SIST ENV 13940:2003
(Main)Health Informatics - System of concepts to support continuity of care
Health Informatics - System of concepts to support continuity of care
Continuity of care implies the management of health information in two different perspectives:
- local management of information about the subject of care, at the site of care provision,
- information interchange between health care providers.
This European pre-standard seeks to identify and define those processes which relate to the continuity of care. It specifically addresses aspects of sharing patient related information needed in the process of care. It identifies and defines relevant data and information flows, together with their relationships to "time slots".
In order to support the delivery of high quality care to each patient, and to facilitate continuity of care, a full understanding is needed of the temporal aspects of the delivery of health care, the role of each party in the health care process , and their interaction in the patient's environment. The concepts describing the characteristics of the ongoing process of care should not differ in nature from those that are used to structure and organise the data locally in the Electronic Health Care Record.
Medizinische Informatik - Begriffssystem zur Unterstützung der Kontinuität der Versorgung
Informatique de santé - Systeme de concepts en appui de la continuité des soins
Zdravstvena informatika – Sistem konceptov za podporo neprekinjeni oskrbi
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST ENV 13940:2003
01-oktober-2003
Zdravstvena informatika – Sistem konceptov za podporo neprekinjeni oskrbi
Health Informatics - System of concepts to support continuity of care
Medizinische Informatik - Begriffssystem zur Unterstützung der Kontinuität der
Versorgung
Informatique de santé - Systeme de concepts en appui de la continuité des soins
Ta slovenski standard je istoveten z: ENV 13940:2001
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST ENV 13940:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN PRESTANDARD
ENV 13940
PRÉNORME EUROPÉENNE
EUROPÄISCHE VORNORM
December 2001
ICS 35.240.80
English version
Health Informatics - System of concepts to support continuity of
care
Informatique de santé - Système de concepts en appui de Medizinische Informatik - Begriffssystem zur Unterstützung
la continuité des soins der Kontinuität der Versorgung
This European Prestandard (ENV) was approved by CEN on 19 October 2000 as a prospective standard for provisional application.
The period of validity of this ENV is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the ENV can be converted into a European Standard.
CEN members are required to announce the existence of this ENV in the same way as for an EN and to make the ENV available promptly
at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the ENV) until the final
decision about the possible conversion of the ENV into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. ENV 13940:2001 E
worldwide for CEN national Members.
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ENV 13940:2001 (E)
Contents
Foreword. 4
Introduction . 5
1. Scope. 6
2. Normative references . 8
3. Definitions . 8
4. Abbreviations . 12
5. Domain description : organisational principles of longitudinal care . 13
6. Actors in Continuity of Care . 14
6.1 Health Care Agent. 14
6.2 Health Care Device . 15
6.3 Health Care Software. 16
6.4 Health Care Party. 17
6.5 Subject of Care . 19
6.6 Health Care Provider. 21
6.7 Health Care Organisation. 23
6.8 Health Care Professional . 25
6.9 Health Care Third Party. 27
6.10 Other Carer . 29
7. Health Issues and their management. 30
7.1 Health Issue . 30
7.2 Health Issue Thread. 32
8. Situations in Continuity of Care. 34
8.1 Period of Service. 34
8.2 Contact. 36
8.2.1 Record Access and Update. 38
8.2.2 Encounter . 40
8.3 Contact Element. 41
8.4 Episode of Care . 43
8.5 Cumulative Episode of Care . 45
9. Concepts related to activity, use of clinical knowledge, and decision support in Continuity of Care . 47
9.1 Clinical Guideline. 47
9.2 Protocol . 48
9.3 Programme of Care . 50
9.4 Care Plan . 52
9.5 Health Care Objective . 54
9.6 Health Care Goal. 55
9.7 Health Care Activity. 56
9.7.1 Health Care Service . 57
9.7.2 Health Care Compliant Activity. 59
9.7.3 Health Care Automated Activity. 60
9.8 Services Bundle . 61
10. Concepts related to responsibility in Continuity of Care . 63
10.1 Mandate . 63
10.1.1 Demand Mandate. 65
10.1.2 Care Mandate. 67
10.1.3 Mandate to Export Personal Data . 69
10.1.4 Continuity Facilitator Mandate . 71
10.2 Demand for Care. 73
10.3 Mandate Notification. 75
11. Health Data Management in Continuity of Care . 77
11.1 Local Health Care Record. 77
11.2 Record Component. 79
11.3 Sharable Data . 80
11.4 Sharable Data Repository . 82
11.5 Specific Clinical Information Request. 84
11.6 Tailored Clinical Information. 85
11.7 Non Validated Clinical Data. 86
11.8 Clinical Data for Import. 87
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ENV 13940:2001 (E)
Annex A (informative) Partial view over a UML representations of the system of concepts . 88
A.1 Actors. 88
A.2 Health Care Services. 89
A.3 Situations and Health Care Services . 90
A.4 Mandates . 91
A.5 Mandates and Health Care Services .92
A.6 Health Care Record . 93
A.7 Health Data Management. 94
Annex B (Informative) Overview and explanatory comments. 95
Annex C (informative) Bibliography . 107
Annex D (Informative) Comparison of several definitions as per this European pre-standard with
corresponding definitions as per previous European standardisation works. 109
Index . 119
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ENV 13940:2001 (E)
Foreword
This European pre-standard has been prepared by CEN Technical Committee 251 "Health
Informatics", under mandate M/255 and order voucher BC/CEN/97/23.1.2 by the European
Commission and the European Free Trade Association.
