Health informatics - System of concepts to support continuity of care - Part 2: Health care process and workflow

The purpose of this European Standard is to enable communication at the semantic level between information systems in health care. This part standard complements Part 1. Its specific purpose is to define a system of concepts enabling the management, including communication, of the necessary information about the core process of health care provision to an individual subject of care and the corresponding workflow, so as to support its continuity, taking into consideration decision processes, quality control, and resource management. It provides the terminology for planning, delivery and follow-up of those activities that form the overall process.
This part standard applies a process modelling technique to identify the process objects, activities and sub-processes. It also takes into consideration the resource aspects, the responsibilities of health care providers, and means for patients' participation. Whenever continuity of health care delivery implies social interventions as part of, or in support to, the process towards health recovery, these are to be mentioned wherever relevant in the process and workflow; but addressing those social interventions in depth is not part of the scope of this European Standard.

Medizinische Informatik - Begriffssystem zur Unterstützung der Versorgungskontinuität - Teil 2: Gesundheitsfürsorge-Prozess und Arbeitsablauf

Informatique de la santé - Système de concepts en appui de la continuité des soins - Partie 2: Processus de soins et flux des tâches

1.1 Objet principal
La présente partie de l'EN 13940 vient en complément de la partie 1 (EN 13940-1). En particulier, elle vise à
définir un système de concepts pour l’administration des soins dans les processus cliniques pour un sujet de
soins individuel et pour le flux des tâches correspondant, qui permettra de faciliter la gestion, notamment la
communication, afin de renforcer la continuité des soins, en tenant compte du traitement des données, de la
prise de décision, du contrôle qualité et de la gestion des ressources. Elle fournit toute la terminologie
relative à la planification, à l’administration et au suivi des activités, ainsi que celle relative aux conditions de
santé qui forment le processus clinique et de soins de santé global. Elle vise également à permettre la
réutilisation des données cliniques à d’autres fins que les soins directs d’un sujet de soins individuel au
niveau du groupe pour le suivi et la gestion des connaissances.
La présente partie identifie les objets les plus communs, traités et identifiables dans des processus cliniques.
Elle prend également compte de l’aspect ressources, des responsabilités des prestataires de soins et a un
intérêt dans la participation du sujet de soins. Lorsque la continuité de l’administration des soins de santé
implique une intervention sociale comme faisant partie de ou venant étayer le processus de soins pour
recouvrer la santé, ceux-ci doivent être mentionnés, le cas échéant, dans les descriptions du processus et
du flux des tâches, mais la présentation approfondie de ces interventions sociales n'est pas couverte par le
domaine d’application de la présente Norme européenne.

Zdravstvena informatika - Sistem pojmov za podporo neprekinjeni oskrbi - 2. del: Proces zdravstvene oskrbe in potek dela

General Information

Status
Not Published
Public Enquiry End Date
02-Jan-2011
Technical Committee
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
22-Oct-2010
Due Date
11-Mar-2011
Completion Date
18-Jan-2011

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SLOVENSKI STANDARD
oSIST prEN 13940-2:2010
01-december-2010
Zdravstvena informatika - Sistem pojmov za podporo neprekinjeni oskrbi - 2. del:
Proces zdravstevene oskrbe in potek dela
Health informatics - System of concepts to support continuity of care - Part 2: Health care
process and workflow
Medizinische Informatik - Begriffssystem zur Unterstützung der Versorgungskontinuität -
Teil 2: Gesundheitsfürsorge-Prozess und Arbeitsablauf
Informatique de la santé - Système de concepts en appui de la continuité des soins -
Partie 2: Processus de soins et flux des tâches
Ta slovenski standard je istoveten z: prEN 13940-2
ICS:
01.040.35 Informacijska tehnologija. Information technology.
Pisarniški stroji (Slovarji) Office machines
(Vocabularies)
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN 13940-2:2010 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 13940-2:2010

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oSIST prEN 13940-2:2010


EUROPEAN STANDARD
DRAFT
prEN 13940-2
NORME EUROPÉENNE

EUROPÄISCHE NORM

October 2010
ICS 01.040.35; 35.240.80
English Version
Health informatics - System of concepts to support continuity of
care - Part 2: Health care process and workflow
Informatique de la santé - Système de concepts en appui Medizinische Informatik - Begriffssystem zur Unterstützung
de la continuité des soins - Partie 2: Processus de soins et der Versorgungskontinuität - Teil 2: Gesundheitsfürsorge-
flux des tâches Prozess und Arbeitsablauf
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 CEN 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.

