vie
ws
of s
ec-
tions
to
be r
etur
ned
as t
he r
esul
t of
que
ries.
(1.1
)
open
EHR
EH
R R
M:
COMPOSITIONs
pro
vide
coa
rse-
grai
ned
buck
ets. FOLDERs
refe
renc
e COMPOSI-
TIONs
, pro
vidi
ng c
ours
e-gr
aine
d vi
ews.
SECTIONs
pro
vide
nav
igat
iona
l he
adin
gs i
nsid
e COMPOSITIONs
. Q
uerie
s re
turn
PATH
s, w
hich
are
UR
I-st
yle
refe
renc
es.
Des
ign:
Ful
lVa
l: G
EHR
, C
EN
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
1.2
The
EHR
RA
mus
t ens
ure
that
the
'form
at' o
f the
EH
R a
s it
appe
ars t
o th
e cl
inic
ian
or u
ser i
s abl
e to
con
form
to sp
eci-
ficat
ions
set b
y st
anda
rds o
rgan
isat
ions
, reg
ulat
ory
and
ac-
cred
itatio
n ag
enci
es, p
rofe
ssio
nal g
roup
s, lo
cal h
ealth
care
inst
itutio
ns a
nd u
sers
. (1.
1)
open
EHR
EH
R R
M:
The
refe
renc
e m
odel
arc
hite
ctur
e pr
ovid
es g
ener
ic st
ruct
ures
whi
ch a
re
conf
igur
ed b
y do
mai
n-au
thor
ed a
rche
type
s, w
hich
can
be
devi
sed
to
refle
ct re
leva
nt st
anda
rds i
n st
ruct
urin
g.
Des
ign:
Ful
l
ISO
Sec
tion
1.1.
3Po
rtab
ility
ISO
Sec
tion
1.1.
4Se
cond
ary
uses
ISO
Sec
tion
1.1.
5A
rchi
ving
ISO
Sec
tion
1.2
Dat
a O
rgan
isat
ion
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
1.3
The
EHR
RA
mus
t sup
port
an E
HR
whi
ch is
mov
eabl
e an
dm
erge
able
bet
wee
n in
divi
dual
s and
inst
itutio
ns in
depe
nden
tof
har
dwar
e, so
ftwar
e (a
pplic
atio
n pr
ogra
ms,
oper
atin
g sy
s-te
ms,
prog
ram
min
g la
ngua
ges)
, dat
abas
es, n
etw
orks
, cod
ing
syst
ems,
and
natu
ral l
angu
ages
. (2.
6)
open
EHR
all
mod
els:
Mov
ing
and
mer
ging
sem
antic
s are
def
ined
by
the rm.com-
mon.change_control
pac
kage
and
the r
m.ehr_extract
pac
kage
. “V
irtua
l” v
ersi
on tr
ees a
re su
ppor
ted.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
1.4
The
EHR
RA
mus
t ena
ble
info
rmat
ion
in th
e EH
R to
be
orga
nise
dan
d re
triev
ed in
a m
anne
r tha
t fac
ilita
tes i
ts se
cond
ary
uses
. (1.
1)op
enEH
R E
HR
RM
:Pa
ths, FOLDERs
, COMPOSITIONs
, and
SECTIONs
all
prov
ide
mea
ns o
f ret
rievi
ng E
HR
dat
a in
arb
itrar
y w
ays.
The
mai
n qu
eryi
ng
pow
er is
due
to th
e us
e of
arc
hety
pe p
ath-
base
d qu
erie
s.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
1.5
The
EHR
RA
mus
t sup
port
arch
ivin
g (5
.4)
open
EHR
EH
R R
M:
The ‘
cont
ribut
ion’
conc
ept,
impl
emen
ted
with
ver
sion
ed COMPOSITIONs
whi
ch co
ntai
n a AUDIT_DETAILS
for e
ach
chan
ge e
nabl
e ea
ch su
cces
sive
cha
nge
to th
e EH
R to
be
unam
bigu
ousl
y id
entif
ied;
eac
h ch
ange
can
ther
efor
e be
retri
eved
and
pro
cess
ed b
y an
ar
chiv
ing
syst
em.
Des
ign:
Ful
l
ISO
Sec
tion
1.2.
1St
ruct
ured
Dat
a
ISO
Sec
tion
1.2.
2N
on-s
truc
ture
d da
ta
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
2.1
The E
HR
RA
mus
t ena
ble s
tora
ge o
f dat
a as l
ists
such
that
the o
rder
of th
e da
ta is
pre
serv
ed w
hen
the
data
is d
ispl
ayed
. (1.
2.1)
open
EHR
Dat
a St
ruct
ures
RM
:ITEM_LIST
subt
ype
of ITEM_STRUCTURE
.D
esig
n: F
ull
Val:
GEH
RST
R2.
2Th
e EH
RR
A m
ust e
nabl
e st
orag
e of
dat
a in
tabl
es su
ch th
at th
e re
-la
tions
hips
of t
he d
ata
with
the
row
and
col
umn
head
ings
are
pre
-se
rved
. (1.
2.1)
open
EHR
Dat
a St
ruct
ures
RM
:ITEM_TABLE
subt
ype
of ITEM_STRUCTURE
.D
esig
n: F
ull
Val:
GEH
R
STR
2.3
The
EHR
RA
mus
t ena
ble
stor
age
of d
ata
in h
iera
rchi
es s
uch
that
the
rela
tions
hip
betw
een
the
node
par
ents
and
chi
ldre
n ar
e pr
e-se
rved
. (1.
2.1)
open
EHR
Dat
a St
ruct
ures
RM
:ITEM_TREE
subt
ype
of ITEM_STRUCTURE
.D
esig
n: F
ull
Val:
GEH
R
STR
2.4
The
EHR
RA
mus
t ena
ble
stor
age
of d
ata
such
that
sim
ple
nam
e /
valu
e pa
iring
is p
rese
rved
. (1.
2.1)
open
EHR
Dat
a St
ruct
ures
RM
:ITEM_SINGLE
subt
ype
of ITEM_STRUCTURE
.D
esig
n: F
ull
Val:
GEH
RST
R2.
5Th
e EH
RR
A m
ust
enab
le t
he s
tora
ge o
f m
ultip
le v
alue
s of
the
sam
e m
easu
rem
ent t
aken
at c
lose
ly p
roxi
mat
e tim
es a
t the
sam
eco
ntac
t, or
at d
iffer
ent c
onta
cts a
nd at
diff
eren
t loc
atio
ns. T
he co
n-te
xt o
f the
se m
easu
rem
ents
mus
t be
pres
erve
d - s
uch
as w
ho to
okth
e m
easu
rem
ent,
wha
t met
hod
was
use
d et
c. T
hese
val
ues s
houl
dbe
abl
e to
be
retu
rned
in a
que
ry a
nd o
rder
ed in
diff
eren
t way
s.(1
.1)
open
EHR
Dat
a St
ruct
ures
RM
:cl
asse
s HISTORY<T:ITEM_STRUCTURE>
, POINT_EVENT,
INTERVAL_EVENT,
etc
. ena
ble
reco
rdin
g of
tim
e-se
ries d
ata
of
any
com
plex
ity, a
long
with
thei
r tim
es. O
ther
con
text
dat
a is
re
cord
ed o
n th
e ow
ning
OBSERVATION
. Rec
ordi
ngs b
y di
ffere
nt
peop
le, u
sing
diff
eren
t pro
toco
ls e
tc. a
re n
ot c
onsi
dere
d sc
ient
ific
time-
serie
s dat
a du
e to
var
iabi
lity
of sa
mpl
es, a
nd a
re re
cord
ed
usin
g su
cces
sive
, dis
tinct
ENTRYs
.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
2.6
The
EHR
RA
mus
t su
ppor
t th
e in
clus
ion
of n
arra
tive
free
text
and
ther
e sh
ould
be
no lo
gica
l lim
it to
the
size
of th
is te
xt. (
1.2.
2.1)
open
EHR
Dat
a Ty
pes:
DV_TEXT
and
DV_PARAGRAPH
type
s for
pla
in o
r tex
t with
bas
ic fo
nt fo
rmat
-tin
g; DV_ENCAPSULATED
for e
ncap
sula
ted
rich
text
.
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
STR
2.7
The
EHR
RA
mus
t sup
port
sear
chin
g w
ithin
non
-stru
c-tu
red
data
(tex
t and
non
-text
) and
the i
nclu
sion
of s
truc-
ture
d te
xt w
ithin
this
dat
a. (1
.2.2
.1)
open
EHR
Dat
a Ty
pes:
Sear
chin
g is
not
stric
tly a
n EH
R re
fere
nce
mod
el fa
cilit
y - i
t can
be
perf
orm
ed
on a
ny DV_TEXT
or DV_PARAGRAPH
item
, as c
onve
rted
to e
.g. X
ML
or a
ny
othe
r dat
abas
e or
repr
esen
tatio
n fo
rmat
.
The
DV_PARAGRAPH
ty
pe
can
incl
ude
any
num
ber
and
mix
ture
of
DV_CODED_TEXTs
(cod
ed te
rms)
and
DV_TEXTs
.
Des
ign:
Ful
lVa
l: G
EHR
STR
2.8
The
EHR
RA
mus
t sup
port
the
incl
usio
n of
com
men
tsw
ithin
the
data
stor
ed -
enab
ling
the
clin
icia
n to
qua
lify
stru
ctur
ed in
form
atio
n ap
prop
riate
ly. C
omm
ents
mus
tbe
abl
e to
be
linke
d to
spec
ific
data
attr
ibut
es. (
1.2.
2.2)
open
EHR
Ref
eren
ce M
odel
:C
omm
ents
are
exp
ress
ed a
s tex
t dat
a ite
ms i
n di
stin
ct ELEMENTs
in st
ruct
ured
da
ta. A
ssoc
iatin
g a
com
men
t with
a sp
ecifi
c da
tum
mea
ns u
sing
arc
hety
pes t
o de
fine
the
rele
vant
stru
ctur
e (e
.g. ITEM_TREE
etc
.) to
allo
w c
omm
ents
to b
e as
soci
ated
with
orig
inal
dat
a ite
ms.
open
EHR
doe
s not
incl
ude
a bl
anke
t fac
ility
to in
clud
e co
mm
ents
in a
ll da
ta v
al-
ue ty
pes a
s suc
h be
caus
e ex
perie
nce
has s
how
n th
at th
is k
ind
of fe
atur
e te
nds t
obe
abu
sed,
and
per
verts
cap
ture
of w
ell-s
truct
ured
dat
a (i.
e. it
allo
ws s
yste
ms t
ow
ork
arou
nd th
e in
tent
ion
of th
e m
odel
).
Des
ign:
Qua
l
STR
2.9
The
EHR
RA
mus
t pro
vide
a m
eans
for d
iffer
ent l
evel
sof
em
phas
is to
be
asso
ciat
ed w
ith c
omm
ents
and
oth
eren
tries
- th
is m
ay a
lter
the
way
they
are
dis
play
ed o
rth
eir r
etur
ning
in a
que
ry. (
1.2.
2.2)
The DV_TEXT
typ
e pr
ovid
es a
fac
ility
to
asso
ciat
e a
plat
form
-sta
ndar
d fo
ntst
ring
with
one
or m
ore
text
item
s.D
esig
n: T
BD
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
ISO
Sec
tion
1.2.
3C
linic
al D
ata
ISO
Sec
tion
1.2.
4A
dmin
istr
ativ
e da
ta
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
2.10
The
EHR
RA
mus
t allo
w fo
r com
preh
ensi
ve in
form
atio
n st
orag
e an
d re
triev
alre
gard
ing
patie
nt c
are.
The
EH
RR
A m
ust a
t a m
inim
um a
llow
for t
he re
cord
-in
g of
all
data
on:
•Pa
tient
his
tory
•Ph
ysic
al e
xam
inat
ion
•Ps
ycho
logi
cal,
soci
al, e
nviro
nmen
tal,
fam
ily, a
nd se
lf ca
re in
form
atio
n•
Alle
rgie
s and
oth
er th
erap
eutic
pre
caut
ions
•Pr
even
tativ
e an
d w
elln
ess
mea
sure
s su
ch a
s va
ccin
atio
ns a
nd li
fest
yle
inte
rven
tions
•D
iagn
ostic
test
s an
d th
erap
eutic
inte
rven
tions
suc
h as
med
icat
ions
and
proc
edur
es•
Clin
ical
obs
erva
tions
, int
erpr
etat
ions
, dec
isio
ns, a
nd c
linic
al re
ason
ing
•R
eque
sts/
orde
rs fo
r fur
ther
inve
stig
atio
n, tr
eatm
ents
, or d
isch
arge
•
Prob
lem
s, di
agno
ses,
issu
es, c
ondi
tions
, pre
fere
nces
and
exp
ecta
tions
•H
ealth
care
pla
ns, h
ealth
and
func
tiona
l sta
tus,
and
heal
th su
mm
arie
s•
Dis
clos
ures
and
con
sent
s•
Supp
liers
, mod
el a
nd m
anuf
actu
rer o
f dev
ices
(e.g
. im
plan
ts o
r pro
sthe
-se
s)
open
EHR
EH
R R
M:
All
of th
ese c
ateg
orie
s exc
ept “
Dis
clos
ures
and
cons
ents
”w
ould
be
reco
rded
by
the
norm
al m
eans
in COMPOSI-
TIONs
(m
ostly
“pe
rsis
tent
” COMPOSITIONs
), w
hich
can
be th
emat
ical
ly d
efin
ed a
s req
uire
d.
“Dis
clos
ures
” ar
e no
t stri
ctly
par
t of t
he o
penE
HR
EH
Rm
odel
, but
wou
ld b
e re
cord
ed in
the
EHR
sys
tem
(i.e
.op
enEH
R h
as n
o pa
rticu
lar m
odel
for h
ow d
iscl
osur
es ar
ere
cord
ed).
“con
sent
s” a
re e
xpre
ssed
usi
ng i
nsta
nces
of
the IN-
STRUCTION
ENTRY
sub
type
, and
may
als
o be
fur
ther
used
by
an a
cces
s co
ntro
l ser
vice
in m
edia
ting
acce
ss to
the
EHR
.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
2.11
The
EHR
RA
mus
t sup
port
the
reco
rdin
g (a
nd c
lass
ifyin
g fo
rid
entif
icat
ion
purp
oses
) of
pat
ient
ide
ntifi
catio
n, l
ocat
ion,
dem
ogra
phic
, con
tact
, em
ploy
men
t and
oth
er a
dmin
istra
tive
data
. (1.
3.3)
open
EHR
Dem
ogra
phic
RM
:Th
e de
mog
raph
ic m
odel
def
ines
the
cla
ss PARTY
and
var
ious
sub
-ty
pes,
all a
rche
typa
ble
to w
hate
ver p
artic
ular
form
is re
quire
d.
