SIST EN ISO 12967-1:2011
(Main)Health informatics - Service architecture - Part 1: Enterprise viewpoint (ISO 12967-1:2009)
Health informatics - Service architecture - Part 1: Enterprise viewpoint (ISO 12967-1:2009)
This part of ISO 12967 provides guidance for the description, planning and development of new systems, as well as for the integration of existing information systems, both within one enterprise and across different healthcare organizations, through an architecture integrating the common data and business logic into a specific architectural layer (i.e. the middleware), distinct from individual applications and accessible throughout the whole information system through services.
This part of ISO 12967 is also independent from, and does not imply either explicitly or implicitly, any specific technological solution or product for its deployment. Accordingly, the formalization of the architecture according to two lower levels of the ODP reference model, the engineering and technology viewpoints, is outside the scope of this part.
The language and notations used here for specifying the architecture are based on UML (Unified Modelling Language) complemented by case studies and other paradigms widely utilized by other standards in health informatics. The level of the specification is complete and non-ambiguous enough to allow its implementation into the specific physical and technological scenarios adopted by the various healthcare organizations and vendors. For this exercise, it is recommended to follow the methodology formalized by the engineering and Technology viewpoints of the RM ODP Reference model1).
Medizinische Informatik - Servicearchitektur - Teil 1: Unternehmenssicht (ISO 12967-1:2009)
Informatique de santé - Architecture de service - Partie 1: Point de vue d'entreprise (ISO 12967-1:2009)
L'ISO 12967-1:2009 donne les lignes directrices de description, de planification et de développement de nouveaux systèmes et d'intégration des systèmes d'information existants, tant dans le cadre d'une entreprise qu'entre organismes de santé, grâce à la mise en place d'une architecture intégrant les données communes et la logique applicative dans une couche architecturale spécifique (à savoir la couche interstitielle), distincte des applications individuelles et accessible par tous les systèmes d'informations grâce à des services.
Zdravstvena informatika - Arhitektura storitve - 1. del: Podjetniški vidik (ISO 12967-1:2009)
Ta del ISO 12967 podaja smernice za opisovanje, načrtovanje in razvoj novih sistemov ter integracijo obstoječih informacijskih sistemov v enem podjetju in med različnimi zdravstvenimi organizacijami v okviru arhitekture, ki integrira podatke in poslovno logiko v določeno arhitekturno plast (tj. vmesna programska oprema) ter se razlikuje od posameznih uporab in je dostopna v celotnem informacijskem sistemu prek storitev.
Ta del ISO 12967 prav tako ni odvisen in ne navaja eksplicitno niti implicitno katere koli določene tehnološke rešitve ali proizvoda za njeno postavitev. Temu ustrezno je formalizacija arhitekture v skladu z dvema spodnjima nivojema referenčnega modela ODP ter inženirskimi in tehnološkimi vidiki zunaj področja uporabe tega dela.
Jezik in oznake, ki se tu uporabljajo za določanje arhitekture, so zasnovane na UML (poenoten jezik modeliranja), ki je dopolnjen s študijami primerov in drugimi paradigmami, široko uporabljenimi v drugih standardih in zdravstveni informatiki. Stopnja specifikacije je celotna in dovolj nedvoumna, da dopušča njeno implementacijo v določene fizične in tehnološke scenarije, ki jih uporabljajo zdravstvene organizacije in prodajalci. Za tako izvrševanje je priporočeno slediti metodologiji, oblikovani z inženirskimi in tehnološkimi vidiki referenčnega modela RM ODP.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 12967-1:2011
01-julij-2011
1DGRPHãþD
SIST EN 12967-1:2008
Zdravstvena informatika - Arhitektura storitve - 1. del: Podjetniški vidik (ISO 12967-
1:2009)
Health informatics - Service architecture - Part 1: Enterprise viewpoint (ISO 12967-
1:2009)
Medizinische Informatik - Servicearchitektur - Teil 1: Unternehmenssicht (ISO 12967-
1:2009)
Informatique de santé - Architecture de service - Partie 1: Point de vue d'entreprise (ISO
12967-1:2009)
Ta slovenski standard je istoveten z: EN ISO 12967-1:2011
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 12967-1:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 12967-1:2011
---------------------- Page: 2 ----------------------
SIST EN ISO 12967-1:2011
EUROPEAN STANDARD
EN ISO 12967-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2011
ICS 35.240.80 Supersedes EN 12967-1:2007
English Version
Health informatics - Service architecture - Part 1: Enterprise