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: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 13940-2:2010: E
worldwide for CEN national Members.

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Contents Page
Foreword . 5
0 Introduction . 5
0.1 General . 5
0.2 Target groups . 5
0.3 Health . 6
0.4 Notes . 7
1 Scope . 9
1.1 Main purpose . 9
1.2 Topics outside the scope . 9
2 Conformance . 9
2.1 Full conformance . 9
2.2 Partial conformance . 10
3 Normative references . 10
4 Terms and definitions . 10
5 Symbols and abbreviations . 13
6 Introduction and explanatory comments . 14
6.1 Process and workflow . 14
6.2 Different types of processes in health care organisations . 15
6.3 Workflow and information needs in health care . 17
6.4 Life cycle in health care processes . 17
6.5 Inputs and outputs in the health care process . 18
6.6 Concepts related to the transformation of the object processed in a health care process . 18
6.7 Aspects on clinical processes . 19
7 Concepts related to health . 21
7.1 Health state . 22
7.2 Health condition . 24
8 Process related concepts . 25
8.1 Health care process. 26
8.2 Clinical process . 28
8.3 Health care quality management . 29
8.4 Health care resources management . 30
8.5 Health care administration . 31
8.6 Health care resource . 32
9 Health care workflow descriptive items . 34
9.1 Health care workflow . 35
9.2 Adverse event . 37
9.3 Adverse event handling . 38
9.4 Need for health care . 39
9.5 Initial contact . 40
9.6 Demand for initial contact . 41
9.7 Referral . 42
9.8 Request . 43
9.9 Health care appointment . 44
9.10 Health care commitment . 45
10 Concepts related to workflow . 46
10.1 Clinical pathway . 47
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10.2 Health care investigating activity . 48
10.3 Health care treatment activity . 49
10.4 Health care activities repository . 50
11 Data and information management . 51
11.1 Discharge report . 52
11.2 Discharge summary . 53
12 Concepts related to process evaluation . 54
12.1 Health care process evaluation . 55
Annex A (informative) Examples of process modelling . 57
A.1 The Danish EHR Model . 57
A.2 The SAMBA Model . 58
A.3 The Nursing Process Model . 59
A.4 The Swedish Generic Process Model for Health Care . 60
Annex B (informative) Contextual framework for traceability of concepts in this standard . 61
B.1 Introduction . 61
B.2 Strategy for traceability of concepts . 61
B.3 The generic clinical process model . 62
B.4 The workflow model based on the generic clinical process . 64
B.5 Information areas for concepts to be identified . 70
Annex C (normative) Terms defined in Part 1 of this European standard (EN 13940 1:2007) . 72
Bibliography . 77

Table of Figures
Figure 1 ― General schematic representation of a process, with inputs, nested activities/processes,
management, resource supply and outputs, at different levels of detail . 14
Figure 2 ― Information areas and the relation between clinical process and other areas . 17
Figure 3 ― Comprehensive UML diagram of concepts related to health . 21
Figure 4 ― Health state (UML representation). 23
Figure 5 ― Health condition (UML representation) . 25
Figure 6 ― Comprehensive UML diagram of process related concepts . 25
Figure 7 ― Health care process (UML representation) . 27
Figure 8 ― Clinical process (UML representation) . 28
Figure 9 ― Health care quality management (UML representation) . 29
Figure 10 ― Health care resources management (UML representation) . 30
Figure 11 ― Health care administration (UML representation) . 31
Figure 12 ― Health care resources (UML representation) . 32
Figure 13 ― Point of care (UML representation) . 33
Figure 14 ― Comprehensive UML diagram of health care workflow descriptive items . 34
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Figure 15 ― Health care workflow (UML representation) . 36
Figure 16 ― Adverse event (UML representation) . 38
Figure 17 ― Adverse event handling (UML representation) . 38
Figure 18 ― Need for health care (UML representation) . 39
Figure 19 ― Initial contact (UML representation) . 40
Figure 20 ― Demand for initial contact (UML representation) . 41
Figure 21 ― Referral (UML representation) . 42
Figure 22 ― Request (UML representation) . 43
Figure 23 ― Health care appointment (UML representation) . 44
Figure 24 ― Health care commitment (UML representation) . 45
Figure 25 ― Comprehensive UML diagram of concepts related to workflow . 46
Figure 26 ― Clinical pathway (UML representation) . 47
Figure 27 ― Health care investigating activity (UML representation) . 48
Figure 28 ― Health care treatment activity (UML representation) . 49
Figure 29 ― Health care activities repository (UML representation) . 50
Figure 30 ― Comprehensive UML diagram of data and information management . 51
Figure 31 ― Discharge report (UML representation) . 52
Figure 32 ― Discharge summary (UML representation) . 53
Figure 33 ― Comprehensive UML diagram of concepts related to process evaluation . 54
Figure 34 ― Health care process evaluation (UML representation) . 55
Figure 35 ― Clinical process outcome evaluation (UML representation) . 56