Des
ign:
Ful
lVa
l: C
EN, G
EHR
, SN
X
ISO
Sec
tion
1.3
Type
and
form
of d
ata
STR
2.12
The
EHR
RA
mus
t sup
port
stan
dard
s fo
r inf
orm
atio
n w
hich
enab
le th
e un
ambi
guou
s ide
ntifi
catio
n of
the
subj
ect o
f car
e,th
e cl
inic
ians
invo
lved
in c
are
(incl
udin
g th
eir r
ole
and
con-
text
of c
are)
, the
loca
tion
of c
are,
the
date
/tim
e an
d du
ratio
nof
car
e, a
nd th
ird p
artie
s suc
h as
nex
t of k
in a
nd n
on-c
linic
alco
ntac
ts. T
here
sho
uld
be n
o lim
it on
the
stor
age
of s
uch
in-
form
atio
n. (1
.3.3
)
open
EHR
Dem
ogra
phic
RM
:Th
e de
mog
raph
ic m
odel
def
ines
the
cla
ss PARTY
and
var
ious
sub
-ty
pes,
all a
rche
typa
ble
to w
hate
ver p
artic
ular
form
is re
quire
d.
open
EHR
EH
R R
M:
The PARTY_PROXY
cla
sses
def
ined
in th
e rm.common.generic
pack
age
prov
ide
a fle
xibe
mec
hani
sm to
incl
ude
zero
or m
ore
iden
tifi-
ers
for p
atie
nts,
whi
le e
nsur
ing
that
it is
cle
ar w
hen
the
subj
ect o
f the
reco
rd is
bei
ng in
dica
ted
(usi
ng th
e PARTY_SELF
cla
ss).
The
clas
s EVENT_CONTEXT
, and
the
cont
ext a
ttrib
utes
of t
he ENTRY
clas
s de
fine
all o
f the
attr
ibut
es m
entio
ned.
Bot
h cl
asse
s ca
n in
clud
eun
limite
d fu
rther
con
text
dat
a, w
ith m
eani
ng d
efin
ed b
y ar
chet
ypin
g.
Des
ign:
Ful
lVa
l: C
EN, G
EHR
, SN
X
STR
2.13
The
EHR
RA
mus
t sup
port
the
adm
inis
tratio
n of
hea
lthca
repr
oces
ses a
nd e
piso
des o
f car
e as
wel
l as t
he o
rgan
isat
ion
ofvi
sit a
nd e
ncou
nter
dat
a. (1
.3.3
)
open
EHR
EH
R R
M:
Epis
odes
can
be
repr
esen
ted
usin
g FOLDERs
for
gro
upin
g al
l eve
ntco
mpo
sitio
ns w
hich
occ
ur d
urin
g an
epi
sode
. Enc
ount
ers
are
repr
e-se
nted
usi
ng “
even
t” COMPOSITIONs
.
Des
ign:
Ful
l
STR
2.14
The E
HR
RA
mus
t sup
port
the r
ecor
ding
of f
inan
cial
and
oth-
er c
omm
erci
al in
form
atio
n su
ch a
s hea
lth p
lan
enro
lmen
t, el
-ig
ibili
ty a
nd c
over
age
info
rmat
ion,
gua
rant
or, c
osts
, cha
rges
,an
d ut
ilisa
tion.
(1.3
.3)
open
EHR
EH
R R
M:
All
of th
ese i
tem
s can
be r
ecor
ded
as p
ersi
sten
t Com
posi
tions
usi
ng ap
-pr
opria
tely
des
igne
d ar
chet
ypes
, alth
ough
in d
istri
bute
d sy
stem
s (a
ndpa
rticu
larly
out
side
Nor
th A
mer
ica)
, thi
s inf
orm
atio
n is
mor
e lik
ely
tobe
in o
ther
syst
ems i
n th
e en
viro
nmen
t.
Des
ign:
Ful
l
STR
2.15
The
EHR
RA
mus
t sup
port
the
reco
rdin
g of
lega
l sta
tus
and
cons
ents
rele
vant
to th
e pa
tient
’s h
ealth
care
(e.g
. leg
al st
atus
of g
uard
ians
hip
orde
r, co
nsen
ts fo
r ope
ratio
ns a
nd o
ther
pro
-ce
dure
s).
open
EHR
EH
R R
M:
All
such
det
ails
can
be
mod
elle
d us
ing
arch
etyp
es w
hich
des
crib
e th
e su
bjec
t of t
he re
cord
. The
dat
a sh
ould
pro
babl
y be
reco
rded
in a
ded
i-ca
ted
pers
iste
nt C
ompo
sitio
n.
Des
ign:
Ful
l
STR
2.16
The
EHR
RA
mus
t be
amen
able
to q
uery
ing
for t
he p
urpo
seof
dat
a agg
rega
tion
to su
ppor
t inf
orm
atio
n ga
ther
ing
requ
ired
for p
opul
atio
n an
d pu
blic
hea
lth in
itiat
ives
, sur
veill
ance
, and
repo
rting
.
open
EHR
EH
R R
M &
arc
hety
pes:
Arc
hety
pes p
rovi
de th
e ba
sis f
or fo
rmul
atin
g in
telli
gent
que
ries.
As
long
as i
nfor
mat
ion
whi
ch is
of i
nter
est i
n po
pula
tion
quer
ies (
e.g.
lif
esty
le, c
hron
ic d
isea
se e
tc.)
has b
een
stor
ed u
sing
arc
hety
pes i
n th
e fir
st p
lace
, ver
y ef
ficie
nt q
uery
ing
is p
ossi
ble,
bas
ed o
n th
e us
e of
pa
ths e
xtra
cted
from
arc
hety
pes.
Des
ign:
Qua
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
ISO
Sec
tion
1.3.
1Su
ppor
t for
diff
eren
t typ
es o
f dat
a
ISO
Sec
tion
1.3.
2D
ata
type
sTh
e EH
RR
A m
ust d
efin
e th
e fo
llow
ing
data
type
s:
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
3.1
The
EHR
RA
mus
t allo
w fo
r the
inco
rpor
atio
n of
dat
a ty
pes d
efin
ed e
lse-
whe
re, s
uch
as D
ICO
M, M
IME,
EK
G. (
1.3.
1)op
enEH
R D
ata
Type
s:Th
e DV_ENCAPSULATED
typ
e ca
ters
for
all
data
typ
es d
e-fin
ed in
oth
er st
anda
rds.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
3.2
Num
eric
and
Qua
ntifi
able
dat
a.Th
e EH
RR
A m
ust s
uppo
rt th
e de
finiti
on o
f the
logi
cal s
truct
ure
of n
u-m
eric
and
qua
ntifi
able
dat
a, in
clud
ing
the
hand
ling
of u
nits
. (1.
3.4.
2)
open
EHR
Dat
a Ty
pes:
DV_QUANTITY
(inc
ludi
ng u
nits
), DV_CUSTOMARY_QUANTITY,
DV_DATE
/TIME
type
s
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
STR
3.3
Qua
ntiti
es sh
ould
incl
ude
a m
easu
re o
f pre
cisi
on re
late
d to
the
met
hod
of m
easu
rem
ent.
(1.3
.4.2
)op
enEH
R D
ata
Type
s:pr
ecis
ion
is in
clud
ed as
an at
tribu
te in
the t
ype D
V_QUANTITY.
M
ore
com
plex
mea
sure
men
t inf
orm
atio
n ca
n be
incl
uded
in th
e OBSERVATION
.pro
toco
l attr
ibut
e w
hich
is o
f typ
e ITEM_STRUCTURE
(i.e
. any
com
plex
ity)
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
STR
3.4
Perc
enta
ges m
ust b
e ab
le to
be
expr
esse
d as
qua
ntiti
es. (
1.3.
4.2)
open
EHR
Dat
a Ty
pes:
Perc
ent i
s a v
alid
uni
t in
the
Uni
fied
Cod
e fo
r Uni
ts o
f Mea
sure
(U
CU
M) s
peci
ficat
ion
[7],
whi
ch p
rovi
des t
he se
man
tics f
or
units
in th
e DV_QUANTIFIED
type
s.
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
STR
3.5
Qua
ntity
rang
esTh
e EH
RR
A m
ust
supp
ort
the
defin
ition
of
the
logi
cal
stru
ctur
e of
rang
es -
that
is h
igh
and
low
val
ues.
(1.3
.4.2
)
open
EHR
Dat
a Ty
pes:
Ran
ges a
re p
rovi
ded
for w
ith th
e DV_INTERVAL<T:DV_ORDERED>
type
, whi
ch c
ater
s for
ra
nges
of a
ny o
rder
ed d
ata
type
s.
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
STR
3.6
Qua
ntity
ratio
sTh
e EH
RR
A m
ust
supp
ort
the
defin
ition
of
the
logi
cal
stru
ctur
e of
quan
tity
ratio
s (i.e
. x o
f a p
er y
of b
). (1
.3.4
.2)
open
EHR
Dat
a Ty
pes:
The DV_QUANTITY_RATIO
type
pro
vide
s for
ratio
s of t
he
form
<{v
al_1
, uni
ts_1
}/{v
al_2
, uni
ts_2
}>. W
hat t
he q
uant
ities
ar
e of
can
be
reco
rded
in th
e na
me
or in
an
asso
ciat
ed a
ttrib
ute,
bu
t are
not
reco
rded
insi
de th
e qu
antit
y ra
tio d
ata
item
as s
uch.
Des
ign:
Qua
lVa
l: C
EN,
GEH
R, S
NX
STR
3.7
Dat
es a
nd ti
mes
The
EHR
RA
mus
t su
ppor
t th
e de
finiti
on o
f th
e lo
gica
l st
ruct
ure
ofda
tes a
nd ti
mes
. (1.
3.4.
3)
open
EHR
Dat
a Ty
pes:
The
subt
ypes
of DV_CUSTOMARY_QUANTITY,
pro
vide
for
date
s and
tim
es, n
amel
y DV_DATE
, DV_TIME
, DV_DATE_TIME
, DV_DURATION
, whi
ch a
re a
ll IS
O86
01-
com
plia
nt.
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
STR
3.8
The
EHR
RA
mus
t sup
port
appr
oxim
ate,
par
tial,
and
fuzz
y da
tes
and
times
such
as:
•ap
prox
imat
e da
tes/
times
: e.g
., so
met
ime
yest
erda
y, la
st w
eek;
•pa
rtial
dat
es: e
.g. ?
?/M
ay/1
997,
??/
??/1
928
open
EHR
EH
R R
M /
Dat
a ty
pes:
Thes
e re
quire
men
ts a
re sa
tisfie
d w
ith th
e fo
llow
ing
elem
ents
of
the
open
EHR
mod
els:
•te
xt d
ata
type
s•
the
date
/tim
e ty
pes
whi
ch a
re I
SO86
01-c
ompl
iant
and
supp
ort p
artia
l dat
es, t
imes
, dat
e_tim
es a
nd d
urat
ions
.
Des
ign:
Qua
lD
esig
n: F
ull
STR
3.9
The E
HR
RA
mus
t sup
port
the r
ecor
ding
of f
utur
e pla
nned
even
ts o
r ac-
tions
such
as:
•pe
riods
of
day
or ti
me:
e.g
., m
orni
ng, a
ftern
oon,
eve
ning
, shi
fts(A
M, P
M, N
OC
), w
hile
aw
ake;
•po
ints
of
time:
e.g
., up
on a
wak
enin
g, a
t m
ealti
me
(bre
akfa
st,
lunc
h, d
inne
r), a
t bed
time;
•re
lativ
e po
ints
of d
ay o
r tim
e: e
.g.,
befo
re b
reak
fast
, afte
r lun
ch,
befo
re b
edtim
e, t
wo
days
pos
t di
scha
rge,
one
wee
k af
ter
last
dose
;•
alte
rnat
ing
and
patte
rned
dat
es/ti
mes
: e.
g.,
alte
rnat
e ev
ery
8ho
urs,
alte
rnat
e ev
ery
3 da
ys, e
very
Mon
day/
Wed
nesd
ay/F
riday
,ev
ery
Sund
ay, e
very
third
Tue
sday
. (1.
3.4.
3)
open
EHR
EH
R R
M /
Dat
a ty
pes:
Thes
e re
quire
men
ts a
re sa
tisfie
d w
ith th
e fo
llow
ing
elem
ents
of
the
open
EHR
mod
els:
•DV_INTERVAL<>
of
an
y da
te/ti
me
type
;DV_TIME_SPECIFICATION
type
•DV_TIME_SPECIFICATION
(with
eve
nt a
lignm
ent)
•DV_TIME_SPECIFICATION
. One
wee
k af
ter l
ast d
ose:
HISTORY<T>
with
refe
renc
e ev
ent s
et to
“la
st d
ose”
•DV_TIME_SPECIFICATION
Des
ign:
Ful
l
Des
ign:
Ful
l
Des
ign:
Ful
l
Des
ign:
Ful
l
STR
3.10
The
EHR
RA
mus
t sup
port
the r
ecor
ding
of t
ime
as an
abs
olut
e tim
e, a
nel
apse
d tim
e si
nce
a pa
rticu
lar e
vent
, and
as a
dur
atio
n. (1
.3.4
.3)
open
EHR
Dat
a ty
pes:
Abs
olut
e tim
e: DV_DATE_TIME
; ela
psed
tim
e:
DV_DURATION
.
open
EHR
EH
R R
M:
HISTORY<T>
allo
ws
even
ts to
be
reco
rded
with
res
pect
to a
refe
renc
e ev
ent.
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
STR
3.11
The
EHR
RA
mus
t sup
port
the
reco
rdin
g of
the
time-
zone
in w
hich
the
reco
rdin
g to
ok p
lace
. (1.
3.4.
3)op
enEH
R D
ata
type
s:Ti
mez
one
is a
n at
tribu
te o
f DV_DATE_TIME
DV_DATE
, and
DV_TIME
.
Des
ign:
Ful
l
STR
3.12
The
EHR
RA
mus
t sup
port
reco
rdin
g of
tim
e in
all
units
dow
n to
mill
i-se
cond
s. (1
.3.4
.3)
open
EHR
Dat
a ty
pes:
All
date
/tim
e ty
pes s
uppo
rt m
illis
econ
ds.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
ISO
Sec
tion
1.3.
3R
efer
ence
dat
a
ISO
Sec
tion
1.3.