viewpoint (ISO 12967-1:2009)
Informatique de santé - Architecture de service - Partie 1: Medizinische Informatik - Servicearchitektur - Teil 1:
Point de vue d'entreprise (ISO 12967-1:2009) Unternehmenssicht (ISO 12967-1:2009)
This European Standard was approved by CEN on 10 March 2011.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12967-1:2011: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 12967-1:2011
EN ISO 12967-1:2011 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 12967-1:2011
EN ISO 12967-1:2011 (E)
Foreword
The text of ISO 12967-1:2009 has been prepared by Technical Committee ISO/TC 215 “Health informatics” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 12967-1:2011 by
Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by September 2011, and conflicting national standards shall be
withdrawn at the latest by September 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 12967-1:2007.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 12967-1:2009 has been approved by CEN as a EN ISO 12967-1:2011 without any
modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 12967-1:2011
---------------------- Page: 6 ----------------------
SIST EN ISO 12967-1:2011
INTERNATIONAL ISO
STANDARD 12967-1
First edition
2009-08-15
Health informatics — Service
architecture —
Part 1:
Enterprise viewpoint
Informatique de santé — Architecture de service —
Partie 1: Point de vue d'entreprise
Reference number
ISO 12967-1:2009(E)
©
ISO 2009
---------------------- Page: 7 ----------------------
SIST EN ISO 12967-1:2011
ISO 12967-1:2009(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2009
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2009 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 12967-1:2011
ISO 12967-1:2009(E)
Contents Page
Foreword .v
Introduction.vi
1 Scope.1
2 Normative references.2
3 Terms and definitions .2
3.1 System concepts .2
3.2 Concepts relating to organization .3
3.3 Community concepts .3
3.4 Behaviour concepts .4
3.5 Policy concepts .5
3.6 Accountability concepts.5
4 Symbols and abbreviations.7
5 Methodology for the specification of the architecture .7
5.1 Viewpoints for the specification of the architecture.7
5.2 The HISA specification procedure.8
5.2.1 The Strategic Paradigm.8
5.2.2 Specification of the enterprise viewpoint .9
5.2.3 Specification of the information viewpoint.9
5.2.4 Specification of the computational viewpoint.10
5.3 Iterative specification.10
5.4 Viewpoints specification languages and notations.11
6 HISA overview.11
6.1 General requirement.11
6.2 Enterprise viewpoint.12
6.3 Information viewpoint .13
6.4 Computational viewpoint.14
7 Methodology for extensions.14
8 Conformance criteria.15
8.1 Conformance of specification documents to the HISA methodology .15
8.2 Conformance of middleware products to the HISA architectural requirements .15
9 The HISA Enterprise viewpoint .16
9.1 Introduction (informative).16
9.1.1 General.16
9.1.2 The regional, inter-enterprise perspective.17
9.1.3 The medical/clinical perspective .17
9.1.4 The operational/clinical and organizational process model perspective.19
9.1.5 The Healthcare Information Services and their complexity.25
9.2 The fundamental workflows and groups of users’ activities to be supported by the
middleware.25
9.3 General information requirements for all users’ activities .26
9.3.1 Introduction.26
9.3.2 Common attributes.26
9.3.3 Extensibility.27
9.3.4 Versioning.27
9.3.5 Auditing.27
9.3.6 Handling of life cycle.27
9.4 Subject of care workflow .28
© ISO 2009 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 12967-1:2011
ISO 12967-1:2009(E)
9.4.1 Textual description of requirements.28
9.4.2 Use-case examples (informative).30
9.5 Clinical information workflow.33
9.5.1 Textual specification of requirements.33
9.5.2 Use-case examples (informative).34
9.6 Activity management workflow.35
9.6.1 Textual description of requirements.35
9.6.2 Use-case examples (informative).38
9.7 Resources management activities/Textual description of requirements .40
9.8 Management activities for users and authorizations/Textual description of requirements .41
9.9 Classifications, coding and dictionaries management activities/Textual description of
requirements .42
Annex A (informative) Highlights of Open Distributed Processing (ODP).45
Annex B (informative) Rationale for the federative structure of the Health Informatics Service
Architecture.48
Bibliography .51
iv © ISO 2009 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 12967-1:2011
ISO 12967-1:2009(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 12967-1 was prepared by Technical Committee ISO/TC 215, Health informatics, based on the European
Standard EN 12967-1:2007 with minor editorial amendments.