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Foreword
This document (prEN 13940-2:2010) 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.
The two-part standard 13940 under the general heading Health informatics – System of concepts to support
Continuity of care" consists of the following parts:
Part 1: Basic concepts.
Part 2: Health care process and workflow.
0 Introduction
0.1 General
Continuity of care is increasingly invoked nowadays as one of the most important issues in health care. What
is in perspective is both an improvement of the quality of care, and a reduction of costs. Continuity of care is
now seen as prerequisite to improve at the same time efficacy, effectiveness and efficiency of health care.
Thus there is a need for clinicians, private and public health care providers, health managers, and funding
organisations to base their decisions, in terms of re-organisation of services, on a good understanding of the
concepts involved.
This European Standard defines the classes of concepts and their descriptive terms, regarding all processes
of care, especially considering patient-centred continuity of care, shared care and seamless care.
Continuity of care depends on the effective transfer and linkage of data and information about both the
clinical situation and the health care provided to a subject of care, between different parties involved in the
process, within the framework of ethical, professional and legal rules. The description and formalisation of
continuity of care in information systems implies that the related concepts and descriptive terms be defined,
so establishing a common conceptual framework across national, cultural and professional barriers.
This part standard defines a set of concepts reflecting phenomena that are basically part of the processes in
health care concerning an individual subject of care. The health care process reflects the interaction between
the subject of care and health care professionals in general. The clinical process is defined by a clinical
context to cover the continuity aspects from the subject of care perspective. The actual focus of that process
is the health state of a subject of care. This document focuses the concepts related to the health care and
the clinical processes as well as the workflow of the clinical process. This second part of the two-part
standard supplements the first part from this perspective. With the aim to further clarify and give traceability
to the concepts, this document also includes an informative part with generic models of the clinical process
and the workflow of that process.
0.2 Target groups
The system of concepts and the terms defined in this European Standard are designed to support the
management of health care related information over time and the delivery of care by different health care
actors who are working together. This includes primary care professionals and teams, health care funding
organisations, managers, patients, secondary and tertiary health care providers, and community care teams.
This harmonised system of concepts will be used to facilitate clinical and administrative decision making, and
to enhance relationships between health care professionals and their patients.
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Among other applications, the content of this European Standard should have importance for the
development of well designed clinical networks, either at regional — possibly cross-border —, or at local
level, either including hospital settings or not; it will help the correct management of personal health data. It
provides a clear conceptual framework to establish the terms of reference of health information systems, to
be used for tenders.
The system of concept as well as the process and workflow descriptions are meant as tools for the
development of information systems. They may also be used for business analysis as a basis for
organisational decisions and more widely in organisational developments that are not inherently tied to the
use of ICT.
0.3 Health
In 1948 WHO defined health as “. a state of complete physical, mental and social well-being and not merely
the absence of disease or infirmity”. We interpret this definition as being the one of 'good health', which
means that any harm to the physical, mental or social condition of a person has the effect that health is no
longer present. This definition by WHO does not include any incompleteness of "health", meaning that the
presence of any disease or (health) problem, calling or not for health care activities causes the subject of
care not to possess health. To our eyes, WHO defines something that most people would consider to be
"good health" or even "best possible health", the ultimate target for any intervention meant to restore,
maintain or stabilise an individual's or a population's welfare. In 1986 WHO made two amendments to the
above definition: “resource for everyday life, not the objective of living”, and “health is a positive concept
emphasising social and personal resources, as well as physical capacities”. Thus health still includes several
quality perspectives and is not just inherent characteristics of an individual.
In ICF (the International Classification of Functioning, Disability and Health) of WHO, the concept of health is
described in a more specified way. The theoretical model in ICF identifies five health components; body
function, body structure, activity and participation, personal and environmental factors respectively. And it is
noteworthy that in the introduction of an article published on Saturday 22 March 2003 in the Health Care
Financing Review1, Tevfik Bedirhan Üstün et al. also write: "The health state of a person can be described in
terms of capacity to carry out a set of tasks or actions. In addition, the health state also includes changes in
body functions and/or structures arising from a health condition. The impact of the health state on a person's
life can be understood by measuring performance of tasks and actions in the person's real-life or actual
environment. The full picture of the health experience can further be appreciated by taking into cognisance
the value that people place on levels of functioning in given domains in association with a health condition.
Plainly, the concept of functional status is integral to health and its achievement. Two individuals with
identical diagnoses may have utterly different levels of functioning that determine their actual health status."
In this European Standard, the word “health” is not used as an isolated term designating any concept within
the scope of the standard. The word "health" is merely used as prefix in several terms. The meaning of this
prefix is that the concept represented by the term has to do with the subject's of care health state or health
condition, often in relation to a health care/clinical process. To describe, for example, a body function, a
mental state, a degree of general well-being, and causes for interventions in the domain of health care, this
European Standard uses the terms "health state", "health condition" and "health issue". The health state is a
concept reflecting a holistic view of the health of a human being. The health condition is a perception of an
aspect or part of the health state and it may be good or bad. The health issue is the reason for the request
for health care and it may or may not encompass a disease but it is always subject to assessment with
respect to whether health care activities are needed, including medical statements, immunisation and other
activities performed for a person in good health state.