4C
onte
xtua
l Dat
a
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
3.1
3Th
e EH
RR
A m
ust s
uppo
rt th
e re
cord
ing
of re
fere
nces
suc
h as
nor
mal
rang
es a
nd a
ttrib
utes
rel
evan
t to
a pa
rticu
lar
obse
rvat
ion
or m
easu
re-
men
t. (1
.3.5
)
open
EHR
Dat
a ty
pes:
DV_ORDERED
.refe
renc
e_ra
nges
and
nor
mal
_ran
ge
attri
bute
s.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
3.1
4Th
e EH
RR
A m
ust s
uppo
rt th
e re
cord
ing
of c
onte
xtua
l dat
a as
so-
ciat
ed w
ith th
e da
te/ti
me
the
even
t occ
urre
d.op
enEH
R E
HR
RM
:EH
R R
M a
ttrib
ute HISTORY.
orig
in, EVENT.
offs
etD
esig
n: F
ull
STR
3.1
5Th
e EH
RR
A m
ust s
uppo
rt th
e re
cord
ing
of c
onte
xtua
l dat
a as
so-
ciat
ed w
ith th
e da
te/ti
me
the
even
t was
com
mitt
ed to
the
reco
rd.
open
EHR
EH
R R
M:
EHR
RM
attr
ibut
e AUDIT_DETAILS
.tim
e_co
mm
itted
Des
ign:
Ful
l
STR
3.1
6Th
e EH
RR
A m
ust s
uppo
rt th
e re
cord
ing
of c
onte
xtua
l dat
a as
so-
ciat
ed w
ith th
e su
bjec
t.op
enEH
R E
HR
RM
:EH
R R
M a
ttrib
ute ENTRY.
subj
ect
Des
ign:
Ful
l
STR
3.1
7Th
e EH
RR
A m
ust s
uppo
rt th
e re
cord
ing
of c
onte
xtua
l dat
a as
so-
ciat
ed w
ith th
e pe
rson
res
pons
ible
for
rec
ordi
ng a
nd c
omm
ittin
gth
e ev
ent.
open
EHR
EH
R R
M:
EHR
RM
attr
ibut
e ENTRY.
prov
ider
(= in
form
atio
n pr
ovid
er)
EHR
RM
attr
ibut
e EVENT_CONTEXT.
com
pose
rEH
R R
M a
ttrib
ute AUDIT_DETAILS
.com
mitt
er
Des
ign:
Ful
l
STR
3.1
8Th
e EH
RR
A m
ust s
uppo
rt th
e re
cord
ing
of c
onte
xtua
l dat
a as
so-
ciat
ed w
ith th
e he
alth
care
faci
lity.
open
EHR
EH
R R
M:
EHR
RM
attr
ibut
e EVENT_CONTEXT.
heal
th_c
are_
faci
lity
Des
ign:
Ful
l
STR
3.1
9Th
e EH
RR
A m
ust s
uppo
rt th
e re
cord
ing
of c
onte
xtua
l dat
a as
so-
ciat
ed w
ith th
e lo
catio
n w
here
the
even
t was
reco
rded
.op
enEH
R E
HR
RM
:EH
R R
M a
ttrib
ute EVENT_CONTEXT.
loca
tion
Des
ign:
Ful
l
STR
3.2
0Th
e EH
RR
A m
ust s
uppo
rt th
e re
cord
ing
of c
onte
xtua
l dat
a as
so-
ciat
ed w
ith t
he r
easo
n fo
r re
cord
ing
the
info
rmat
ion
asso
ciat
edw
ith th
e ev
ent.
open
EHR
EH
R R
M:
EHR
RM
attr
ibut
e CARE_ENTRY.
guid
elin
e_id
Des
ign:
Par
tial
STR
3.2
1Th
e EH
RR
A m
ust s
uppo
rt th
e re
cord
ing
of c
onte
xtua
l dat
a as
so-
ciat
ed w
ith th
e pr
otoc
ol a
ssoc
iate
d w
ith th
e ev
ent.
open
EHR
EH
R R
M:
EHR
RM
attr
ibut
e CARE_ENTRY.
prot
ocol
Des
ign:
Ful
l
ISO
Sec
tion
1.3.
5Li
nks
ISO
Sec
tion
1.4
Supp
ortin
g he
alth
con
cept
repr
esen
tatio
n
ISO
Sec
tion
1.4.
1Su
ppor
t for
mul
tiple
cod
ing
syst
ems
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
3.2
2Th
e EH
RR
A m
ust d
efin
e th
e se
man
tic re
pres
enta
tion
of li
nks
betw
een
diff
eren
t inf
orm
atio
n in
the
EHR
. (1.
3.7)
open
EHR
Dat
a ty
pes:
LINK
dat
a ty
pe, i
nclu
ding
mea
ning
attr
ibut
e.D
esig
n: F
ull
Val:
CEN
, GEH
R,
SNX
STR
3.2
3Th
e EH
RR
A m
ust s
uppo
rt lin
ks to
'ext
erna
lly re
fere
nced
dat
a'w
hich
is n
ot a
ble
to b
e st
ored
with
in th
e EH
R, p
rovi
ding
pa-
tient
safe
ty is
not
com
prom
ised
. (1.
3.7)
open
EHR
EH
R R
M:
The DV_EHR_URI
type
can
refe
renc
e an
y co
mpl
ex d
ata
(e.g
. dem
o-gr
aphi
c, te
rmin
olog
ical
) in
exte
rnal
repo
sito
ries.
open
EHR
Dat
a Ty
pes:
DV_ENCAPSULATED
can
incl
ude
a U
RL
for i
ts d
ata
item
whi
ch is
not i
nclu
ded
by v
alue
in th
e EH
R;
DV_TEXT
can
incl
ude
a U
RL
as a
hyp
erlin
k fo
r a se
ctio
n of
nar
rativ
ete
xt.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
4.1
The E
HR
RA
mus
t sup
port
mul
tiple
codi
ng sy
stem
s (en
tryor
int
erfa
ce t
erm
inol
ogie
s, re
fere
nce
term
inol
ogie
s an
dcl
assi
ficat
ions
) by
cre
atin
g in
terf
aces
with
ele
ctro
nic
tool
s su
ch a
s te
rmin
olog
y br
owse
rs, t
erm
inol
ogy
edito
rsan
d te
rmin
olog
y se
rver
s. (1
.4.1
)
The
open
EHR
mod
els d
o th
is in
seve
ral w
ays.
Cod
ed te
rms i
n EH
R d
ata
are
repr
esen
ted
usin
g th
e DV_CODED_TEXT
type
, whi
ch re
cord
s the
iden
tity
ofth
e te
rmin
olog
y fr
om w
hich
cod
es c
ome,
usi
ng a
TERMINOLOGY_ID
ob-
ject
. The
ids a
nd c
odes
refe
r to
iden
tifie
rs a
nd te
rms i
n th
e op
enEH
R T
erm
i-no
logy
Mod
el,
whi
ch m
odel
s th
e m
inim
um s
eman
tics
of t
he i
nter
face
betw
een
the
EHR
and
term
inol
ogie
s.
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
STR
4.2
At t
he d
ata
attri
bute
leve
l, th
e EH
RR
A m
ust s
uppo
rt th
eca
ptur
e of
the
code
, the
cod
ing
sche
me
(e.g
., co
ding
/cla
s-si
ficat
ion
syst
em),
vers
ion
and
orig
inal
lang
uage
.
open
EHR
Dat
a Ty
pes:
The DV_CODED_TEXT
& CODE_PHRASE
type
s rec
ord
code
, rub
ric (t
extu
-al
exp
ansi
on)
and
term
inol
ogy_
id.
Orig
inal
lan
guag
e is
rec
orde
d in
the
COMPOSITION
leve
l in ENTRYs
.
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
STR
4.3
The
EHR
RA
mus
t ena
ble
stor
age
of d
ata
from
term
inol
o-gi
es a
nd p
rese
rve
the
info
rmat
ion
abou
t the
term
inol
ogy
set
from
whi
ch i
t w
as c
hose
n (s
ee s
ectio
n 1.
4 be
low
).(1
.2.1
)
open
EHR
Dat
a Ty
pes &
EH
R R
M:
CODE_PHRASE
.term
inol
ogy_
id: TERMINOLOGY_ID
.D
esig
n: F
ull
ISO
Sec
tion
1.4.
2U
niqu
e re
pres
enta
tion
of in
form
atio
n
ISO
Sec
tion
1.4.
3La
ngua
ge in
depe
nden
ce
ISO
Sec
tion
1.4.
4R
epre
sent
atio
n of
text
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
4.4
Whe
re in
form
atio
n is
not
repr
esen
ted
uniq
uely
in o
nly
one
plac
e an
d on
e w
ay, t
heEH
RR
A s
hall
supp
ort e
xplic
it ru
les
to a
void
am
bigu
ity (e
.g. i
s m
ust b
e cl
ear w
hat
[not
] [pe
dal p
ulse
s abs
ent]
mea
ns).
open
EHR
arc
hety
pes p
rovi
de th
e se
man
tic d
efi-
nitio
n of
dat
a, in
clud
ing
varia
nt w
ays o
f rec
ord-
ing
the
sam
e da
ta. N
egat
ion
in p
artic
ular
is
reco
rded
usi
ng “
excl
usio
n” a
rche
type
s.
Des
ign:
Ful
l
STR
4.5
The
EHR
RA
mus
t sup
port
a m
eans
of m
appi
ng b
etw
een
obje
cts i
n in
form
atio
n an
din
fere
nce
mod
els
corr
espo
ndin
g to
a w
ell-d
efin
ed s
et o
f con
cept
s in
the
foun
datio
nre
fere
nce
term
inol
ogy
(or c
once
pt) m
odel
. (1.
4.1)
open
EHR
Dat
a Ty
pes D
V_CODED_TEXT
and
TERM_MAPPING
type
s.D
esig
n: F
ull
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
4.6
The
EHR
RA
mus
t sup
port
the
use
of a
com
preh
ensi
ve re
fere
nce
term
inol
ogy
that
ena
bles
the
reco
rdin
g/tra
nsla
tion
of m
ultil
ingu
al te
rms.
[Thi
s doe
s not
im-
ply
that
a g
iven
EH
R im
plem
enta
tion
mus
t sup
port
mor
e th
an o
ne la
ngua
ge].
Lang
uage
is re
cord
ed in
DV_TEXT
inst
ance
s;
bran
chin
g ve
rsio
n co
ntro
l allo
ws t
rans
latio
ns o
f co
mpl
ete
Com
posi
tions
to b
e re
cord
ed a
long
side
the
vers
ion
in th
e or
igin
al la
ngua
ge.
Des
ign:
Ful
l
STR
4.7
The E
HR
RA
mus
t sup
port
the i
dent
ifica
tion
of in
form
atio
n th
at h
as b
een
trans
-la
ted
from
the l
angu
age i
n w
hich
it w
as o
rigin
ally
reco
rded
. Suc
h id
entif
icat
ion
mus
t des
crib
e th
e fa
ithfu
lnes
s or r
elia
bilit
y of
the
trans
latio
n. (1
.4.3
)
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
STR
4.8
The
orig
inal
text
ual r
epre
sent
atio
n as
ent
ered
by
the
clin
icia
n m
ust
be re
tain
ed in
the
EHR
whe
n in
form
atio
n is
tran
slat
ed fr
om o
ne n
at-
ural
lang
uage
to a
noth
er o
r whe
n te
rms
are
map
ped
from
one
cod
-in
g/cl
assi
ficat
ion
syst
em to
ano
ther
.
Tran
slat
ion
caus
es b
ranc
hed
vers
ioni
ng in
the
open
EHR
EH
R,
ensu
ring
that
the
orig
inal
dat
a ar
e no
t obs
cure
d. T
erm
map
ping
is
supp
orte
d vi
a th
e TERM_MAPPING
type
.
Des
ign:
Ful
l
ISO
Sec
tion
2PR
OC
ESS
Prea
mbl
eTh
e EH
RR
A m
ust s
uppo
rt cl
inic
al p
roce
sses
such
as o
rder
ing,
car
e pl
anni
ng, c
linic
al g
uide
lines
, and
dec
isio
n su
ppor
t. It
mus
t als
o su
ppor
t pro
cess
es a
ssoc
iate
d di
rect
lyw
ith th
e re
cord
incl
udin
g th
e ca
ptur
e, re
triev
al, q
uery
ing,
pre
sent
atio
n, a
nd a
utom
atic
pro
cess
ing
of p
atie
nt d
ata.
Goo
d qu
ality
dat
a is
ess
entia
l for
goo
d qu
ality
dec
isio
nsu
ppor
t and
mos
t oth
er a
spec
ts o
f pat
ient
car
e, s
o un
iform
dat
a ca
ptur
e m
etho
ds a
nd d
ata
defin
ition
s sh
ould
be
used
whe
neve
r pos
sibl
e in
EH
R s
yste
ms.
The
EHR
RA
shou
ld a
lso
supp
ort l
ocal
clin
ical
and
wor
kflo
w p
roce
sses
to e
nsur
e m
axim
um u
sabi
lity
and
acce
ptab
ility
of E
HR
syst
ems b
y cl
inic
ians
and
oth
er u
sers
.
ISO
Sec
tion
2.1
Clin
ical
pro
cess
es
ISO
Sec
tion
2.1.
1Su
ppor
t for
clin
ical
pro
cess
es
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
1.1
The
EHR
RA
mus
t sup
port
the
reco
rdin
g of
any
type
of
clin
ical
eve
nt, e
ncou
nter
, or e
piso
de re
leva
nt to
the
care
of a
pat
ient
(3.1
)
The
open
EHR
mod
els
are
gene
ric in
nat
ure,
and
do
not d
irect
ly m
odel
con
-ce
pts
such
as
“enc
ount
er”
or “
epis
ode”
- th
ese
are
mod
elle
d by
usi
ng a
rche
-ty
pes, FOLDERs
, COMPOSITIONs
and
oth
er e
lem
ents
of
the
arch
itect
ure.
All
clin
ical
eve
nts
resu
lt in
an
“eve
nt” COMPOSITION
, whi
ch c
onta
ins
rele
-va
nt c
onte
xt in
an
atta
ched
EVENT_CONTEXT
obj
ect.
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
PRO
1.2
The
EHR
RA
mus
t su
ppor
t th
e cr
eatio
n, i
nsta
ntia
tion,
and
mai
nten
ance
of
clin
ical
pro
cess
es t
hat
supp
ort
the
activ
ities
of i
ts u
sers
(3.3
.5)
open
EHR
EH
R R
M:
Arc
hety
pes
can
be u
sed
to d
efin
e sp
ecifi
c st
ruct
ures
of
the
vario
us k
inds
of
ENTRY
(ADMIN_ENTRY
, OBSERVATION
, EVALUATION
, INSTRUCTION
,an
d ACTION)
and
link
s be
twee
n th
em d
escr
ibin
g ca
usal
ity o
r oth
er re
latio
n-sh
ips.
As m
ore e
vent
s hap
pen
in a
clin
ical
pro
cess
, cha
nges
to th
e sta
tes o
f IN-
STRUCTIONs
/ACTIONs
and
the
addi
tion
of li
nks
can
be m
ade,
cre
atin
g a
grow
ing
pict
ure o
f the
real
-wor
ld p
roce
ss as
it u
nfol
ds in
tim
e. In
tegr
atio
n w
ithfo
rmal
wor
kflo
w sy
stem
s is s
uppo
rted
in INSTRUCTION
and
ACTION
.
Des
ign:
Ful
l
PRO
1.3
The
EHR
RA
mus
t su
ppor
t th
e co
ntin
uity
of
a cl
inic
alpr
oces
s, th
e ab
ility
to q
uery
the
stat
us o
f a p
roce
ss, m
od-
ify an
exis
ting
proc
ess,
and
verif
y th
at a
proc
ess h
as b
een
com
plet
ed (3
.3.5
)
open
EHR
EH
R R
M:
The INSTRUCTION
type
allo
ws
the
stat
e of
fine
-gra
ined
pro
cess
es to
be
re-
cord
ed u
sing
the DV_STATE
dat
a ty
pe. T
he s
tate
mac
hine
s ar
e de
fined
in a
r-ch
etyp
es. W
hen
a pr
oces
s cha
nges
stat
e, a
new
ver
sion
of a
COMPOSITION
ism
ade
whi
ch re
cord
s the
stat
e ch
ange
.
The
stat
us o
f coa
rse-
grai
ned
proc
esse
s suc
h as
car
e-pl
ans i
s mor
e lik
ely
to b
ere
cord
ed b
y cl
inic
ians
as n
arra
tive.
Des
ign:
Ful
l
PRO
1.4
The
EHR
RA
mus
t be
able
to a
ccom
mod
ate
parti
al c
om-
plet
ion
of a
clin
ical
pro
cess
. (3.
3.5)
open
EHR
EH
R R
M:
The INSTRUCTION
typ
e in
clud
es a
sta
ndar
d “I
nstru
ctio
n St
ate
Mac
hine
”w
hose
sta
ndar
d st
ates
can
be
map
ped
to w
orkf
low
ste
p na
mes
in p
artic
ular
clin
ical
wor
kflo
ws i
n ar
chet
ypes
.
Des
ign:
Ful
l
ISO
Sec
tion
2.1.
2Pr
oble
ms/
issu
es a
nd h
ealth
sta
tus
ISO
Sec
tion
2.1.