ISO 12967 consists of the following parts, under the general title Health informatics — Service architecture:
⎯ Part 1: Enterprise viewpoint
⎯ Part 2: Information viewpoint
⎯ Part 3: Computational viewpoint
© ISO 2009 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 12967-1:2011
ISO 12967-1:2009(E)
Introduction
The healthcare organizational structure consists of networks of centres (hospital cooperations within, for
example, counties, individual hospitals, clinics, etc.) distributed over the territory, characterized by a high
degree of heterogeneity and diversity, from organizational, logistic, clinical, technological and even cultural
perspectives. The structure of individual centres evolves from a vertical, aggregated organization towards the
integration of a set of specialized functional areas (e.g. unit of laboratory analyses, unit of surgery), with
specific needs and characteristics, nevertheless needing to share common information and to operate
according to integrated workflows. Such a situation determines two main needs which conflict with each other
in a certain way. On the one hand it is necessary to effectively support the specific requirements of each unit
or user in the most appropriate and cost-effective way whilst, on the other hand, it is vital to ensure the
consistency and integration of the overall organization, at local and territorial levels. This integration
requirement is not only related to the need for improving clinical treatments to the subject of care but is also
demanded by the urgent necessity of all countries to control and optimize the current level of expenditure for
health, whilst ensuring the necessary qualitative level of services to all subjects of care.
The large number of databases and applications, mutually isolated and incompatible, which are already
available on the market and operational in healthcare organizations to support specific needs of users, cannot
be underestimated. Even within the same centre, healthcare information systems are frequently fragmented
across a number of applications, data and functionalities, isolated and scarcely consistent with each other.
In the present circumstances, the main need for care delivery organizations is to integrate and to make
available the existing information assets, and to make possible the integration and interoperability of existing
applications, thereby protecting investments. During integration activities, continuity of service needs to be
achieved whilst gradual migration of existing proprietary, monolithic systems towards the new concepts of
openness and modularity occurs. The cost-effectiveness of the solutions, especially when projected on the
scale of the whole healthcare organization, represents another crucial aspect to be evaluated carefully.
The goal can be achieved through a unified, open architecture based on middleware independent from
specific applications and capable of integrating common data and business logic and of making them
available to diverse, multi-vendor applications through many types of deployment. According to the integration
objectives at organizational level, all aspects (i.e. clinical, organizational and managerial) of the healthcare
structure must be supported by the architecture, which must therefore be able to comprise all relevant
information and all business workflows, structuring them according to criteria and paradigms independent from
specific sectorial aspects, temporary requirements or technological solutions.
Standards and technological solutions already exist and will continue to be defined for supporting specific
requirements, both in terms of in situ user operations and with respect to the movement of information. The
architecture must be able to accommodate such requirements by allowing the specific models to be integrated
with the complete information assets of the healthcare organization and the communication messages to be
“services” extracting or importing data from/to the common information shown in Figure 1.
On the basis of these considerations, the purpose of ISO 12967 is twofold:
⎯ identify a methodology to describe healthcare information systems through a language, notation and
paradigms suitable to facilitate the planning, design and comparison of systems;
⎯ identify the fundamental architectural aspects enabling the openness, integration and interoperability of
healthcare information systems.
The architecture is therefore intended as a basis both for working with existing systems and for the planning
and construction of new systems.
vi © ISO 2009 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 12967-1:2011
ISO 12967-1:2009(E)
Specific models & communication interfaces
(e.g. RIM, DICOM, GPICs, etc.)
CommoCno,mmo neutnra, nl,e ourtgraaln, isaortgaionnization - w-idew HidIe HSA mISoAde mol del
CCoommommonn,, n neeuuttrarall,, H HIISSAA momoddeell
Integrated and consistent heritage of all
common enterprise data end common business logic
Figure 1 — Complementarity and positioning of the architecture with other standards and models
It is pointed out that ISO 12967 does not aim to define a unique model for clinical, organizational, managerial
or administrative activities, but rather defines a set of workflows, information and services common to all
healthcare information systems, relevant for any healthcare sector and usable by any application also for
facilitating the mutual interworking.
Similarly, ISO 12967 does not aim to represent a final, complete set of specifications. On the contrary, it
formalizes only fundamental aspects, identified as common in all countries and considered to be currently
essential in any advanced healthcare information system. Specifications are formalized, avoiding any
dependency on specific technological products and/or solutions.
ISO 12967, therefore, is an open framework that, according to the specification methodology and preserving
the compatibility with previous versions, can be extended during time according to the evolution of the
healthcare organization both in the individual (national and local) contexts and through international
standardization initiatives.
