oSIST prEN 12967-1:2006

Health Informatics - Healthcare Information System Architecture (HISA) - Part 1: Healthcare Middleware Layer

Migrated from Progress Sheet (TC Comment) (2000-07-10): Conversion of ENV 12967-1:1998 (TC Res 480/1998) (CC/980730)

Zdravstvena informatika – Arhitektura storitve – 1. del: Vidik podjetja

General Information

• Status: Not Published
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 31-Jan-2011
• Due Date: 05-Feb-2011
• Completion Date: 31-Jan-2011
• Ref Project: prEN 12967-1 - Health Informatics - Healthcare Information System Architecture (HISA) - Part 1: Healthcare Middleware Layer

Standards Content (Sample)

EUROPEAN STANDARD
DRAFT
prEN 12967-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2006
ICS Will supersede ENV 12967-1:1998
English Version
Health Informatics - Service architecture - Part 1: Enterprise
viewpoint
Informatique de santé - Service architecture - Partie 1 :
Point de vue d'entreprise
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 251.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 12967-1:2006: E
worldwide for CEN national Members.

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prEN 12967-1:2006 (E)
Contents
Foreword . 4
Introduction. 5
1 Scope . 7
2 Normative references. 8
3 Terms and definitions . 10
3.1 System concepts . 10
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 Abbreviations. 14
5 Methodology for the specification of the architecture . 15
5.1 The viewpoints for the specification of the architecture. 15
5.2 The HISA specification procedure. 16
5.2.1 The strategic paradigm . 16
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. 18
5.3 Iterative specification. 18
5.4 Viewpoints specification languages and notations. 19
6 HISA overview. 19
6.1 General requirement . 19
6.2 Enterprise viewpoint . 20
6.3 Information viewpoint . 21
6.4 Computational viewpoint. 22
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. 24
9.1.1 The regional, inter-enterprise perspective. 24
9.1.2 The medical/clinical perspective . 24
9.1.3 The operational/clinical and organisational process model perspective. 26
9.1.4 The Healthcare Information Services and their complexity. 31
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 .33
9.3.1 Introduction. 33
9.3.2 Common attributes. 33
9.3.3 Extensibility. 33
9.3.4 Versioning . 34
9.3.5 Auditing . 34
9.3.6 Handling of lifecycle. 34
9.4 Subject of Care workflow. 34
9.4.1 Textual description of requirements . 34
9.4.2 Use case examples. 37
9.5 Clinical information workflow . 40
9.5.1 Textual specification of requirements. 40
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9.5.2 Use case examples .41
9.6 Activity management workflow .42
9.6.1 Textual description of requirements.42
9.6.2 Use case examples .45
9.7 Resources management activities.47
9.7.1 Textual description of requirements.47
9.8 Users and Authorisations management activities .48
9.8.1 Textual description of requirements.48
9.9 Classifications, coding and dictionaries management activities .49
9.9.1 Textual description of requirements.49
1 Informative Annexe: highlights on ODP.51
2 Informative Annexe: Rationale on the federative structure of the Health Information Systems
architecture .54


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Foreword
This document (prEN 12967-1:2006) has been prepared by Technical Committee CEN/TC 251 "Health
informatics", the secretariat of which is held by NEN.
This document is currently submitted to the CEN Enquiry.
This document will supersede ENV 12967-1:1998.
This three part draft 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 the European prestandard ENV 12967-1: 1997 Medical informatics –
Healthcare Information System Architecture (HISA) - Part 1: Healthcare middleware layer .

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Introduction
Healthcare organisational structure consists of networks of centres (hospital cooperations 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 support effectively 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, organizational and managerial) of the healthcare structure must be
supported by the architecture, that 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 being defined for supporting specific
requirements, both in terms of in situ user operations and with respect to 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:
- to identify a methodology to describe healthcare information systems through a language, notation and
paradigms suitable to facilitate the planning, design and comparison of systems;
- to 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.

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prEN 12967-1:2006 (E)
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ccoommmmoonn e ennteterrpprriissee ddaatata eenndd ccoommmmoonn b buussiinesnesss llooggiicc

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
formalizes only fundamental aspects, identified as common in all European countries and considered to be –
today- essential in any advanced healthcare information system. Specifications are formalized, avoiding any
dependency on specific technological products and/or solutions.
The standard, therefore, is an open framework that -according the specification methodology and preserving the
compatibility with previous versions- can be extended during the time according to the evolution of the healthcare
organisation both in the individual –national and local- contexts and through international standardization
initiatives.
A European pre-standard, ENV 12967-1, was developed according to such rationale during 1993-1997 and has
been the basis for several implementations of middleware products and implemented integrations in healthcare
regions. In year 2000 the CEN/ TC 251 Short Strategic Study: Health Information Infrastructure (2000-08-04) 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 standardisation initiatives have delivered a number of object
oriented domain models and message descriptions that include an architecture for the Electronic Health Record
(ENV 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.
The present EN evolves and refines the ENV 12967-1 pre-standard taking into account the outcomes from its
practical utilisations of 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:
- The architecture is described according to the methodology of ISO/IEC 10746 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.
- The 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 peculiarities
of specific sectors, but provides an overarching comprehensive information and services framework suitable
to accommodate all sectorial requirements.
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- 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.
- In 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.


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 1.1

applications
Scope of the
standard
Middleware of objects
integrating common data and common business logic

Figure 1.1

The architectural principles are formalised according to the ISO/IEC 10746 criteria and are therefore structured
through the following three viewpoints:
a) The 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) The 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) The 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
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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 vendors.
For this exercise it is recommended to follow the methodology formalised by the Engineering and Technology
viewpoints of the ISO ODP Reference model.
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
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies.
prEN 13940-1:2005 Health Informatics – System of concepts to support continuity of care – Part 1: Basic
concepts
EN 14822-1:2005 Health Informatics – General purpose information components – Part 1: Overview
EN 14822-2:2005 Health Informatics – General purpose information components – Part 2: Non Clinical
EN 14822-3:2005 Health Informatics – General purpose information components – Part 3: Clinical
CEN/TS 14796:2004 Health Informatics – Data types
prEN_13606-1 Health informatics – Electronic health record communication – Part 1: Reference
model
prEN_13606-4 Health informatics – Electronic health record communication – Part 4: Security
ENV 12967-1: 1997 Medical Informatics – Healthcare Information System Architecture Part 1 (HISA) –
Healthcare Middleware Layer (to be removed in the end !)
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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
ISO/IEC 15414 Information technology – Open Distributed Processing – Reference model: Enterprise
language
ISO/IEC 19793 Information technology – Open distributed processing – Use of UML for ODP system
specifications
ISO 9000:2000 Quality management systems – Fundamentals and vocabulary


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3 Terms and definitions
For the purposes of this European Standard the following terms and definitions apply.
3.1 System concepts
3.1.1
scope (of a system)
the behaviour the system is expected to exhibit towards the enterprise it serves.
3.1.2
field of application (of a specification)
the properties the environment of the ODP system must have for the specification of that system to be viable
3.1.3
information service
the 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
A viewpoint (on a system) is an abstraction that yields a specification of the whole system related to a particular
set of concerns.
3.2 Concepts relating to organisation
3.2.1
organisation
group of people and facilities with an arrangement of responsibilities, authorities and relationships [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 cooperations 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 peopl
...