3C
linic
al re
ason
ing
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
1.5
The
EHR
RA
mus
t su
ppor
t th
e re
cord
ing
and
pres
enta
tion
of h
olis
tiche
alth
stat
us, f
unct
iona
l sta
tus,
prob
lem
s, co
nditi
ons,
envi
ronm
enta
l cir-
cum
stan
ces a
nd is
sues
(3.2
.1)
open
EHR
EH
R R
M:
all o
f the
se w
ould
be
reco
rded
in th
e ap
prop
riate
“pe
rsis
t-en
t” C
ompo
sitio
ns, a
ccor
ding
to a
ppro
pria
te a
rche
type
s.
Des
ign:
Ful
lVa
l: G
EHR
PRO
1.6
The
EHR
RA
mus
t sup
port
the
reco
rdin
g an
d pr
esen
tatio
n of
dat
a in
apr
oble
m-o
rient
ed s
truct
ure
incl
udin
g pr
oble
m s
tatu
s, re
solu
tion
plan
san
d ta
rget
s (p
robl
em-o
rient
ed h
ere
incl
udes
con
ditio
ns a
nd i
ssue
s)(3
.2.1
)
open
EHR
EH
R R
M:
parti
cula
r ty
pes
of p
ersi
sten
t C
ompo
sitio
n ar
e us
ed t
ore
cord
pro
blem
lis
t, is
sues
, car
e pl
ans
etc.
; ap
prop
riate
Sect
ion
arch
etyp
es a
re u
sed
to s
uppo
rt pr
oble
m-o
rient
edre
cord
ing.
Des
ign:
Ful
lVa
l: G
EHR
PRO
1.7
The
EHR
RA
mus
t sup
port
a pa
tient
's lif
etim
e, lo
ngitu
dina
l rec
ord
ofhe
alth
sta
tus
and
care
inte
rven
tions
whi
ch c
an b
e vi
ewed
as
a ch
rono
-lo
gica
l hea
lth re
cord
. The
pat
ient
EH
R is
at o
nce
(sim
ulta
neou
sly)
:1.
retro
spec
tive:
an
hist
oric
al v
iew
of
heal
th s
tatu
s an
d in
terv
en-
tions
(e.g
., co
mpl
eted
hea
lth se
rvic
e ev
ents
/act
s);
2.co
ncur
rent
: a
"now
" vi
ew o
f he
alth
sta
tus
and
activ
e in
terv
en-
tions
(e.g
., he
alth
serv
ice
even
ts/a
cts n
ow u
nder
way
); an
d3.
pros
pect
ive:
a f
utur
e vi
ew o
f pl
anne
d in
terv
entio
ns (
e.g.
, hea
lthse
rvic
e ev
ents
/act
s sch
edul
ed o
r pen
ding
).
The o
penE
HR
mod
els a
re d
esig
ned
to ex
pres
s the
sem
an-
tics o
f a lo
ngitu
dina
l EH
R, a
nd a
re b
ased
on
a nu
mbe
r of
core
des
ign
prin
cipl
es [2
].
The
thre
e vi
ews
are
supp
orte
d by
fiv
e su
btyp
es o
f EN-
TRY
, na
mel
y OBSERVATION
, EVALUATION
, IN-
STRUCTION
, ACTION
an
d ADMIN_ENTRY
ty
pes
whi
ch a
re b
ased
on
som
e ye
ars
of r
esea
rch
and
expe
ri-en
ce, i
nclu
ding
by
GEH
R, P
EN&
PAD
(U. M
anch
este
r),
and
by C
EN a
nd H
L7.
Des
ign:
Ful
lVa
l: C
EN, G
EHR
, SN
X.
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
1.8
The
EHR
RA
mus
t sup
port
the
reco
rdin
g of
the
clin
ical
reas
onin
g in
clud
ing
auto
mat
ed p
roce
sses
for
all
diag
-no
ses,
conc
lusi
ons,
and
actio
ns r
egar
ding
the
care
of
apa
tient
(3.2
.2)
open
EHR
EH
R R
M:
Arc
hety
pes a
re u
sed
to d
efin
e par
ticul
ar d
iagn
oses
and
care
pla
n in
form
atio
nst
ruct
ures
. U
se o
f co
mpu
teris
ed c
linic
al g
uide
lines
is
supp
orte
d vi
a th
eCARE_ENTRY
.gui
delin
e_id
attr
ibut
e.
Des
ign:
Ful
l
ISO
Sec
tion
2.1.
4D
ecis
ion
supp
ort,
guid
elin
es, a
nd p
roto
cols
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
1.9
The
EHR
RA
mus
t sup
port
the
auto
mat
ic p
res-
enta
tion
of w
arni
ngs,
aler
ts a
nd re
min
ders
suc
has
pat
ient
inf
ectiv
e st
atus
, al
lerg
ies
and
othe
rth
erap
eutic
pre
caut
ions
, ou
tsta
ndin
g in
terv
en-
tions
, and
urg
ent r
esul
ts (3
.2.1
)
open
EHR
EH
R R
M:
Impo
rtant
item
s su
ch a
s al
lerg
ies,
prob
lem
s et
c. a
re m
ost l
ikel
y to
be
stor
ed in
asm
all
num
ber
of o
ften-
acce
ssed
“pe
rsis
tent
” C
ompo
sitio
ns i
n th
e EH
R,
each
of
whi
ch is
iden
tifie
d by
pur
pose
, e.g
. “th
erap
eutic
pre
caut
ions
”, “
prob
lem
list
” et
c.
In a
dditi
on, a
ny e
lem
ent o
f an
open
EHR
EH
R c
an b
e ac
cess
ed v
ia a
UR
I-st
yle
path
,al
low
ing
indi
vidu
al id
entif
icat
ion
of im
porta
nt it
ems.
The
actu
al d
etec
tion
and
actio
ning
of w
arni
ngs
and
aler
ts is
up
to th
e ca
lling
app
li-ca
tion,
such
as a
dec
isio
n su
ppor
t sys
tem
.
Des
ign:
Ful
l
PRO
1.1
0Th
e EH
RR
A m
ust
supp
ort
syst
emat
ic p
opul
a-tio
n-ba
sed
reca
lls a
nd re
min
ders
incl
udin
g pu
b-lic
and
pop
ulat
ion
heal
th p
rogr
ams
such
as
imm
unis
atio
n an
d ep
idem
iolo
gica
l sur
veill
ance
(3.3
.5)
open
EHR
EH
R R
M:
The INSTRUCTION
type
in th
e EH
R R
M h
as b
een
spec
ifica
lly d
esig
ned
to su
ppor
tau
tom
ated
reca
ll m
anag
emen
t, in
clud
ing
mod
ellin
g of
reca
ll ty
pes
with
indi
vidu
alar
chet
ype-
defin
ed st
ate
mac
hine
s.
Path
s to
all r
ecal
ls in
an
EHR
wou
ld b
e add
ed to
a p
ersi
sten
t Com
posi
tion
whe
n th
eyar
e fir
st d
efin
ed. T
his e
nabl
es tr
igge
rs to
be
crea
ted
for e
ach
reca
ll, b
ased
on
its st
ate
mac
hine
and
stat
e da
ta.
Des
ign:
Ful
l
PRO
1.1
1Th
e EH
RR
A m
ust b
e abl
e to
supp
ort g
uide
lines
,pr
otoc
ols,
and
deci
sion
supp
ort s
yste
ms (
3.3.
5)Th
e INSTRUCTION
type
in th
e EH
R R
M h
ave
been
spe
cific
ally
des
igne
d to
sup
-po
rt au
tom
ated
gui
delin
e in
tera
ctio
n. In
par
ticul
ar:
•pa
ths
to i
tem
s in
the
EH
R n
eede
d by
gui
delin
es c
an b
e st
ored
in
the
CARE_ENTRY.
guid
elin
e_id
obj
ect f
or th
e gu
idel
ine;
•ex
ecut
ion
stat
e of
a g
uide
line
can
be s
tore
d in
the
INSTRUCTION.
stat
eob
ject
for t
he g
uide
line.
Furth
er e
xper
ienc
e an
d te
stin
g is
nee
ded
in th
is a
rea
to d
eter
min
e w
heth
er th
e ar
chi-
tect
ure
need
s to
pro
vide
oth
er s
uppo
rt fo
r de
cisi
on s
uppo
rt an
d ot
her
auto
mat
edpr
oces
sing
.
Des
ign:
Qua
l
PRO
1.1
2Th
e EH
RR
A m
ust e
nabl
e se
man
tic in
tero
pera
-bi
lity
of c
linic
al c
once
pts
to s
uppo
rt de
cisi
onsu
ppor
t pro
cess
ing.
Arc
hety
pes c
an b
e sh
ared
bet
wee
n th
e EH
R a
nd d
ecis
ion
supp
ort s
yste
ms,
enab
ling
deci
sion
supp
ort t
o se
arch
for s
eman
tical
ly m
eani
ngfu
l con
cept
s rat
her t
han
just
at
omic
dat
a ite
ms.
Des
ign:
Qua
l
ISO
Sec
tion
2.1.
5C
are
Plan
ning
ISO
Sec
tion
2.1.
6O
rder
s &
ser
vice
pro
cess
es
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
1.1
3Th
e EH
RR
A m
ust s
uppo
rt ca
re p
lann
ing,
incl
udin
g th
e m
anag
e-m
ent
of p
roce
ss s
tate
s (e
.g.
plan
ned,
ord
ered
, sc
hedu
led,
in
prog
ress
, on
hold
, pen
ding
, com
plet
ed, a
men
ded,
ver
ified
, can
-ce
lled)
, with
in th
e ca
re p
lann
ing
proc
ess (
3.2.
4)
open
EHR
EH
R R
M:
The
EHR
RM
EVALUATION
ENTRY
subt
ype
allo
ws
plan
s to
be
expr
esse
d, w
hile
the INSTRUCTION
ENTRY
type
ena
bles
spe
cific
actio
ns to
be
pres
crib
ed. T
he in
form
atio
n de
finin
g an
y su
ch a
ctio
nis
expr
esse
d in
an ap
prop
riate
arch
etyp
e, in
clud
ing
the s
tate
mac
hine
defin
ition
for t
he p
roce
ss st
ate.
open
EHR
Dat
a Ty
pes:
The D
V_STATE
dat
a typ
e dire
ctly
impl
emen
ts th
e con
cept
of a
stat
em
achi
ne, a
nd is
des
igne
d to
be
driv
en b
y st
ate
mac
hine
s def
ined
on
a pe
r-ar
chet
ype
basi
s.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
1.1
4Th
e EH
RR
A m
ust
supp
ort
the
reco
rdin
g an
d tra
ckin
g of
clin
ical
ord
ers
and
requ
ests
suc
h as
pre
scrip
tions
and
oth
ertre
atm
ent o
rder
s, in
vest
igat
ion
requ
ests
, and
refe
rral
s (3.
3.6)
open
EHR
EH
R R
M:
orde
rs a
nd o
ther
requ
ests
are
reco
rded
usi
ng th
e INSTRUCTION
ENTRY
type
. Pre
scrip
tions
are
act
ually
doc
umen
ts c
onta
inin
g m
edic
atio
n or
der
requ
ests
from
a p
rovi
der t
o a
fille
r suc
h as
a p
harm
acy.
The
re m
ay b
e an
arbi
trary
rela
tions
hip
betw
een
med
icat
ions
and
pre
scrip
tions
from
a g
iven
clin
ical
sess
ion,
due
to a
) pre
scrip
tions
requ
ired
for d
iffer
ent f
iller
s (e.
g. a
spec
ial d
rug
may
onl
y be
ava
ilabl
e fr
om a
spe
cial
ist p
harm
acy)
, and
b)
due
to le
gisl
atio
n, e
.g. i
n A
ustra
lia, t
here
can
be
a m
axim
um o
f 3 m
edic
a-tio
ns o
n a
pres
crip
tion;
and
c) n
ot a
ll pr
opos
ed m
edic
atio
ns o
r the
rapi
esne
ed to
be
incl
uded
in a
pre
scrip
tion.
Pre
scrip
tions
sho
uld
ther
efor
e be
man
aged
sepa
rate
ly, a
nd a
re m
ost l
ikel
y to
be
repr
esen
ted
in o
penE
HR
as
sepa
rate
Com
posi
tions
, or
just
with
pre
scrip
tion
ids
from
a p
resc
ribin
gsy
stem
.
Des
ign:
Ful
l
PRO
1.1
5Th
e EH
RR
A m
ust s
uppo
rt th
e lin
king
of o
rder
s with
the
ob-
serv
atio
ns th
at a
rise
as a
resu
lt (e
.g. t
he re
sults
of a
n in
vest
i-ga
tion
or a
dmin
istra
tion
of a
med
icat
ion
with
the
orde
r for
thes
e in
terv
entio
ns).
open
EHR
EH
R R
M a
nd D
ata
Type
s:Th
e LINK
dat
a ty
pe is
pro
vide
d fo
r exa
ctly
this
pur
pose
, and
may
be
used
to c
reat
e a
nam
ed li
nk b
etw
een
any
arch
etyp
ed d
ata
entit
ies,
i.e. COMPO-
SITIONs
, SECTIONs
, ENTRYs
. Suc
h lin
ks m
ay b
e us
ed to
cre
ate
caus
-al
cha
ins o
r “pr
oble
m th
read
s” th
roug
h th
e da
ta.
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
ISO
Sec
tion
2.1.
7In
tegr
ated
car
e
ISO
Sec
tion
2.1.
8Q
ualit
y as
sura
nce
ISO
Sec
tion
2.2
Rec
ord
proc
esse
s
ISO
Sec
tion
2.2.
1D
ata
capt
ure
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
1.1
6Th
e EH
RR
A m
ust s
uppo
rt in
tegr
ated
pat
ient
car
e in
-cl
udin
g co
ntin
uing
co
llabo
rativ
e m
ulti-
disc
iplin
ary
care
and
cas
e m
anag
emen
t acr
oss
diff
eren
t hea
lthca
rese
ctor
s an
d se
tting
s (e
.g. p
rimar
y ca
re, a
cute
hos
pita
ls,
allie
d he
alth
, hom
e-ba
sed
care
) (3.
2.3)
The
open
EHR
EH
R is
agn
ostic
abo
ut w
ho re
cord
s inf
orm
atio
n in
it a
nd u
ses
it. A
cces
s and
car
e ac
ross
diff
eren
t sec
tors
are
pos
sibl
e w
ithin
the
one
EHR
, si
nce
the
arch
itect
ure
is g
ener
ic, a
nd d
oes n
ot c
orre
spon
d to
any
par
ticul
ar
mod
el o
r sub
dom
ain
of c
are.
How
ever
, it i
s up
to E
HR
syst
ems t
o ac
tual
ly
enab
le a
cces
s acr
oss d
iffer
ent s
ecto
rs, p
eopl
e et
c.
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
1.17
The E
HR
RA
mus
t sup
port
the r
ecor
ding
and
quer
ying
of d
ata t
o en
able
the
mea
sure
men
t of o
pera
tiona
l and
clin
ical
per
form
ance
, to
ensu
re c
ompl
i-an
ce w
ith st
anda
rds o
f car
e, to
ens
ure
qual
ity p
roce
ss a
nd to
mea
sure
out
-co
mes
.
Ther
e ar
e no
spec
ific
feat
ures
of t
he re
fere
nce
mod
els f
or
supp
ortin
g th
is. A
ny su
ch d
ata
wou
ld b
e m
odel
led
usin
g ar
chet
ypes
, and
que
ried
in th
e no
rmal
way
.