A European pre-standard, ENV 12967-1, developed according to such rationale during 1993 to 1997 and
published in 1998, was the basis for implementations of middleware products and implemented integrations in
healthcare regions in several countries. In 2000, the CEN/TC 251 Short Strategic Study on Health Information
Infrastructure identified a number of other new architectures and health infrastructure initiatives, as well as the
requirements and possibilities for alignment with the large body of information model standards developed by
CEN for various communication purposes. European standardization initiatives have delivered a number of
object-oriented domain models and message descriptions that include an architecture for the Electronic
Health Record (ISO 13606). Cooperation between CEN and HL7 was started in the year 2000, and on the
basis of the CEN modelling principles and the HL7 Reference Information Model, this led to the definition of a
set of “General Purpose Information Components” (GPICs) usable for developing messages.
The formal major revision of the pre-standard to a European standard was started in 2003 and in 2007 this led
to the publication of the EN 12967 Parts 1 to 3 series on which ISO 12967 is based.
The following characteristics of ISO 12967 can be highlighted as follows.
⎯ The architecture is described according to the methodology of ISO/IEC 10746 (all parts), to provide a
formal, comprehensive and non-ambiguous specification suitable to serve as a reference in the planning,
design and implementation of healthcare information systems.
⎯ The scope of the architecture comprises the support to the activities of the healthcare organization as a
whole, from the clinical, organizational and managerial point of view. It therefore does not detail
specificities of different subdomains, but provides an overarching comprehensive information and
services framework to accommodate requirements.
© ISO 2009 – All rights reserved vii
---------------------- Page: 13 ----------------------
SIST EN ISO 12967-1:2011
ISO 12967-1:2009(E)
⎯ The architecture is intrinsically compatible, complementary and synergistic with other models and
standards, such as HL7 RIM, the derived GPICs and the Electronic Health Record Architecture
ISO 13606. A separate mapping document between this HISA standard and HL7 RIM was produced
during the ISO process. Specific information objects and services are explicitly foreseen in the
architecture to facilitate the implementation of views and communication mechanisms based on such
standards.
⎯ Many of the basic concepts of ISO 12967 are aligned with EN 13940, Health informatics — System of
concepts to support continuity of care that, in June 2008, it was agreed to process also as an
International Standard.
ISO 12967 consists of three parts:
⎯ Part 1 (this part) specifies the overall characteristics of the architecture, formalizes the specification
methodology and the conformance criteria, and provides details of the enterprise viewpoint of the
architecture;
⎯ Part 2 specifies the information viewpoint of the architecture;
⎯ Part 3 specifies the computational viewpoint of the architecture.
Each part is self-consistent and is also independently utilizable for the intended purposes by different types of
users (this part being more oriented to the managerial level, Parts 2 and 3 being more dedicated to the design
activities). Nevertheless, it must be understood that they represent three aspects of the same architecture.
Mutual references therefore exist between the different parts and evolutions of the individual documents must
be carried out according to the defined methodology to preserve the overall integrity and consistency of the
specification.
The overall architecture is formalized according to ISO/IEC 10746 (all parts) and is therefore structured
through the following three viewpoints.
a) Enterprise viewpoint: specifies a set of fundamental common requirements at enterprise level with
respect to the organizational purposes, scopes and policies that must be supported by the information
and functionality of the middleware. It also provides guidance on how one individual enterprise (e.g. a
regional healthcare authority, a large hospital or any other organization where this model is applicable)
can specify and document additional specific business requirements, with a view to achieving a complete
specification, adequate for the characteristics of that enterprise.
Enterprise viewpoint is specified in this part of ISO 12967.
b) Information viewpoint: specifies the fundamental semantics of the information model to be implemented
by the middleware to integrate the common enterprise data and to support the enterprise requirements
formalized in this part of ISO 12967. It also provides guidance on how one individual enterprise can
extend the standard model with additional concepts needed to support local requirements in terms of
information to be put in common.
Information viewpoint is specified in ISO 12967-2.
c) Computational viewpoint: specifies the scope and characteristics of the services that must be provided by
the middleware for allowing access to the common data as well as the execution of the business logic
supporting the enterprise processes identified in the information viewpoint and in this part of ISO 12967. It
also provides guidance on how one individual enterprise can specify additional services needed to
support local specific requirements in terms of common business logic to be implemented.
Computational viewpoint is specified in ISO 12967-3.
viii © ISO 2009 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 12967-1:2011
INTERNATIONAL STANDARD ISO 12967-1:2009(E)
Health informatics — Service architecture —
Part 1:
Enterprise viewpoint
1 Scope
This part of ISO 12967 provides guidance for the description, planning and development of new systems, as
well as for the integration of existing information systems, both within one enterprise and across different
healthcare organizations, through an ar
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.