The normative provisions of this European pre-standard are to be found in Clauses 5 to 11. The
informative Annexs A and B provide further descriptions and explanations, as well as a tentative model
of some parts of the system of concepts that forms the normative clauses, focusing on some details
wherever felt necessary.
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 June 2002, and conflicting national standards shall be
withdrawn at the latest by June 2002.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this European Prestandard : Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
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ENV 13940:2001 (E)
Introduction
There is a need for clinicians, private and public health care providers, health managers and funding
organisations to define 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 the
clinical situation and the 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.
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ENV 13940:2001 (E)
1. Scope
Continuity of care implies the management of health information in two different perspectives:
local management of information about the subject of care, at the site of care provision,
information interchange between health care providers.
This European pre-standard seeks to identify and define those processes which relate to the continuity
of care. It specifically addresses aspects of sharing patient related information needed in the process
of care. It identifies and defines relevant data and information flows, together with their relationships to
"time slots".
In order to support the delivery of high quality care to each patient, and to facilitate continuity of care, a
full understanding is needed of the temporal aspects of the delivery of health care, the role of each
party in the health care process , and their interaction in the patient’s environment. The concepts
describing the characteristics of the ongoing process of care should not differ in nature from those that
are used to structure and organise the data locally in the Electronic Health Care Record.
This European pre-standard addresses such topics as :
organisational principles of longitudinal care
actors : health care agents, health care parties, subjects of care, health care providers, provider
organisations, health care professionals, and third parties
events : health issues, and their management
situations :, contacts, encounters, episodes of care, and periods of service
concepts related to decision support, use of clinical knowledge, and activity : services, protocols,
programmes of care, care plans, care pathways
concepts related to responsibility and information flows within the clinical process : mandates and
their notification
concepts related to health data management
In order to establish a common conceptual framework for continuity of care across national, cultural
and professional barriers, all these concepts are defined in this document, and their inter-relationships
identified.
The system of concepts and the terms defined in this European pre-standard are designed to support
the management of health care related information over time and the delivery of care by different
health care agents 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, health care logistics such as provision of coherent services— and to enhance relationships
between health care professionals and their patients.
Within this European pre-standard, 'subject of care' —a concept definitely restricted here to human
beings— refers to an individual. It is assumed that in those cases where a health care service
addresses a group of more than one individual (e.g. a family, a community, etc.), and where a single
health care record is used to capture the health care services provided to the group, each individual
within the group will be referenced explicitly within that health care record.
This European pre-standard does not intend to define how the processes should be performed in a
particular health care framework. It does not intend to have any regulatory impact on the actual delivery
of care. For example, it defines what "a hospital stay" is, but it does not specify in any way the events
that may occur during a hospital stay.
The specific management of prescriptions for drug therapy and of laboratory tests and their results are
not part of this European pre-standard; nor does the pre-standard define any other aspects of the
health care process, such as security, act specific management, the life cycle of acts, terminology and
classification, or the financing mechanism of health care delivery.
While this European pre-standard can help manage the logistics of health care delivery, it does not
intend to refer specifically to the issue of resources needed in the provision of health care services.
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ENV 13940:2001 (E)
NOTE:
This European pre-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 care record communication. The primary focus of the pre-standard is
terminology.
In order to help the readers understand more easily the relationships between these concepts, several
diagrams have been introduced based on UML conventions. Thus, for each one of the concepts
described in clauses 6 to 11, a diagram is provided, showing its direct relationships with other concepts
belonging to the same system of concepts.
The concept under consideration appears at the centre of these diagrams. This decision has been
made to improve clarity and to show the relationships in one direction only, with corresponding
cardinalities.
The purpose of UML modelling in this documents is to highlight relationships of concepts, not their
attributes. Features which refer to some entities may be considered as related concepts in their own
right. Because of the generic nature of some of these features, they may not belong to the system of
concepts that forms the scope of this European pre-standard, and in that case such features will not be
described further. An example of this is:
a subject of care may have an undefined number of addresses, and an address may be associated
with an undefined number of subjects of care. The resolution of this many to many relationship is
not within the scope of this pre-standard.
In order to differentiate them both from normal attributes and from concepts with which direct
relationships are explicitly mentioned, these features are shown apart, in a rubric called "Other features
or related entities not described in this document".
Diagrams meant to provide partial views of the system of concepts are also proposed in Annex A.