Des
ign:
TB
D
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
2.1
The
EHR
RA
mus
t sup
port
clea
r and
con
sist
ent r
ules
for e
ntry
,am
endm
ent,
verif
icat
ion,
tra
nsm
ittal
, re
ceip
t, tra
nsla
tion,
and
dele
tion
of d
ata.
Thi
s req
uire
men
t doe
s not
impl
y th
at it
is n
ec-
essa
ry fo
r a g
iven
impl
emen
tatio
n to
allo
w d
elet
ion
of E
HR
con-
tent
. Loc
al d
ata
rete
ntio
n ru
les w
ill a
pply
. (3.
3.1)
open
EHR
EH
R R
M:
all c
hang
e to
the
EHR
is g
over
ned
by th
e se
man
tics o
f ver
sion
con
trol
built
into
the VERSIONED_OBJECT
and
VERSION
cla
sses
.Th
e fa
ct o
f tra
nsm
ittal
of E
HR
ext
ract
s to
othe
r use
rs is
not
reco
rded
in
the E
HR
itse
lf, si
nce
this
is d
eem
ed to
be
the
sam
e as
any
oth
er k
ind
of n
on-m
odify
ing
acce
ss.
Whe
re re
ceip
t of E
HR
ext
ract
s or o
ther
dat
a su
ch a
s mes
sage
s cau
ses
chan
ges t
o th
e EH
R, t
he a
udit
traili
ng in
dica
tes c
lear
ly w
here
the
data
w
as a
cqui
red
from
.
Des
ign:
Par
t
ISO
Sec
tion
2.2.
2R
etrie
val/q
uery
/vie
ws
of d
ata
PRO
2.2
The
EHR
RA
mus
t sup
port
the
impl
emen
tatio
n of
rule
s for
dat
ava
lidat
ion
(3.3
.1)
Arc
hety
pes:
The
open
EHR
arc
hety
pes a
re a
key
way
of e
xpre
ssin
g co
nstra
ints
on
data
, inc
ludi
ng o
n ty
pe, v
alue
, stru
ctur
e an
d na
mes
, as w
ell a
s on
mor
e es
oter
ic th
ings
like
allo
wed
stat
e tra
nsiti
ons,
fuzz
y va
lue
map
ping
s. Th
ese
cons
train
ts p
rovi
de a
mea
ns o
f hig
h-qu
ality
dat
a va
lidat
ion.
Des
ign:
Ful
l
PRO
2.3
The
EHR
RA
mus
t sup
port
the
abili
ty to
revi
ew in
form
atio
n of
all t
ypes
reco
rded
in th
e pa
st, i
nclu
ding
via
the
use
of q
uery
and
filte
r fac
ilitie
s, du
ring
the
data
cap
ture
pro
cess
(3.3
.1)
open
EHR
EH
R R
M:
The
vers
ion
cont
rol m
echa
nism
ens
ures
that
all
prev
ious
stat
es o
f Fo
lder
s and
Tra
nsac
tions
in th
e EH
R a
re p
rese
rved
, and
ther
efor
e an
y pr
evio
us st
ate
of th
e EH
R c
an b
e re
crea
ted.
Que
ryin
g is
don
e us
ing
arch
etyp
e pa
ths w
ithin
stat
emen
ts in
a sp
ecia
l qu
ery
lang
uage
.
Des
ign:
Ful
lVa
l: C
EN, G
EHR
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
2.4
The
EHR
RA
mus
t sup
port
sele
ctiv
e re
triev
al a
nd c
usto
m-
ized
vie
ws o
f the
sam
e in
form
atio
n fo
r spe
cific
nee
ds (e
.g.
deci
sion
supp
ort,
data
ana
lysi
s) (3
.3.2
)
open
EHR
EH
R R
M:
view
s can
be
crea
ted
in v
ario
us w
ays,
incl
udin
g:•
usin
g th
e VIEW
ENTRY
typ
e, w
hich
ena
bles
the
spe
cific
atio
n an
dop
tiona
lly re
sults
of a
que
ry to
be
stor
ed in
the
EHR
;•
usin
g FOLDERs
to c
reat
e co
arse
-gra
ined
vie
ws o
f Com
posi
tions
in th
ere
cord
All
refe
renc
es in
vie
ws a
re d
efin
ed a
s EH
R P
aths
, usi
ng a
stan
dard
UR
I-lik
e te
xtua
l ref
eren
cing
mec
hani
sm fo
r any
nod
e or
leaf
in th
e EH
R.
Des
ign:
Ful
lVa
l: C
EN, S
NX
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
ISO
Sec
tion
2.2.
3Pr
esen
tatio
n of
dat
a
ISO
Sec
tion
2.2.
4Sc
alab
ility
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
2.5
The
EHR
RA
mus
t su
ppor
t th
e ab
ility
to
disp
lay
data
mar
ked
as c
linic
al s
umm
ary
with
out t
he n
eed
for m
anua
lse
arch
ing
(3.3
.3)
Clin
ical
sum
mar
ies a
re li
kely
to b
e st
ored
in o
ne o
r a sm
all n
umbe
r of p
er-
sist
ent C
ompo
sitio
ns b
ased
on
a “c
linic
al su
mm
ary”
arc
hety
pe. I
f per
sist
ent
Com
posi
tions
are
stor
ed in
thei
r ow
n FOLDER
, the
y ar
e ea
sy to
find
. A
ltern
ativ
ely,
any
Com
posi
tion
in w
hich
a c
linic
al su
mm
ary
is in
clud
ed c
an
have
an
entry
in a
n in
dex
of a
rche
type
ids-
>Tra
nsac
tions
, whe
reby
Tra
nsac
-tio
ns c
onta
inin
g an
y pa
rticu
lar k
ind
of in
form
atio
n ca
n be
qui
ckly
foun
d ba
sed
on a
rche
type
id.
Des
ign:
Ful
l
PRO
2.6
The
EHR
RA
mus
t sup
port
the
abili
ty to
con
vey
the
natu
reof
dev
ices
on
whi
ch in
form
atio
n sh
ould
by
pref
eren
ce b
epr
esen
ted
whe
re th
is m
ay a
ffec
t the
clin
ical
inte
rpre
tatio
n(e
.g. v
iew
ing
a co
lour
im
age
on a
mon
ochr
ome
view
er,
view
ing
a di
gita
l di
agno
stic
im
age
on a
low
res
olut
ion
view
er) (
3.3.
3)
open
EHR
EH
R R
M:
pres
umab
ly th
is m
eans
that
a c
linic
al in
stru
ctio
n ab
out w
hat k
ind
of d
evic
eto
vie
w th
e in
form
atio
n on
in o
rder
not
to d
imin
ish
its c
linic
al u
tility
shou
ldbe
incl
uded
in th
e obs
erva
tion.
Cur
rent
ly o
bser
vatio
n pr
otoc
ol ca
n be
reco
rd-
ed; s
houl
d a
“vie
win
g pr
otoc
ol”
also
be
incl
uded
? Th
is w
ould
seem
to a
pply
only
for v
ery
parti
cula
r circ
umst
ance
s.
Des
ign:
TB
D
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRO
2.7
The
EHR
RA
sho
uld
not i
mpe
de e
ffic
ient
pro
cess
ing
of v
ery
larg
e re
cord
s or
ver
y la
rge
num
bers
of
reco
rds.
open
EHR
EH
R R
M:
Each
EH
R c
onsi
sts o
f VERSIONED_COMPOSITIONs
who
se m
ost n
atur
al
impl
emen
tatio
n is
as s
epar
ate
entit
ies i
n a
data
base
, ens
urin
g pe
rfor
man
ce d
oes
not d
imin
ish
with
size
. Per
form
ance
of s
yste
ms c
onta
inin
g la
rge
num
bers
of
reco
rds i
s mos
tly a
syst
em is
sue,
but
is p
roba
bly
impr
oved
by
the
use
of se
para
te
Com
posi
tions
.
Des
ign:
Ful
l
ISO
Sec
tion
3C
OM
MU
NIC
ATIO
NPr
eam
ble
The
prin
cipl
e un
derly
ing
the
requ
irem
ents
in th
is s
ectio
n is
to e
nabl
e da
ta s
tore
d in
EH
Rs
to b
e tra
nsfe
rred
bet
wee
n di
ffer
ent E
HR
sys
tem
s an
d ot
her c
linic
al s
yste
ms.
Sim
ilarly
, EH
Rs m
ust b
e ab
le to
acc
ept d
ata
trans
ferr
ed fr
om d
iffer
ent E
HR
syst
ems a
nd o
ther
clin
ical
syst
ems.
Ther
e are
two
dist
inct
form
s of t
rans
fer p
ossi
ble:
mes
sagi
ng an
d re
cord
exch
ange
. Mes
sagi
ng is
nec
essa
ry w
hen
data
is tr
ansf
erre
d be
twee
n sy
stem
s whi
ch d
o no
t con
form
to th
e sa
me
EHR
arc
hite
ctur
e st
anda
rd. M
essa
ging
requ
ires
the
use
of a
gree
d pr
otoc
ols
such
as H
L7, U
N/E
DIF
AC
T an
d D
ICO
M. T
he fo
rmat
and
met
hods
of d
isse
mi-
natin
g da
ta m
ust b
e st
anda
rdis
ed w
here
ver p
ossi
ble.
Rec
ord
exch
ange
can
occ
ur w
here
dat
a is
tran
sfer
red
betw
een
two
EHR
Sys
tem
s tha
t sha
re a
com
mon
arc
hite
ctur
e. R
ecor
d ex
chan
ge in
clud
es th
e m
ovem
ent o
r cop
ying
of a
ll or
par
t of a
n EH
R.
ISO
Sec
tion
3.1
Mes
sagi
ng
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
CO
M1.
1Th
e EH
RR
A m
ust s
uppo
rt th
e ex
port
and
impo
rt of
data
rec
eive
d us
ing
mes
sagi
ng p
roto
cols
suc
h as
HL7
, UN
/ED
IFA
CT
and
DIC
OM
. (4)
Dat
a fr
om a
ny o
ther
sou
rce
can
be in
corp
orat
ed in
to th
e re
cord
and
repr
esen
ted
in n
ativ
e op
enEH
R fo
rm, a
s lon
g as
a m
appi
ng c
an b
e de
velo
ped
from
the
sour
cefo
rm to
ope
nEH
R. T
rans
form
atio
ns fr
om C
EN w
ill b
e re
lativ
ely
easy
. Im
port
ofH
L7v2
mes
sage
s has
alre
ady
been
ach
ieve
d. Im
port
of H
L7v3
has
bee
n st
udie
d,an
d sh
ould
be
poss
ible
.
Dat
a in
ano
ther
form
at w
hich
can
not b
e co
nver
ted
can
alw
ays
be re
pres
ente
d in
enca
psul
ated
form
.
Des
ign:
Par
t
ISO
Sec
tion
3.2
Rec
ord
exch
ange
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
CO
M 2
.1Th
e EH
RR
A m
ust a
llow
for
the
exch
ange
of
a co
mpl
ete
EHR
or
a pa
rt of
an
EHR
(an
ext
ract
) be
twee
n EH
RR
Aco
mpl
iant
syst
ems.
(4.4
)
The
sem
antic
s of EHR_EXTRACTs
are
form
ally
def
ined
, and
allo
w a
nysu
bset
of t
he la
test
COMPOSITIONs
of a
n EH
R to
be
trans
mitt
ed e
lse-
whe
re.
Tran
smitt
ing
a w
hole
EH
R m
eans
tran
smitt
ing
all i
ts p
revi
ous v
ersi
ons,
and
pres
umab
ly h
as th
e sem
antic
s of “
mov
ing”
rath
er th
an co
pyin
g. T
his
wou
ld b
e ac
hiev
ed b
y se
rialis
ing
the
entir
e EH
R a
ccor
ding
to th
e EH
R&
VERSIONED_COMPOSITION
cla
sses
into
an EHR_EXTRACT
and
trans
mitt
ing
it. H
owev
er, t
he p
robl
em o
f tra
nsm
ittin
g de
mog
raph
ic a
ndte
rmin
olog
y in
form
atio
n al
so h
as to
be
addr
esse
d, a
nd d
epen
ds o
n w
hat
the
inte
ntio
n is
: is
it
abou
t m
ovin
g an
ent
ire E
HR
env
ironm
ent
else
-w
here
, or j
ust o
ne p
atie
nt?
Des
ign:
Qua
lVa
l: C
EN, G
EHR
, SN
X
CO
M 2
.2Th
e EH
RR
A m
ust s
uppo
rt se
rialis
atio
n of
dat
a fo
r int
erop
-er
abili
ty p
urpo
ses
(e.g
. via
XM
L, C
OR
BA
, SO
AP,
etc
.).(4
.3)
The
open
EHR
EH
R R
M su
ppor
ts a
ny st
anda
rd se
rialis
atio
n m
echa
nism
,su
ch a
s XM
L, C
OR
BA
, .N
ET e
tc.
Des
ign:
Ful
lVa
l: C
EN, G
EHR
, SN
XC
OM
2.3
The
EHR
RA
mus
t def
ine
the
sem
antic
s of
mer
ging
dat
afr
om an
EH
R ex
tract
with
the E
HR
resi
dent
in th
e rec
eivi
ngsy
stem
. (4.
7)
open
EHR
EH
R R
M:
The VERSIONED_OBJECT
and
FEEDER_AUDIT
(re
visi
on h
isto
ry)
clas
ses a
nd a
ssoc
iate
d se
man
tics a
re p
rovi
ded
for j
ust t
his p
urpo
se.
Des
ign:
Ful
l
CO
M 2
.4Th
e EH
RR
A m
ust p
rovi
de a
n au
dit t
rail
of e
xcha
nge
proc
-es
ses,
incl
udin
g au
then
ticat
ion,
to e
nabl
e id
entif
icat
ion
ofpo
ints
of E
HR
extra
ct tr
ansm
ittal
and
rece
ipt.
This
nee
ds to
acco
unt f
or m
ergi
ng p
roce
sses
. (4.
3)
open
EHR
EH
R R
M:
this
is li
kely
to b
e in
clud
ed in
the
EHR
Ext
ract
in R
elea
se 1
.1 o
f ope
nE-
HR
.
Des
ign:
Fut
CO
M 2
.5Th
e ru
les
cove
ring
the
exch
ange
of a
n ex
tract
mus
t be
the
sam
e as
thos
e fo
r exc
hang
ing
the
com
plet
e re
cord
. (4.
4)TB
R 1:
that
dep
ends
- if
the i
nten
tion
is to
send
a co
py o
f the
curr
ent s
tate
of a
n en
tire
reco
rd fo
r clin
ical
/sha
red
care
pur
pose
s, th
is is
true
, and
an
EHR_
EXTR
ACT
can
be u
sed.
If th
e int
entio
n is
to m
ove t
he w
hole
reco
rd(e
.g. t
o an
othe
r ju
risd
ictio
n, a
noth
er in
form
atio
n gu
ardi
an),
incl
udin
gpr
evio
us v
ersi
ons,
rele
vant
dem
ogra
phic
, te
rmin
olog
ical
and
acc
ess
cont
rol d
ata,
the
sem
antic
s will
be
diffe
rent
.
Des
ign:
TB
D
CO
M 2
.6Th
e EH
RR
A m
ust e
nabl
e se
man
tic in
tero
pera
bilit
y of
clin
-ic
al c
once
pts
betw
een
EHR
sys
tem
s to
sup
port
auto
mat
icpr
oces
sing
of d
ata
at th
e re
ceiv
ing
syst
em. (
3.3.
