SIST EN 12967-1:2008

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Health informatics - Service architecture - Part 1: Enterprise viewpointZdravstvena informatika - Arhitektura storitve - 1. del: Vidik podjetjaInformatique de la santé - Architecture de service - Partie 1 : Point de vue EntrepriseMedizinische Informatik - Servicearchitektur - Teil 1: UnternehmenssichtTa slovenski standard je istoveten z:EN 12967-1:2007SIST EN 12967-1:2008en35.240.80ICS:SIST ENV 12967-1:20031DGRPHãþDSLOVENSKI
STANDARDSIST EN 12967-1:200801-maj-2008







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 12967-1October 2007ICS 35.240.80Supersedes ENV 12967-1:1998
English VersionHealth informatics - Service architecture - Part 1: EnterpriseviewpointInformatique de la santé - Architecture de service - Partie 1: Point de vue EntrepriseMedizinische Informatik - Servicearchitektur - Teil 1:UnternehmenssichtThis European Standard was approved by CEN on 16 September 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 12967-1:2007: E



EN 12967-1:2007 (E) 2 Contents Page Foreword.4 Introduction.5 1 Scope.8 2 Normative references.9 3 Terms and definitions.9 3.1 System concepts.9 3.2 Concepts relating to organisation.10 3.3 Community concepts.10 3.4 Behaviour concepts.11 3.5 Policy concepts.12 3.6 Accountability concepts.13 4 Symbols and abbreviations.14 5 Methodology for the specification of the architecture.14 5.1 The viewpoints for the specification of the architecture.14 5.2 The HISA specification procedure.15 5.2.1 The strategic paradigm.15 5.2.2 Specification of the Enterprise viewpoint.16 5.2.3 Specification of the Information viewpoint.17 5.2.4 Specification of the Computational viewpoint.17 5.3 Iterative specification.18 5.4 Viewpoints specification languages and notations.18 6 HISA overview.19 6.1 General requirement.19 6.2 Enterprise viewpoint.19 6.3 Information viewpoint.20 6.4 Computational viewpoint.21 7 The methodology for extensions.22 8 Conformance criteria.23 8.1 Conformance of specification documents to the HISA methodology.23 8.2 Conformance of middleware products to the HISA architectural requirements.23 9 The HISA Enterprise viewpoint.24 9.1 Introduction (informative).24 9.1.1 General.24 9.1.2 The regional, inter-enterprise perspective.24 9.1.3 The medical/clinical perspective.25 9.1.4 The operational/clinical and organisational process model perspective.26 9.1.5 The Healthcare Information Services and their complexity.32 9.2 The fundamental workflows and groups of users’ activities to be supported by the middleware.32 9.3 General information requirements for all users’ activities.34 9.3.1 Introduction.34 9.3.2 Common attributes.34 9.3.3 Extensibility.34 9.3.4 Versioning.35 9.3.5 Auditing.35 9.3.6 Handling of lifecycle.35 9.4 Subject of Care workflow.36



EN 12967-1:2007 (E) 3 9.4.1 Textual description of requirements.36 9.4.2 Use case examples (informative).38 9.5 Clinical information workflow.42 9.5.1 Textual specification of requirements.42 9.5.2 Use case examples (informative).43 9.6 Activity management workflow.44 9.6.1 Textual description of requirements.44 9.6.2 Use case examples (informative).47 9.7 Resources management activities / Textual description of requirements.50 9.8 Users and Authorisations management activities / Texutual description of requirements.50 9.9 Classifications, coding and dictionaries management activities / Textual description of requirements.52 Annex A (informative) Highlights on ODP.55 Annex B (informative) Rationale on the federative structure of the Health Informatics Systems architecture.58 Bibliography.61



EN 12967-1:2007 (E) 4 Foreword This document (EN 12967-1:2007) has been prepared 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 April 2008, and conflicting national standards shall be withdrawn at the latest by April 2008. This document, together with EN 12967-2 and EN 12967-3, supersedes ENV 12967-1:1998. This three part European standard is a major revision of the ENV 12967-1 that was produced under a mandate given to CEN by the European Commission and the European Free Trade Association. This multi-part standard under the general heading: Health informatics – Service architecture consists of the following parts: Part 1: Enterprise viewpoint Part 2: Information viewpoint Part 3: Computational viewpoint Parts 1, 2 and 3 are jointly replacing ENV 12967-1:1997 Medical informatics – Healthcare Information System Architecture (HISA) - Part 1: Healthcare middleware layer. 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, 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.



