SIST EN ISO 12967-1:2021

SLOVENSKI STANDARD
oSIST prEN ISO 12967-1:2019
01-december-2019
Zdravstvena informatika - Arhitektura storitve - 1. del: Podjetniški vidik (ISO/DIS
12967-1:2019)
Health informatics - Service architecture (HISA) - Part 1: Enterprise viewpoint (ISO/DIS
12967-1:2019)
Medizinische Informatik - Servicearchitektur - Teil 1: Unternehmenssicht (ISO/DIS 12967
-1:2019)
Informatique de santé - Architecture de service - Partie 1: Point de vue d'entreprise
(ISO/DIS 12967-1:2019)
Ta slovenski standard je istoveten z: prEN ISO 12967-1
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 12967-1:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 12967-1:2019

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oSIST prEN ISO 12967-1:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 12967-1
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-11-01 2020-01-24
Health informatics — Service architecture (HISA) —
Part 1:
Enterprise viewpoint
Informatique de santé — Architecture de service —
Partie 1: Point de vue d'entreprise
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
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STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 12967-1:2019(E)
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. ISO 2019

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oSIST prEN ISO 12967-1:2019
ISO/DIS 12967-1:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2019 – All rights reserved

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oSIST prEN ISO 12967-1:2019
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Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
3.1 Healthcare . 2
3.2 System concepts . 3
3.3 Concepts relating to organization . 4
3.4 Community concepts . 5
3.5 Behaviour concepts . 5
3.6 Policy concepts . 8
3.7 Accountability, responsibility and time concepts . 8
3.8 Information Management .10
4 Symbols and abbreviations .11
5 Methodology for the specification of the architecture .11
5.1 Viewpoints for the specification of the architecture .12
5.2 The HISA specification procedure .13
5.2.1 The Strategic Paradigm .13
5.2.2 Specification of the enterprise viewpoint .13
5.2.3 Specification of the information viewpoint .14
5.2.4 Specification of the computational viewpoint.14
5.3 Iterative specification .15
5.4 Viewpoints specification languages, notations and levels of abstraction .15
6 HISA overview.17
6.1 General requirement .17
6.2 Enterprise viewpoint .17
6.3 Information viewpoint .19
6.4 Computational viewpoint .19
7 Methodology for extensions .20
8 Conformance criteria .21
8.1 Conformance of specification documents to the HISA methodology .21
8.2 Conformance of middleware products to the HISA architectural requirements .21
9 The HISA Enterprise viewpoint .22
9.1 Introduction(informative) .22
9.1.1 General.22
9.1.2 The regional, inter-enterprise perspective .22
9.1.3 The medical/clinical perspective .23
9.1.4 The operational/clinical and organizational process model perspective .25
9.1.5 The information services and their complexity .28
9.2 The fundamental workflows and groups of users’ activities to be supported by the
middleware .29
9.3 General information requirements for all users’ activities .30
9.3.1 Introduction .30
9.3.2 Common attributes .30
9.3.3 Extensibility .31
9.3.4 Versioning .31
9.3.5 Auditing .31
9.3.6 Handling of life cycle.32
9.4 Subject of care workflow .32
9.4.1 Textual description of requirements .32
9.4.2 Use-case examples (informative) .34
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9.5 Healthcare information workflow .39
9.5.1 Textual specification of requirements .39
9.5.2 Use-case examples (informative) .40
9.6 Healthcare activity management workflow .41
9.6.1 Textual description of requirements .41
9.6.2 Use-case examples (informative) .44
9.7 Resources management activities/Textual description of requirements .47
9.8 Management activities for users and authorizations / textual description of
requirements .48
9.9 Classifications, coding and dictionaries management activities / textual
description of requirements . .49
9.9.1 Examples of Functions from ISO 10781 Health Informatics – HL7
Electronic Health Records-System Functional Model, Release 2 (EHR FM),
providing support .51
Annex A (informative) Highlights of Open Distributed Processing (ODP) .53
Annex B (informative) Rationale for the federative structure of the Health Informatics
Service Architecture .56
Annex C (informative) Cross-Domain Interoperability .59
Bibliography .67
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oSIST prEN ISO 12967-1:2019
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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
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www .iso .org/iso/foreword .html.
The committee responsible for this document is ISO/TC 215, Health informatics.
This second edition is a revision of, cancels and replaces the first edition (ISO 12967-1:2009), which was
based on the European Standard EN 12967-1:2007.
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
The main changes compared to the previous edition of this part (part 1, enterprise viewpoint) are as
follows:
— Use of terms, definitions and concepts from ISO 1390:2016 (Contsys), with textual alignment
throughout the document including figures, to the extent possible and beneficial
— Reference to further standards, such as HL7 and FHIR
— Addition of abstraction layers supplementing the viewpoint descriptions
— Substantial updating (based on ISO 13940:2016 Contsys) regarding text and figures related to the
clinical process, modelling of healthcare and the strategic paradigm of HISA
— Introduction of example Functions from ISO 10781 Health Informatics – HL7 Electronic Health
Records-System Functional Model, supporting the use case examples of the EV
— Addition of Annex C, Cross-Domain Interoperability, in line with the current (2019) ongoing ISO
Interoperability Reference Architecture standardization initiative
— Updates to the Bibliography
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Introduction
The healthcare organizational structure consists of networks of centres (hospitals of different
types and sizes and outpatient clinics for primary and secondary care within a geographical area)
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.
A further aspect is related to quality management (see bibliography), where information management
is an integrated part of quality management and the strategic and operative approaches for these two
managerial aspects need to be co-ordinated to be effective. Clinical processes are comprehensive.
Systematic and structured information management including medical knowledge management is
required for high-level quality in effective healthcare systems.
The aims 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 e.g. 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
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— 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.
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.
In line with the above, HISA neither explicitly addresses major trends within healthcare in 2018
such as "Patient Engagement" or "Patient Registries / Patient Data Hubs". HISA never the less also
supports these trends and might very well be used in connection herewith, providing further support
for information exchange, to the benefit of the patient, or for structured and systematic information
management regarding research, clinical databases, knowledge application and quality improvement.
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, ENV12967-1, 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), and
a concept model of healthcare (ISO 13940). In the last ten years ISO, HL7 and CEN have increasingly
collaborated and both 13606 and 13940 have undergone major systematic reviews as ISO standards.
Besides these ISO standards, HL7 Service-Aware Interoperability Framework (SAIF) has served as a
source of inspiration, the Australian E-health Interoperability Framework (eHIF, see bibliography) and
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a conference paper from 2016 "Digital Health Interoperability Frameworks: Use of RM-ODP Standards"
as sources of input for this revision (see bibliography).
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, currently
serving as the basis for this revision.
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.
— The architecture is intrinsically compatible, complementary and synergistic with other models
and standards, such as HL7 CDA, FHIR, ISO 13940 (Contsys) and the Electronic Health Record
Architecture ISO 13606. A separate mapping document between this HISA standard and HL7 RIM
was produced during the process for the first version of this ISO standard. 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 concepts and principles shared with ISO 13606, ISO 13940 (Contsys) and this standard
are aligned, originally stemming from CEN. But as the standards also reflect different, although
complementary, scopes, purposes and objectives, as investigated during a joint "concurrent use"
initiative, differences do exist.
ISO 12967 consists of three parts:
— Part1 (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 reserve 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 d
...