4)
The
use
of a
rche
type
s whi
ch a
re sh
ared
by
both
EH
R sy
stem
s in
com
-m
unic
atio
n en
able
s sem
antic
inte
rope
rabi
lity
betw
een
thes
e pa
rties
.D
esig
n: F
ull
ISO
Sec
tion
4PR
IVA
CY
AN
D S
ECU
RIT
YPr
eam
ble
The
EHR
mus
t sup
port
the
ethi
cal a
nd le
gal u
se o
f per
sona
l inf
orm
atio
n, in
acc
orda
nce
with
est
ablis
hed
priv
acy
prin
cipl
es a
nd fr
amew
orks
, whi
ch m
ay b
e cu
ltura
lly o
rju
risdi
ctio
nally
spe
cific
. Key
issu
es in
clud
e co
ntro
l of a
cces
s to
the
EHR
to e
nsur
e pe
rson
al h
ealth
info
rmat
ion
can
be k
ept c
onfid
entia
l - i.
e. u
sed
only
for a
ppro
ved
purp
oses
and
shar
ed o
nly
amon
g au
thor
ised
peo
ple;
and
info
rmed
con
sent
.K
ey is
sues
in re
latio
n to
secu
rity
incl
ude
auth
entic
atio
n, d
ata
inte
grity
, con
fiden
tialit
y, n
on-r
epud
iatio
n an
d au
dita
bilit
y.
ISO
Sec
tion
4.1
Priv
acy
and
conf
iden
tialit
y
ISO
Sec
tion
4.2
Con
sent
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRS1
.1Th
e EH
RR
A m
ust s
uppo
rt th
e ap
plic
atio
n of
pre
vaili
ng p
rivac
y an
d co
n-fid
entia
lity
rule
s. (5
.2)
The EHR_ACCESS
cla
ss is
use
d as
the
glob
al in
terf
ace
to th
eEH
R an
d co
ntai
ns al
l acc
ess r
ules
from
the p
oint
of v
iew
of t
heEH
R (i
.e. s
ome
acce
ss ru
les w
ill b
e in
the
form
of s
ite-s
peci
ficpo
licie
s). A
cces
s co
ntro
l use
s EH
R p
aths
to re
fer t
o sp
ecifi
cite
ms i
n th
e ru
les.
Path
s can
be
used
to re
fer t
o an
y le
vel o
f in-
form
atio
n ite
m in
the
EHR
, fro
m a
who
le C
ompo
sitio
n to
ale
af it
em, a
lthou
gh s
ecur
ity s
ettin
g fo
r ite
ms
smal
ler
than
aC
ompo
sitio
n (o
r at w
orst
, an
Entry
) is n
ot re
com
men
ded.
The
deta
iled
mod
el o
f sec
urity
will
app
ear i
n R
elea
se 1
.2.
Des
ign:
Par
t
PRS1
.2Th
e EH
RR
A m
ust s
uppo
rt th
e la
belli
ng o
f the
who
le a
nd/o
r sec
tions
of
the E
HR
as re
stric
ted
to au
thor
ised
use
rs an
d/or
pur
pose
s. Th
is sh
ould
in-
clud
e re
stric
tions
at t
he le
vel o
f rea
ding
, writ
ing,
am
endm
ent,
verif
ica-
tion,
and
tran
smis
sion
/dis
clos
ure
of d
ata
and
reco
rds (
5.2)
PRS1
.3Th
e EH
RR
A m
ust s
uppo
rt pr
ivac
y an
d co
nfid
entia
lity
rest
rictio
ns a
t the
leve
l of b
oth
data
sets
and
dis
cret
e da
ta a
ttrib
utes
.
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRS2
.1Th
e EH
RR
A m
ust s
uppo
rt re
cord
ing
of in
form
ed c
onse
nt fo
r the
cre
atio
nof
a re
cord
. (5.
3)It
appe
ars t
hat t
he c
onse
nt d
ata
in a
ll of
thes
e re
quire
men
tsca
n be
adeq
uate
ly ca
ptur
ed in
a co
mbi
natio
n of
INSTRUC-
TION
and
OBSERVATION
ENTRY
typ
es;
an a
ltern
ativ
ew
ill b
e to
trea
t it a
s an ADMIN_ENTRY
. Eith
er w
ay, a
rche
-ty
pes
have
to b
e de
velo
ped
for t
his
purp
ose.
Thi
s re
quire
sfu
rther
clin
ical
exp
erie
nce.
Des
ign:
Qua
l
PRS2
.2Th
e EH
RR
A m
ust s
uppo
rt ob
tain
ing,
reco
rdin
g an
d tra
ckin
g th
e st
atus
of
info
rmed
con
sent
to a
cces
s th
e w
hole
and
/or s
ectio
ns o
f the
EH
R, f
or d
e-fin
ed p
urpo
ses.
(5.3
)PR
S2.3
The
EHR
RA
mus
t sup
port
reco
rdin
g of
the
purp
oses
for w
hich
con
sent
isob
tain
ed. (
5.3)
PRS2
.4Th
e EH
RR
A m
ust s
uppo
rt re
cord
ing
of th
e tim
e fr
ames
atta
ched
to e
ach
cons
ent.
(5.3
)
ISO
Sec
tion
4.3
Acc
ess
cont
rol
ISO
Sec
tion
4.4
Dat
a in
tegr
ity
ISO
Sec
tion
4.5
Aud
itabi
lity
of a
cces
s
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRS3
.1Th
e EH
RR
A m
ust s
uppo
rt m
easu
res
to d
efin
e, a
ttach
,m
odify
and
rem
ove
acce
ss r
ight
s to
the
who
le a
nd/o
rse
ctio
ns o
f the
EH
R. (
5.1.
1)
open
EHR
EH
R R
M:
Acc
ess c
ontro
l set
tings
can
be
atta
ched
to a
ny a
rche
type
d st
ruct
ure,
incl
udin
g th
e EHR
, a VERSIONED_COMPOSITION
, an SECTION
and
an ENTRY.
The
ac
cess
con
trol s
ettin
gs a
re d
efin
ed o
utsi
de th
e EH
R a
rchi
tect
ure.
The
se m
ay
be c
hang
ed a
t any
tim
e.
Des
ign:
Ful
l
PRS3
.2Th
e EH
RR
A m
ust s
uppo
rt m
easu
res
to d
efin
e, a
ttach
,m
odify
and
rem
ove
acce
ss ri
ghts
for c
lass
es o
f use
rs o
fth
e EH
R. (
5.1.
1)
The
open
EHR
arc
hite
ctur
e do
es n
ot d
efin
e an
y pa
rticu
lar m
odel
of a
cces
s co
ntro
l, it
just
pro
vide
s pla
ces t
o pu
t acc
ess c
ontro
l set
tings
at t
he lo
wes
t m
eani
ngfu
l lev
el o
f gra
nula
rity,
i.e.
arc
hety
ped
stru
ctur
es.
Des
ign:
Qua
l
PRS3
.3Th
e EH
RR
A m
ust s
uppo
rt m
easu
res
to e
nabl
e an
d re
-st
rict a
cces
s to
the
who
le a
nd/o
r sec
tions
of t
he E
HR
inac
cord
ance
with
pre
vaili
ng c
onse
nt a
nd a
cces
s ru
les.
(5.1
.1)
The
deta
ils o
f how
con
sent
and
acc
ess c
ontro
l are
repr
esen
ted
are
not y
et
com
plet
ed in
the
open
EHR
EH
R R
M.
Des
ign:
TB
D
PRS3
.4Th
e EH
RR
A m
ust s
uppo
rt m
easu
res
to s
epar
atel
y co
n-tro
l aut
horit
ies
to a
dd to
and
/or
mod
ify th
e EH
R f
rom
auth
oriti
es to
acc
ess t
he E
HR
(5.1
.1)
open
EHR
EH
R R
M:
The
deta
iled
secu
rity
mod
el (
clas
s EHR_ACCESS_SETTINGS
) w
ill b
e de
-fin
ed in
Rel
ease
1.2
.
Des
ign:
Fut
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRS4
.1Th
e EH
RR
A m
ust s
uppo
rt m
easu
res
to e
nsur
e th
ein
tegr
ity o
f da
ta s
tore
d in
and
tra
nsfe
rred
to
and
from
EH
Rs (
2.8.
3)
The VERSION
cla
ss in
clud
es a
dig
ital s
igna
ture
attr
ibut
e th
at m
ay b
e us
ed to
hol
d a
hash
and
/or d
igita
l sig
natu
re, w
hich
con
form
s to
the
open
PGP
stan
dard
.D
esig
n: F
ull
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
PRS5
.1Th
e EH
RR
A m
ust s
uppo
rt re
cord
ing
of a
n au
dit t
rail
of a
c-ce
ss to
and
mod
ifica
tions
of d
ata w
ithin
the w
hole
or s
ectio
nsof
the
EHR
. (5.
5)
open
EHR
EH
R R
M:
Mod
ifica
tions
are
aud
it tra
iled
in th
e AUDIT_DETAILS
of e
ach COM-
POSITION
. Atte
stat
ions
for p
artic
ular
cha
nged
item
s can
be
incl
uded
as
requ
ired.
Des
ign:
Ful
l
PRS5
.2Th
e EH
RR
A m
ust s
uppo
rt re
cord
ing
of th
e nat
ure o
f eac
h ac
-ce
ss a
nd/o
r tra
nsac
tion.
(5.5
)op
enEH
R E
HR
RM
:A
ll m
odifi
catio
ns a
re a
udit-
traile
d in
the AUDIT_DETAILS
obj
ect o
f a
COMPOSITION
. Acc
ess l
ogs a
re n
ot d
efin
ed sp
ecifi
cally
in o
penE
HR
.D
esig
n: F
ull/F
ut
PRS5
.3Th
e EH
RR
A m
ust s
uppo
rt au
dit c
apab
ility
suff
icie
nt to
trac
kac
coun
tabi
lity
for e
ach
step
or t
ask
in th
e cl
inic
al o
r ope
ra-
tiona
l pro
cess
es re
cord
ed in
the
reco
rd. (
5.5)
open
EHR
EH
R R
M:
Each
dis
tinct
clin
ical
obs
erva
tion,
eva
luat
ion
or a
naly
sis,
and
actio
n re
cord
ed is
repr
esen
ted
usin
g an
ENTRY,
whi
ch e
nsur
es th
e re
leva
nt c
on-
text
info
rmat
ion
for e
ach
such
act
ion
is re
cord
ed.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
ISO
Sec
tion
5M
EDIC
O-L
EGA
LPr
eam
ble
Req
uire
men
ts fo
r the
med
ico-
lega
l asp
ects
of t
he E
HR
RA
are
ess
entia
l if E
HR
s are
to b
e tru
sted
by
both
con
sum
ers a
nd c
linic
ians
and
acc
epte
d in
cou
rts o
f law
as e
vi-
denc
e of
car
e pr
ovid
ed, c
ompl
ianc
e w
ith le
gisl
atio
n, a
nd th
e co
mpe
tenc
e of
clin
icia
ns. M
any
of th
e m
edic
o-le
gal r
equi
rem
ents
are
rela
ted
to a
nd h
ave
impl
icat
ions
for
both
priv
acy
and
secu
rity
of th
e EH
R b
ut a
re n
ever
thel
ess a
dis
tinct
cat
egor
y.Fo
r med
ico-
lega
l pur
pose
s it
is e
ssen
tial t
hat e
very
add
ition
, am
endm
ent o
r alte
ratio
n to
the
EHR
be
perm
anen
tly re
cord
ed a
nd p
rese
rved
for a
n in
defin
ite p
erio
d. T
om
aint
ain
its o
rigin
ality
, inf
orm
atio
n m
ust n
ot b
e su
bjec
t to
late
r alte
ratio
n or
era
sure
. It i
s al
so e
ssen
tial t
hat e
very
act
or b
e un
ambi
guou
sly
iden
tifie
d an
d in
extri
cabl
ylin
ked
to th
e in
form
atio
n fo
r whi
ch th
ey a
ttest
.Le
gal r
equi
rem
ents
will
var
y w
idel
y am
ong
juris
dict
ions
. In
reco
gnis
ing
thes
e var
ianc
es th
e EH
R m
ust n
ot at
tem
pt to
impo
se le
gal o
blig
atio
ns o
f one
soci
ety
upon
anot
her.
The
EHR
RA
shou
ld e
nsur
e th
at th
e EH
R c
an b
e a
lega
lly a
ccep
tabl
e do
cum
ent i
n th
e ju
risdi
ctio
n in
whi
ch it
is c
reat
ed.
ISO
Sec
tion
5.1
Supp
ort f
or le
gal r
equi
rem
ents
ISO
Sec
tion
5.2
Act
ors
ISO
Sec
tion
5.2.
1Su
bjec
t of h
ealth
care
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
1.1
The
EHR
RA
mus
t sup
port
mea
sure
s to
ens
ure
an a
ccur
ate
refle
c-tio
n of
the
chro
nolo
gy o
f clin
ical
eve
nts a
nd in
form
atio
n av
aila
bil-
ity in
the
EHR
(6.3
)
open
EHR
EH
R R
M:
the
mod
el sp
ecifi
cally
dis
tingu
ishe
s bet
wee
n da
te/ti
mes
of c
linic
al
even
ts a
nd a
cts,
and
inte
ract
ions
with
the
EHR
syst
em, e
nsur
ing
that
the
chro
nolo
gy o
f eve
nts i
n th
e re
al w
orld
is c
lear
, as w
ell a
s th
e ch
rono
logy
of c
hang
es to
the
EHR
.
Des
ign:
Ful
l
MEL
1.2
The
EHR
RA
mus
t ena
ble
the
view
ing
of a
n ac
cura
te re
pres
enta
tion
of th
e EH
R a
t any
par
ticul
ar d
ate
and
time
sinc
e its
cre
atio
n (6
.4)
open
EHR
EH
R R
M:
the
mod
el e
xplic
itly
incl
udes
ver
sion
ing
sem
antic
s in
the
VERSIONED_COMPOSITION
and
rela
ted
clas
ses.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
2.1
The
EHR
RA
mus
t cat
er f
or th
e su
bjec
t of
care
of
the
EHR
to b
e on
e or
mor
e pe
rson
s (6.
1.1)
Cur
rent
ly a
ny si
tuat
ion
in w
hich
hea
lth in
form
atio
n fo
r a s
ubje
ct o
ther
than
the
subj
ect o
f the
reco
rd, e
.g. a
fam
ily m
embe
r, a
dona
ted
orga
n, o
r a fo
etus
is w
ell-
unde
rsto
od a
nd c
ater
ed fo
r via
the
subj
ect a
ttrib
ute
in ENTRY
.
Req
uire
men
ts fo
r fam
ilies
, trib
es, o
r oth
er so
cial
gro
upin
gs h
ave
not b
een
wid
e-ly
des
crib
ed o
r an
alys
ed, b
ut in
any
cas
e ca
n be
acc
omm
odat
ed b
y th
e sa
me
mec
hani
sm, l
imite
d on
ly b
y w
hat d
emog
raph
ic e
ntiti
es c
an b
e re
pres
ente
d.
Des
ign:
Ful
l
ISO
Sec
tion
5.2.
2Pa
tient
iden
tific
atio
n
ISO
Sec
tion
5.2.
3U
ser I
dent
ifica
tion
ISO
Sec
tion
5.2.
4H
ealth
care
par
ties
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
2.2
The
EHR
RA
mus
t cat
er fo
r the
reco
rdin
g of
app
ropr
iate
pat
ient
iden
tific
atio
n at
tribu
tes
and
clin
ical
ly re
leva
nt p
atie
nt a
ttrib
utes
such
as d
ate
of b
irth,
sex,
eth
nici
ty e
tc. (
6.1.