1
"WHO's ICF and functional status information in health records", Health Care Financ Rev. 2003 Spring;24(3):77-88.
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0.4 Notes
0.4.1 General
These notes apply to this European Standard in general.
0.4.2 Subject of care
In this European Standard, 'subject of care' refers to an individual. It is assumed that in those cases where a
health care activity addresses a group of more than one individual (e.g. a family, a community), and where a
single health record is used to capture the health care activities provided to the group, each individual within
the group will be referenced explicitly within that health record.
0.4.3 Health care versus social care
Health care as well as social care has the objective to restore, maintain, and keep health in the WHO sense.
Health care is not limited to clinical activities with influence on body function or body structure. All kinds of
activities having the potential to influence any one of the five components of health mentioned in ICF can be
part of health care. Activities interacting with intellectual functions may have the purpose to improve the
health state; such activities include informative and supportive talk as well as psychotherapy. Provision of a
walking cane may be an act of rehabilitation and is considered to be within the scope of health care. In social
care oral information as well as provision of physical aid may contribute to the restoration of health. There is
an obvious overlap between health care activities and social care activities. This standard is focussed on the
part of health care that does not include social care. The role of the subject of care is defined out from that
health care domain and the terms chosen are from that sector. However many of the concepts are relevant
for the social care sector and in the cooperation of the different domains of health care this standard should
be applicable, though it is not the primary aim of this standard to directly be applied in social care.
0.4.4 Description and display of concepts
This European Standard aims to identify and describe concepts important to continuity of care, and to
establish a system of concepts that is to be used when setting up information systems, especially when
dealing with health record communication. The primary focus of the standard is terminology and ontology.
Descriptions framed in tables having the same pattern of rubrics are systematically provided for all the
concepts presented in Clauses 7 to 12. Whenever not felt relevant to a given concept, some of these rubrics
may intentionally be left blank. In the headings of these tables, the names of those concepts that are purely
abstract constructs and therefore are not instantiable but through their specialisation, are shown in italic
characters.
Examples are provided wherever felt relevant and necessary. However, in general, examples for
superordinate concepts are to be sought at the level of the corresponding subordinate concepts.
In order to help the readers understand more easily the relationships between these concepts, diagrams
have been introduced based on UML conventions. Thus, for each one of the concepts described in Clauses
6 to 11, a subset of the general and comprehensive diagram is provided as an illustrative part of the
monograph, showing only its
...

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