EN 12967-1:2007 (E) 5 Introduction Healthcare organisational structure consists of networks of centres (hospital co-operations within e.g. counties, individual hospitals, clinics etc.) distributed over the territory, characterised by a high degree of heterogeneity and diversity, from organisational, logistic, clinical, technological and even cultural perspectives. The structure of individual centres is evolving from a vertical, aggregated organisation towards the integration of a set of specialised 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 organisation, both at local and territorial level.
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 optimise 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 organisations 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. Under the present circumstances, the main need for care delivery organisations is to integrate and to make available the existing information assets, 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 organisation, represents another crucial aspect to be evaluated carefully.
The goal can be achieved through a unified, open architecture based on a 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 organisational level, all aspects (i.e. clinical, organisational and managerial) of the healthcare structure must be supported by the architecture, which must be able therefore 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 organisation and the communication messages to be “services” extracting or importing data from/to the common information as shown in Figure 1. On the basis of these considerations, the purpose of this standard 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 as well as for the planning and construction of new systems.



EN 12967-1:2007 (E) 6
Figure 1 — Complementarity and positioning of the architecture with other standards and models It is pointed out that this standard does not aim at defining a unique model for clinical, organisational, 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, the standard does not aim to represent a final, complete set of specifications. On the contrary, it formalises only fundamental aspects, identified as common in all European countries and considered to be - today - essential in any advanced healthcare information system. Specifications are formalised, avoiding any dependency on specific technological products and/or solutions.
The standard, 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 organisation both in the individual - national and local - contexts and through international standardisation initiatives.
A European pre-standard, ENV 12967-1, was developed according to such rationale during 1993 to 1997 and has been the basis for several implementations of middleware products and implemented integrations in healthcare regions. In 2000 the CEN/TC 251 Short Strategic Study on Health Information Infrastructure also 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. Furthermore, European standardization initiatives have delivered a number of object oriented domain models and message descriptions that include an architecture for the Electronic Health Record (EN 13606). Cooperation between CEN and HL7 has also started, that, on the basis of the CEN modelling principles and HL7 Reference Information Model, has led to the definition of a set of “General Purpose Information Components”, usable for developing messages across information systems. This standard evolves and refines the ENV 12967-1 pre-standard taking into account the outcomes from its practical utilisations during the past years, as well as the other above-mentioned initiatives occurred in CEN. With such a view, the following qualifying aspects can be highlighted:  architecture is described according to the methodology of ISO/IEC 10746 (all parts) Information technology - Open Distributed Processing – Reference model, to provide a formal, comprehensive and non ambiguous specification suitable to serve as term of reference in the planning, design and implementation of healthcare information systems.
 scope of the architecture comprises the support to the activities of the healthcare organisation as a whole, from the clinical, organisational and managerial point of view. It therefore does not detail specificities of



EN 12967-1:2007 (E) 7 different subdomains, but provides overarching comprehensive information and services framework to accommodate requirements.  according to its scope, the architecture is intrinsically compatible, complementary and synergistic with other models and standards - such as HL7 and GPICS - defined in the scenario of the healthcare IT during the past years to support specific healthcare areas and communications across healthcare information systems. Moreover, specific information objects and services are explicitly foreseen in the architecture to facilitate the implementation of views and communication mechanisms based on such standards.  order to protect investments made by industrial and healthcare organisations on the basis of the pre-standard, the current specification is compatible, as much as possible, with the model and provisions defined in the ENV, by extending and refining them according to the new requirements.



EN 12967-1:2007 (E) 8 1 Scope This European standard 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 organisations 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, as shown in Figure 2
Figure 2 The architectural principles are formalised according to the ISO/IEC 10746 (all parts) criteria and are therefore structured through the following three viewpoints: a) Enterprise viewpoint that specifies a set of fundamental common requirements at enterprise level with respect to the organisational purposes, scopes and policies that must be supported by the information and functionalities of the middleware. It also provides guidance on how one individual enterprise (e.g. a regional healthcare authority, a large hospital or any other where this model is applicable) may specify and document additional specific business requirements, with a view of achieving a complete specification, adequate for the characteristics of that enterprise.
b) Information viewpoint that 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 formalised in the Enterprise viewpoint. It also provides guidance on how one individual enterprise may extend the standard model with additional concepts, needed to support local requirements in terms of information to be put in common. c) Computational viewpoint that specifies the scope and characteristics of the services that must be provided by the middleware for allowing the access to the common data as well as the execution of the business logic supporting the enterprise processes identified in the Information and Enterprise viewpoints. It also provides guidance on how one individual enterprise may specify additional services, needed to support local specific requirements in terms of business logic to be put in common. The standard is also independent from, and does not imply either explicitly or implicitly, any specific technological solution or product for its deployment. Accordingly, the formalisation of the architecture according to two lower levels of the ODP reference model, the Engineering and Technology viewpoints is outside the scope of this standard. 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 utilised 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 organisations and