2)
open
EHR
Dem
ogra
phic
RM
:al
l PERSONs
, inc
lude
pat
ient
s can
hav
e an
y nu
mbe
r of i
dent
ifier
s and
othe
r dat
a re
cord
ed fo
r the
m.
Des
ign:
Ful
lVa
l: C
EN,
GEH
R, S
NX
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
2.3
The
EHR
RA
mus
t ens
ure
that
use
rs w
ho a
ttest
and
com
mit
any
parti
cula
r inf
orm
atio
n to
the
reco
rd a
reun
ique
ly a
nd re
liabl
y id
entif
ied
(6.1
.3)
The
EHR
gua
rant
ees t
hat d
istin
ct id
entif
iers
whi
ch o
ccur
in th
e EH
R c
orre
spon
d to
dis
tinct
dem
ogra
phic
ent
ities
, i.e
. tha
t ide
ntifi
ers a
re n
ot re
-use
d. T
he ATTES-
TATION
type
exp
licitl
y in
dica
tes t
he c
omm
itter
of t
he a
ttest
atio
n.
Des
ign:
Ful
lVa
l: G
EHR
, SN
X
MEL
2.4
The
EHR
RA
mus
t su
ppor
t th
e on
-goi
ng a
bilit
y to
iden
tify
user
s, ev
en if
they
cha
nge
thei
r na
me,
pro
-fe
ssio
n, se
x, o
r add
ress
. (6.
1.3)
open
EHR
EH
R R
M:
iden
tifie
rs in
the E
HR
refe
rrin
g to
dem
ogra
phic
entit
ies m
anag
ed in
a d
emog
raph
-ic
serv
ice
alw
ays r
efer
to th
e cu
rren
t inf
orm
atio
n in
that
serv
ice.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
2.5
The E
HR
RA
mus
t sup
port
mea
sure
s to
ensu
reth
at a
ll cl
inic
al p
artie
s ref
erre
d to
in th
e EH
Rar
e un
ique
ly id
entif
ied
(6.1
.4)
open
EHR
EH
R R
M:
All
dem
ogra
phic
ent
ities
are
refe
rred
to u
sing
PARTY_IDENTIFIED
and
PARTY_NAMED
obj
ects
.
Des
ign:
Ful
l
MEL
2.6
The
EHR
RA
mus
t su
ppor
t th
e re
cord
ing
ofth
e cl
inic
al ro
les o
f any
par
ties w
ith re
spec
t to
any
clin
ical
act
ivity
reco
rded
. (6.
1.4)
open
EHR
EH
R R
M:
Cur
rent
ly ro
les a
nd o
ther
dem
ogra
phic
det
ails
are
def
ined
in th
e de
mog
raph
ic m
odel
an
d its
arc
hety
pes.
Rol
es a
nd re
latio
nshi
ps a
re in
clud
ed in
the
EHR
arc
hite
ctur
e in
the
form
of t
he PARTICIPATION
and
var
ious
PARTY_PROXY
type
s.
Des
ign:
Ful
l
ISO
Sec
tion
5.2.
5A
utho
r res
pons
ibili
ty
ISO
Sec
tion
5.2.
6A
ttest
atio
n/A
utho
rizat
ion
of e
ntrie
s
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
2.7
The
EHR
RA
mus
t sup
port
mea
sure
s w
hich
ens
ure
that
ever
y re
cord
ent
ry is
dat
ed, i
ts a
utho
r ide
ntifi
ed. (
6.1.
6)op
enEH
R E
HR
RM
:al
l add
ition
s to
the
reco
rd a
re in
the
form
of COMPOSITIONs
, whi
ch in
dica
te
the
auth
or’s
iden
tity,
dat
e.tim
e of
add
ition
.
Des
ign:
Ful
l
MEL
2.8
The
EHR
RA
mus
t sup
port
mea
sure
s to
ensu
re th
at th
ere
is a
n ab
solu
te re
quire
men
t tha
t eac
h co
ntrib
utio
n to
the
reco
rd i
s at
tribu
ted
to a
res
pons
ible
hea
lthca
re p
arty
whe
ther
in th
e ro
le o
f aut
hor o
r not
. (6.
1.5)
open
EHR
EH
R R
M:
each
COMPOSITION
in th
e re
cord
iden
tifie
s, vi
a its
sub-
obje
cts:
•pa
rtici
patio
ns,
e.g.
in
clud
ing
HC
A
lega
lly
resp
onsi
ble
(EVENT_CONTEXT
)•
com
mitt
er (AUDIT_DETAILS
)•
info
rmat
ion_
prov
ider
(ENTRY
)
Des
ign:
Ful
lVa
l: G
EHR
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
2.9
The
EHR
RA
mus
t su
ppor
t m
easu
res
whi
ch e
nsur
e th
at e
very
cont
ribut
ion
to th
e re
cord
mus
t be
atte
sted
by
a re
spon
sibl
e pe
r-so
n . (
6.1.
6)
open
EHR
EH
R R
M:
ever
y COMPOSITION
incl
udes
a AUDIT_DETAILS
obj
ect w
hich
co
ntai
ns th
e m
anda
tory
attr
ibut
e co
mm
itter
:PARTY_REF.
An
atte
s-ta
tion
form
of t
he AUDIT_DETAILS
obj
ect c
an b
e us
ed if
des
ired,
al
low
ing
digi
tal s
igni
ng.
Des
ign:
Ful
lVa
l: C
EN, G
EHR
, SN
X
MEL
2.10
The
EHR
RA
mus
t sup
port
mea
sure
s w
hich
ens
ure
that
am
end-
men
ts ar
e attr
ibut
ed to
a re
spon
sibl
e per
son
and
the d
ate a
nd ti
me
and
the
reas
on fo
r the
am
endm
ent a
re re
cord
ed. (
6.6)
open
EHR
EH
R R
M:
amen
dmen
ts an
d ne
w in
form
atio
n ar
e don
e by
the
sam
e mec
hani
sm,
nam
ely COMPOSITIONs
, whi
ch a
lway
s inc
lude
thes
e de
tails
..
Des
ign:
Ful
lVa
l: C
EN, G
EHR
, SN
X
ISO
Sec
tion
5.3
Clin
ical
com
pete
nce/
gove
rnan
ce
ISO
Sec
tion
5.4
Faith
fuln
ess
ISO
Sec
tion
5.5
Pres
erva
tion
of c
onte
xt
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
3.1
The
EHR
RA
mus
t sup
port
the
dem
onst
ratio
nof
clin
ical
com
pete
nce
and
acco
unta
bilit
y of
clin
icia
ns (6
.2)
The
open
EHR
app
roac
h en
sure
s th
at a
ny a
dditi
on th
at c
linic
ians
mak
e to
the
reco
rdid
entif
ies t
he a
utho
r, th
e co
ntex
t of c
are
and
of re
cord
ing,
and
allo
ws r
easo
ns fo
r doi
ngth
ings
to b
e re
cord
ed (e
.g. i
dent
ifyin
g gu
idel
ines
etc
.). L
inks
use
d to
repr
esen
t cau
sal
and
othe
r rel
atio
nshi
ps e
nabl
e ch
ains
of e
vent
s to
be
follo
wed
bac
k in
tim
e, e
nsur
ing
that
, as
long
as
all a
ctio
ns a
re re
cord
ed in
the
reco
rd, t
he re
cord
will
sup
port
the
clin
i-ci
ans’
cla
ims t
o ha
ve p
erfo
rmed
thos
e ac
tions
. The
abi
lity
to re
crea
te a
ny p
rior s
tate
of
the
reco
rd g
uara
ntee
s th
at a
ny c
linic
ian’
s cl
aim
abo
ut w
hat i
nfor
mat
ion
was
ava
ilabl
eca
n be
supp
orte
d.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
4.1
The
EHR
RA
mus
t ens
ure
that
info
rmat
ion
inte
nded
to s
uper
sede
that
al-
read
y re
cord
ed a
nd a
ttest
ed m
ust b
e se
para
tely
col
lect
ed a
nd a
ttest
ed a
s ane
w tr
ansa
ctio
n ve
rsio
n. (6
.5.1
)
ope
nEH
R E
HR
RM
:th
is is
exa
ctly
the
way
the
open
EHR
COMPOSITION
con
cept
wor
ks.
Des
ign:
Ful
lVa
l: G
EHR
MEL
4.2
The
EHR
RA
mus
t ens
ure
that
the
exac
t sta
te o
f the
reco
rd c
an b
e re
-cre
-at
ed fo
r any
giv
en p
oint
of t
ime
sinc
e th
e or
igin
al c
reat
ion
of th
e EH
R.
ope
nEH
R E
HR
RM
:th
is is
ena
bled
by
the
vers
ioni
ng m
echa
nism
.D
esig
n: F
ull
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
5.1
Whe
re c
oded
term
s in
the
EHR
hav
e be
en m
appe
d to
ano
ther
cod
ed te
r-m
inol
ogy,
the
EHR
RA
mus
t pro
vide
a m
eans
of i
ndic
atin
g th
e fa
ithfu
l-ne
ss o
f the
tran
slat
ion
(6.5
.2).
The
open
EHR
Dat
a Ty
pes R
M:
map
ping
s be
twee
n an
y te
xt it
em (c
oded
or n
ot) a
nd a
cod
edte
rm a
re e
xplic
itly
mod
elle
d by
the TERM_MAPPING
cla
ss.
The
mat
ch a
ttrib
ute
indi
cate
s th
e cl
osen
ess
of t
he m
atch
(bro
ader
, nar
row
er, e
quiv
alen
t).
Des
ign:
Ful
l
MEL
5.2
The
EHR
RA
mus
t mai
ntai
n th
e or
igin
al c
onte
xt o
f al
l ele
men
ts o
f th
ere
cord
irr
espe
ctiv
e of
the
pot
entia
l se
para
te d
istri
butio
n of
ele
men
ts(6
.5.2
)
The o
penE
HR
EH
R m
odel
is b
ased
on
a the
ory
of c
onte
xt [2
]w
hich
ens
ures
that
this
exa
ct re
quire
men
t is a
lway
s met
.D
esig
n: F
ull
ISO
Sec
tion
5.6
Perm
anen
ce
ISO
Sec
tion
5.7
Vers
ion
cont
rol
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
6.1
The
EHR
RA
mus
t en
sure
tha
t at
test
ed i
nfor
mat
ion
shal
l be
stor
ed i
n a
prot
ecte
d m
ode,
dis
allo
win
g an
y ch
ange
s or
del
e-tio
ns. (
6.6)
open
EHR
EH
R R
M:
The VERSIONED_COMPOSITION
cla
ss p
erfo
rms t
his f
unct
ion.
Des
ign:
Ful
lVa
l: G
EHR
MEL
6.2
The
EHR
RA
will
ens
ure
that
am
endm
ents
are
attr
ibut
ed to
a c
li-ni
cian
and
the
date
and
tim
e, a
nd th
e re
ason
for t
he a
men
dmen
tar
e re
cord
ed. (
6.6)
open
EHR
EH
R R
M:
The A
UDIT_DETAILS
clas
s rec
ords
the c
linic
ian
auth
oris
ing
com
mit-
tal,
and
date
/tim
e of
com
mitt
al, a
mon
g ot
her t
hing
s.
Des
ign:
Ful
lVa
l: G
EHR
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
MEL
7.1
The
EHR
RA
mus
t inc
orpo
rate
a m
etho
d of
ver
sion
con
trol t
hat
supp
orts
info
rmat
ion
at th
e le
vel a
t whi
ch it
was
atte
sted
(6.8
)op
enEH
R E
HR
RM
:Th
e VERSIONED_COMPOSITION
cla
ss p
erfo
rms t
his f
unct
ion.
Des
ign:
Ful
lVa
l: G
EHR
MEL
7.2
The
EHR
RA
mus
t sup
port
mea
sure
s to
dis
cern
mod
ifica
tion
orup
datin
g of
the
reco
rd u
sing
ver
sion
con
trol (
6.8)
open
EHR
EH
R R
M:
The VERSIONED_COMPOSITION
cla
ss p
erfo
rms t
his f
unct
ion.
Des
ign:
Ful
lVa
l: G
EHR
ISO
Sec
tion
6ET
HIC
AL
Prea
mbl
eTh
e et
hica
l and
mor
al ju
stifi
catio
n fo
r the
cre
atio
n, st
orag
e an
d pr
oces
sing
of h
ealth
reco
rds d
eriv
es fr
om th
e fa
ct th
at th
ey a
re in
stru
men
tal f
or th
e pr
otec
tion
of h
ealth
.Th
e fo
unda
tions
of t
he re
latio
nshi
p be
twee
n a
clin
icia
n an
d a
patie
nt a
re th
e de
liver
y of
clin
ical
car
e to
the
high
est s
tand
ard
and
the
resp
ect f
or p
atie
nt a
uton
omy.
Thi
sin
evita
bly
lead
s to
the
conc
lusi
on th
at th
e rig
ht to
info
rmed
con
sent
and
the
right
to c
onfid
entia
lity
are
also
eth
ical
/mor
al p
rinci
ples
of t
he h
ighe
st im
porta
nce.
ISO
Sec
tion
6.1
Supp
ort f
or e
thic
al ju
stifi
catio
n
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
ETH
1.1
The E
HR
RA
mus
t be a
ble t
o re
cord
ethi
cal a
ppro
val
for s
econ
dary
use
s of p
atie
nt in
form
atio
n he
ld in
the
EHR
(8)
No
spec
ific
faci
lity
has b
een
incl
uded
for t
his p
urpo
se. I
t is e
xpec
ted
that
furth
er re
-se
arch
and
dev
elop
men
t exp
erie
nce
is re
quire
d be
fore
this
requ
irem
ent c
an b
e an
a-ly
sed
wel
l eno
ugh
to b
e im
plem
ente
d. T
his m
ay b
ecom
e pa
rt of
the
acce
ss ru
les i
nth
e EHR_ACCESS
obj
ect.
Des
ign:
TB
D
ISO
Sec
tion
7C
ON
SUM
ER/ C
ULT
UR
AL
ISO
Sec
tion
7.1
Con
sum
er is
sues
Prea
mbl
eB
enef
its o
f EH
Rs f
or c
onsu
mer
sEH
Rs
have
the
pote
ntia
l to
sign
ifica
ntly
impr
ove
qual
ity o
f car
e an
d he
alth
out
com
es fo
r con
sum
ers,
prim
arily
thro
ugh
avai
labi
lity
to c
linic
ians
of a
ccur
ate,
cur
rent
in-
form
atio
n ab
out a
con
sum
er's
heal
thca
re h
isto
ry. I
mpr
oved
acc
ess t
o in
form
atio
n fo
r bot
h co
nsum
ers a
nd c
linic
ians
has
the
pote
ntia
l to
impr
ove
com
mun
icat
ion
betw
een
cons
umer
s an
d cl
inic
ians
, res
ultin
g in
mor
e m
eani
ngfu
l con
sum
er p
artic
ipat
ion
in th
e he
alth
care
pro
cess
. Hav
ing
acce
ss to
suc
h in
form
atio
n is
em
pow
erin
g, e
nabl
ing
peop
le to
inte
ract
as i
nfor
med
con
sum
ers a
nd m
ake
sens
ible
cho
ices
with
in th
e he
alth
care
syst
em.
Acc
omm
odat
ing
the
need
s and
inte
rest
of c
onsu
mer
s rai
ses i
ssue
s of p
rivac
y, se
curit
y, c
onfid
entia
lity
and
acce
ss.
Con
sum
er a
spec
ts o
f pri
vacy
, sec
urity
and
con
fiden
tialit
yC
onsu
mer
s of
hea
lthca
re s
ervi
ces
mus
t be
secu
re in
the
know
ledg
e th
at th
e in
form
atio
n th
ey s
hare
with
thei
r clin
icia
n is
trea
ted
with
resp
ect f
or th
eir p
rivac
y an
d ke
ptse
cure
and
con
fiden
tial.
Oth
erw
ise,
they
will
be
unw
illin
g to
seek
app
ropr
iate
car
e or
to p
rovi
de a
ccur
ate
and
com
plet
e in
form
atio
n. T
his w
ill n
ot o
nly
com
prom
ise
thei
row
n he
alth
care
, but
will
als
o co
nfou
nd p
rogr
amm
es o
f clin
ical
and
hea
lth se
rvic
es re
sear
ch, h
ealth
pro
fess
iona
l edu
catio
n an
d pu
blic
hea
lth p
rom
otio
n.C
onsu
mer
s' p
oint
of v
iew
EHR
s will
not
onl
y be
acc
essi
ble
to c
onsu
mer
s but
als
o in
corp
orat
e th
eir v
iew
s and
com
men
ts re
sulti
ng fr
om se
lf-m
onito
ring
of il
lnes
s, di
etar
y no
tes,
note
s on
self-
mon
-ito
ring
of sp
ort a
nd e
xerc
ise
perf
orm
ance
, beh
avio
ural
act
iviti
es a
nd m
oods
, etc
. Con
sum
ers m
ay a
lso
use
EHR
s to
seek
adv
ice
abou
t im
prov
ing
thei
r hea
lth o
r ask
que
s-tio
ns a
bout
the
man
agem
ent o
f the
ir ca
re. A
con
sum
er's
poin
t of v
iew
is im
porta
nt, s
uppo
rting
con
sum
er in
volv
emen
t and
pro
mot
ing
com
mun
icat
ion
betw
een
cons
umer
san
d cl
inic
ians
.C
ultu
ral i
ssue
sC
ultu
ral i
ssue
s are
an es
sent
ial c
ateg
ory
of in
form
atio
n to
be r
ecog
nise
d an
d ac
com
mod
ated
in th
e req
uire
men
ts fo
r EH
Rs.
Man
y cu
lture
s do
not s
uppo
rt th
e ide
a of s
harin
gpa
tient
info
rmat
ion.
Oth
ers s
hare
info
rmat
ion
and
deci
sion
mak
ing
on h
ealth
mat
ters
at t
he le
vel o
f the
ext
ende
d fa
mily
or l
arge
r gro
up.
Som
e co
mpo
nent
s of
clin
ical
com
pete
nce
are
clos
ely
rela
ted
to th
e ro
le o
f clin
icia
ns in
the
soci
etie
s in
whi
ch th
ey p
ract
ice.
The
EH
RR
A m
ust n
ot im
pose
the
clin
ical
prac
tice
of o
ne so
ciet
y on
the
clin
ical
pra
ctic
e of
ano
ther
, alth
ough
it sh
ould
pro
mot
e w
ays o
f lea
rnin
g ab
out d
iffer
ent s
tyle
s of c
linic
al p
ract
ice.
EH
R d
evel
opm
ent,
ther
efor
e, n
eeds
to fo
cus
on c
omm
unity
issu
es in
volv
ing
cultu
re a
nd c
onse
nt, e
xpec
tatio
ns, l
angu
age,
relig
ious
bel
iefs
, ind
ivid
ual i
dent
ifica
tion
and
all t
hese
will
det
erm
ine
the
subs
eque
nt h
ealth
care
mod
el.
ISO
Sec
tion
7.1.
1Su
ppor
t for
con
sum
er is
sues
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
CO
C1.
1Th
e EH
RR
A m
ust s
uppo
rt th
e pr
oduc
tion
of a
con
sum
eror
ient
ed v
iew
. (9.
1)op
enEH
R E
HR
RM
:Si
nce
all c
ontri
butio
ns to
the
reco
rd a
re m
arke
d w
ith th
e au
thor
’s id
entif
ica-
tion,
a v
iew
of p
atie
nt-a
dded
dat
a ar
e ea
sily
pos
sibl
e.
If s
impl
ifica
tion
of d
ata
& p
rese
ntat
ion
is re
quire
d, e
ither
softw
are
appl
ica-
tions
or
parti
cula
r co
nsum
er-o
rient
ed a
rche
type
s w
ould
hav
e to
be
deve
l-op
ed.
Des
ign:
Qua
l
ISO
Sec
tion
7.2
Cul
tura
l iss
ues
ISO
Sec
tion
7.2.
1Su
ppor
t for
cul
tura
l iss
ues
CO
C1.
2Th
e EH
RR
A m
ust s
uppo
rt co
nsum
ers'
right
of a
cces
s to
all
EHR
info
rmat
ion
subj
ect t
o ju
risdi
ctio
nal c
onst
rain
ts. (
9.1)
The
open
EHR
mod
els
do n
ot p
rede
term
ine
any
parti
cula
r mod
el o
f acc
ess;
they
supp
ort w
hich
ever
acce
ss co
ntro
l mod
el is
requ
ired
to b
e use
d in
a gi
ven
usag
e sc
ope.
Des
ign:
Qua
l
CO
C1.
4Th
e EH
RR
A m
ust s
uppo
rt co
nsum
ers b
eing
abl
e to
inco
r-po
rate
self-
care
info
rmat
ion,
thei
r poi
nt o
f vie
w o
n pe
rson
-al
hea
lthca
re is
sues
, lev
els o
f sat
isfa
ctio
n, ex
pect
atio
ns an
dco
mm
ents
they
wis
h to
reco
rd in
EH
Rs.
(9.1
)
open
EHR
EH
R R
M:
Self-
care
info
rmat
ion
is a
dded
in th
e sa
me
way
as a
ny in
form
atio
n is
add
edby
a c
linic
ian.
Pers
onal
com
men
ts, e
xpec
tatio
ns e
tc. c
an b
e ad
ded
acco
rdin
g to
con
sum
er-
orie
nted
arc
hety
pes w
hich
are
dev
elop
ed fo
r thi
s pur
pose
.
Des
ign:
Qua
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
CO
C2.
1Th
e EH
RR
A m
ust s
uppo
rt in
tero
pera
bilit
y in
aw
ay th
at is
trul
y gl
obal
, yet
resp
ects
loca
l cus
-to
ms
and
cultu
re.
It fo
llow
s th
at t
he p
roce
ssm
ust b
e bo
th s
impl
e an
d am
enab
le to
cus
tom
i-sa
tion
in d
iffer
ent j
uris
dict
ions
. (9.
2)
Gen
eral
supp
ort f
or in
tero
pera
bilit
y oc
curs
with
the
appr
oach
of u
sing
a g
ener
ic m
odel
whi
ch d
oes n
ot d
escr
ibe
any
spec
ific
clin
ical
or m
edic
al c
once
pts.
open
EHR
Dat
a Ty
pes:
Dat
a in
tero
pera
bilit
y is
supp
orte
d as
follo
ws:
•al
l cod
ed te
rms i
nclu
de te
rmin
olog
y id
entif
ier
•al
l tex
t typ
es u
se U
NIC
OD
E
open
EHR
EH
R R
M:
Oth
er a
spec
ts o
f int
erop
erab
ility
:•
the
stru
ctur
e of
the
reco
rd is
ess
entia
lly c
onta
iner
/hea
ding
s/st
ruct
ured
dat
a, a
ndda
ta m
ay b
e as
min
imal
ly o
r max
imal
ly st
ruct
ured
as d
esire
d.
open
EHR
Arc
hety
pe sy
stem
s:Th
e ar
chet
ype
syst
em p
rovi
des
the
mos
t pow
erfu
l bas
is fo
r sem
antic
inte
rope
rabi
lity,
whi
le a
llow
ing
loca
l def
initi
on a
nd c
usto
mis
atio
n of
arc
hety
pes
acco
rdin
g to
requ
ired
med
ical
and
soci
al c
ultu
res.
Des
ign:
Ful
l
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
ISO
Sec
tion
8EV
OLU
TIO
NPr
eam
ble
To e
nabl
e th
e cr
eatio
n an
d m
aint
enan
ce o
f life
-tim
e lo
ngitu
dina
l ele
ctro
nic
heal
th re
cord
s, it
is n
eces
sary
to e
nsur
e th
at b
oth
EHR
s and
EH
R so
ftwar
e ar
e "f
utur
e pr
oof"
.Te
chno
logy
will
con
tinue
to c
hang
e ra
pidl
y. T
his
mea
ns th
at th
e EH
RR
A m
ust b
e ef
fect
ivel
y te
chno
logy
inde
pend
ent.
The
EHR
arc
hite
ctur
e m
ust t
here
fore
be
able
toac
com
mod
ate
new
form
s of c
linic
al k
now
ledg
e (e
.g. g
enom
ics a
nd p
rote
omic
s) w
hich
may
incl
ude
not o
nly
new
clin
ical
con
tent
but
als
o co
mpl
etel
y ne
w ty
pes o
f dat
a.O
n th
e ot
her h
and,
lega
cy sy
stem
s will
per
sist
long
into
the
futu
re a
nd it
is th
eref
ore
nece
ssar
y th
at a
stan
dard
-com
plia
nt E
HR
RA
mus
t be
able
to su
ppor
t leg
acy
data
.
ISO
Sec
tion
8.1
Supp
ort f
or E
HR
arc
hite
ctur
e an
d EH
R s
yste
m e
volu
tion
ISO
R
eq’t
Des
crip
tion
open
EHR
art
ifact
Con
form
ance
EVO
1.1
Bac
kwar
ds c
ompa
tibili
ty o
f EH
R s
oftw
are:
Any
impl
emen
tatio
n of
the
EHR
RA
mus
t be
able
to p
roce
ss E
HR
s cr
eate
d un
der o
lder
ver
sion
s of
the
EHR
RA
(10.
1.1)
This
requ
irem
ent i
s sat
isfie
d by
the
use
of a
ppro
pria
te ru
les f
orw
hat c
onst
itute
s a
new
ver
sion
of
the
open
EHR
arc
hite
ctur
e.N
ew s
oftw
are
vers
ions
are
not
allo
wed
to in
valid
ate
prev
ious
data
mod
el e
lem
ents
, onl
y ad
d ne
w o
nes,
guar
ante
eing
bac
k-w
ards
com
patib
ility
of s
oftw
are.
Des
ign:
Ful
l
EVO
1.2
Bac
kwar
ds c
ompa
tibili
ty o
f the
EH
R: S
oftw
are
built
on
a pr
evio
us v
er-
sion
of t
he E
HR
RA
mus
t be
capa
ble
of p
roce
ssin
g EH
Rs c
reat
ed u
nder
ane
wer
ver
sion
of t
he E
HR
RA
(10.
1.1)
This
requ
irem
ent i
s sat
isfie
d by
the
use
of a
ppro
pria
te ru
les f
orw
hat c
onst
itute
s a
new
ver
sion
of
the
open
EHR
arc
hite
ctur
e.N
ew v
ersi
ons a
re n
ot a
llow
ed to
inva
lidat
e pr
evio
us d
ata
mod
-el
ele
men
ts, o
nly
add
new
one
s, gu
aran
teei
ng fo
rwar
d co
mpa
t-ib
ility
of d
ata.
Des
ign:
Ful
l
EVO
1.3
The
EHR
RA
mus
t be
able
to a
ccom
mod
ate
the
reco
rdin
g of
info
rmat
ion
due
to n
ew f
orm
s of
clin
ical
kno
wle
dge,
new
clin
ical
dis
cipl
ines
, and
new
clin
ical
pra
ctic
es a
nd p
roce
sses
(10.
1.1)
The
open
EHR
two-
leve
l mod
ellin
g ap
proa
ch (b
otto
m le
vel =
refe
renc
e m
odel
s; s
econ
d le
vel =
dom
ain
conc
ept m
odel
s, or
arch
etyp
es) i
s des
igne
d pr
ecis
ely
to sa
tisfy
this
requ
irem
ent i
na
form
al, s
yste
mat
ic w
ay.
Des
ign:
Ful
l
ISO 18308 Conformance Statement MappingsRev 1.5
Author: T Beale Page 43 of 51 Date of Issue:09 Sep 2006
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
Mappings ISO 18308 Conformance StatementRev 1.5
Date of Issue:09 Sep 2006 Page 44 of 51 Author: T Beale
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
ISO 18308 Conformance Statement Summary of Conformance ExceptionsRev 1.5
3 Summary of Conformance Exceptions1 Exception - TBD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142 Exception - Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183 Exception - Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214 Exception - Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215 Exception - Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216 Exception - TBD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267 Exception - Part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268 Exception - TBD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 289 Exception - Part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2910 Exception - Fut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3011 Exception - TBD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3012 Exception - Part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3113 Exception - TBD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3214 Exception - Fut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3215 Exception - Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3216 Exception - Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3417 Exception - Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3518 Exception - Full . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3619 Exception - TBD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Author: T Beale Page 45 of 51 Date of Issue:09 Sep 2006
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
Summary of Conformance Exceptions ISO 18308 Conformance StatementRev 1.5
Date of Issue:09 Sep 2006 Page 46 of 51 Author: T Beale
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
ISO 18308 Conformance Statement ISO Requirements Requiring ReviewRev 1.5
4 ISO Requirements Requiring ReviewTBR 1:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Author: T Beale Page 47 of 51 Date of Issue:09 Sep 2006
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
ISO Requirements Requiring Review ISO 18308 Conformance StatementRev 1.5
Date of Issue:09 Sep 2006 Page 48 of 51 Author: T Beale
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
ISO 18308 Conformance Statement ReferencesRev 1.5
A ReferencesPublications
1 Beale T. Archetypes: Constraint-based Domain Models for Future-proof Information Systems. See http://www.deepthought.com.au/it/archetypes.html.
2 Beale T et al. Design Principles for the EHR. See http://www.deepthought.com.au/openEHR.
3 Fowler M, Scott K. UML Distilled (2nd Ed.). Addison Wesley Longman 2000
4 Kalra D. (Editor). The Synapses User Requirements and Functional Specification (Part A). EU Telematics Application Programme, Brussels; 1996; The Synapses Project: Deliverable USER 1.1.1a. 6 chapters, 176 pages.
5 Kalra D. (Editor). Synapses ODP Information Viewpoint. EU Telematics Application Pro-gramme, Brussels; 1998; The Synapses Project: Final Deliverable. 10 chapters, 64 pages.
6 Meyer B. Object-oriented Software Construction, 2nd Ed. Prentice Hall 1997
7 Schadow G, McDonald C J. The Unified Code for Units of Measure, Version 1.4, April 27, 2000. Regenstrief Institute for Health Care, Indianapolis. See http://aurora.rg.iu-pui.edu/UCUM
8 Walden K, Nerson J. Seamless Object-oriented Software Architecture. Prentice Hall 1994
Resources
9 GEHR Australia: http://www.gehr.org.
10 GEHR - Good European Health Record. Available at http://www.chime.ucl.ac.uk/.
Author: T Beale Page 49 of 51 Date of Issue:09 Sep 2006
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
References ISO 18308 Conformance StatementRev 1.5
Date of Issue:09 Sep 2006 Page 50 of 51 Author: T Beale
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
ISO 18308 Conformance StatementRev 1.5
Author: T Beale Page 51 of 51 Date of Issue:09 Sep 2006
© 2002-2006 The openEHR Foundationemail: [email protected] web: www.openEHR.org
END OF DOCUMENT