EN 12967-1:2007 (E) 9 vendors. For this exercise it is recommended to follow the methodology formalised by the Engineering and Technology viewpoints of the ISO ODP Reference model1. The standard is organised in three parts:  Part 1 (this part) specifies the overall characteristics of the architecture, formalises the specification methodology and the conformance criteria, details 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 document is self-consistent and is independently utilisable for the intended purposes also by different types of users (Part 1 being more oriented to the managerial level, Parts 2 and 3 being more dedicated to the design activities). Nevertheless, it should 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 shall be carried out according to the defined methodology to preserve the overall integrity and consistency of the specification. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO/IEC 10746-1:1998, Information technology – Open Distributed Processing – Reference model: Overview ISO/IEC 10746-2:1996, Information technology – Open Distributed Processing – Reference model: foundations ISO/IEC 10746-3:1996, Information technology – Open Distributed Processing – Reference model: Architecture ISO/IEC 10746-4:1998, Information technology – Open Distributed Processing – Reference model: Architectural semantics 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 System concepts 3.1.1 scope (of a system) behaviour the system is expected to exhibit towards the enterprise it serves 3.1.2 field of application (of a specification) properties the environment of the ODP system must have for the specification of that system to be viable
1 For more introductory material on RM-ODP and many guideline documents see WWW.RM-OPD.NET



EN 12967-1:2007 (E) 10 3.1.3 information service ability of the system to provide a defined set of output information based on a defined set of input information. The term information service is consistently used in this standard for the services provided by the information system NOTE The healthcare information services (HCIS) are the healthcare related services provided by healthcare information systems. 3.1.4 viewpoint viewpoint (on a system) is an abstraction that yields a specification of the whole system related to a particular set of concerns 3.1.5 middleware middleware is the enabling technology of enterprise application integration (EAI). It describes a piece of software that connects two or more software applications so that they can exchange data NOTE Common programming interfaces between applications are considered middleware. For example, Open Database Connectivity (ODBC) enables applications to make a standard call to all the databases that support the ODBC interface. 3.1.6 enterprise application integration (EAI) use of software and computer systems architectural principles to integrate a set of enterprise computer applications 3.2 Concepts relating to organisation 3.2.1 organisation
group of people and facilities with an arrangement of responsibilities, authorities and relationships
[EN ISO 9000] NOTE 1 The arrangement is generally orderly. NOTE 2 An organisation can be public or private. NOTE 3 This standard deals with healthcare organisations, ranging from hospital co-operations within e.g. counties, over individual hospitals, to individual clinics etc. encompassing only specific subsets of normal hospital services. 3.2.2 organisational structure
arrangement of responsibilities, authorities and relationships between people NOTE 1 The arrangement is generally orderly. NOTE 2 A formal expression of the organisational structure is often provided.
NOTE 3 The scope of an organisational structure can include relevant interfaces to external organisations. 3.3 Community concepts 3.3.1 community configuration of objects formed to meet an objective



EN 12967-1:2007 (E) 11 NOTE The objective is expressed as a contract, which specifies how the objective can be met
3.3.2 federation community of domains 3.3.3 objective practical advantage or intended effect, expressed as preferences about future states NOTE 1 Some objectives are ongoing, some are achieved once met. NOTE 2 In the text of ITU-T Rec. X.903 | ISO/IEC 10746-3 [3-5] the terms, purpose and objective, are synonymous. The enterprise language systematically uses the term, objective, and emphasises the need of expressing objective in measurable terms. 3.3.4 community object composite enterprise object that represents a community. Components of a community object are objects of the community represented 3.4 Behaviour concepts 3.4.1 actor (with respect to an action) enterprise object that participates in the action NOTE It may be of interest to specify which actor initiate that action. 3.4.2 artefact (with respect to an action) enterprise object that is referenced in the action NOTE An enterprise object that is an artefact in one action can be an actor in another action. 3.4.3 resource enterprise object which is essential to some behaviour and which requires allocation or may become unavailable NOTE 1 Allocation of a resource may constrain other behaviours for which that resource is essential. NOTE 2 A consumable resource may become unavailable after some amount of use or after some amount of time (in ca
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