These diagrams have been simplified on purpose: they do not show all the relationships between the
concepts that are displayed, while the relationships that are present bear their cardinalities only.
It is acknowledged that in doing so, some distance is consciously taken with the basic UML
conventions.
The same pattern of rubrics is systematically provided for the description of all concepts presented in
clauses 6 to 11. Whenever not felt relevant to a given concept, these rubrics are intentionally left blank.
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.
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ENV 13940:2001 (E)
2. Normative references
This European pre-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 below. For dated references, subsequent amendments to or revisions of any of
these publications apply to this European pre-standard only when incorporated in it by amendment or
revision. For undated references the latest edition of the publication referred to applies.
ISO 6523:1984 Data inter change — Structure for the identification of organisations
ISO/DIS 10241:1992 Inter national Terminology Standards
Preparation and Layout
(currently under revision)
ISO/CD 1087- 1:1994 T erminology — Vocabulary
ENV 1613:1995 Medic al Informatics — Messages for exchange of laboratory information.
ENV 12264:1997 Medic al Informatics — Categorial Structures of System of Concepts —
Model for the Representation of Semantics
ENV 12265:1997 Medic al Informatics — Electronic health care record architecture
ENV 12381:1996 Medic al Informatics — Time Standards for Health Care Specific Problems
ENV 12017:1997 Medic al Informatics — Medical Informatics Vocabulary
ENV 12967-1:1998 Medic al Informatics — Health Care Information System Architecture
Part 1: Health Care Middleware Layer
ENV 13606-1:2000 Health Inf ormatics — Electronic Health Care Record Communication
Part 1: Extended Health Care Record Architecture
ENV 13606-2:2000 Health Inf ormatics — Electronic Health Care Record Communication
Part 2: Domain Term List
ENV 13606-3:2000 Health Inf ormatics — Electronic Health Care Record Communication
Part 3: Distribution Rules
ENV 13606-4:2000 Health Inf ormatics — Electronic Health Care Record Communication
Part 4: Messages for the Exchange of
3. Definitions
For the purposes of this European pre-standard, the following definitions (listed in alphabetical order)
apply.
3.1 Care Mandate : mandate assigned to one health care party to perform health care services for
a subject of care, as well as to manage locally the information related to the health of that subject of
care.
3.2 Care Plan : description of planned and duly personalised services bundles, addressing one or
more health issues, and encompassing all health care services to be provided to a subject of care by
one health care professional.
3.3 Clinical Data for Import : record component that is candidate for import into the health care
record held locally by a health care party after a health care professional has validated its clinical
relevance.
3.4 Clinical Guidelines : set of systematically developed statements to assist the decision of
health care parties about health care services to be provided with regard to a health issue in specified
clinical circumstances.
3.5 Concept : unit of thought constituted through abstraction on the basis of properties common to
a set of one or more referents. [ENV 12264:1997] [ISO CD 1087-1:1994]
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ENV 13940:2001 (E)
3.6 Contact : situation on the uninterrupted course of which one health care provider performs
health care services for a subject of care, and/ or accesses his or her health care record.
3.7 Contact Element : part of a contact that specifically addresses one and only one health issue.
3.8 Continuity Facilitator Mandate : mandate assigned to one health care agent on behalf of a
subject of care to monitor how the successive care mandates are handled, and keep their contents at
the disposal of authorised health care agents, as well as to manage generally the information related to
this subject's of care health.
3.9 Cumulative Episode of Care : situation encompassing the occurrence of all health care
services related to only one health issue thread.
3.10 Definition : statement that describes a concept in order to permit its differentiation from
related concepts. [ENV 12264:1997]
3.11 Distribution rule : logical concept or rule intended to convey and govern distribution. [ENV
13606-3:1999]
3.12 Demand for Care : demand expressed by a health care party that health care services be
provided to a subject of care.
mandate assigned to one or more health care parties to act on behalf of a
3.13 Demand Mandate :
subject of care in demanding that those health care services that are relevant with regard to a
perceived need for care be delivered.
3.14 Deprecated term : term rejected by an authoritative body [ISO CD 1087-1:1994]
3.15 Electronic Health Care Record : health care record in computer readable form. [ENV 13606-
1 & 4]
3.16 Encounter, Patient Contact : situation on the uninterrupted course of which one health care
professional delivers health care services to a subject of care, and accesses his or her health care
record, and updates it.
3.17 Episode [time] : situation considered to occupy a time interval. [ENV 12381:1996]
3.18 Episode [continuity of care], Episode of Care : situation encompassing all contact elements
related to the same health issue.
3.19 Event : situation considered to occur at a time point. [ENV 12381:1996]
3.20 Health Care : provision of health related services.
NOTE : This includes more than performing procedures on subjects of care. It includes also,
for example, the management of the information about patients, their health status and their
relations within the health care framework.
NOTE : In the present European pre-standard, the term 'care' may be used as a synonym for
'health care'.
3.21 Health Care Activity : activity performed for a subject of care by a health care agent with the
intention of directly or indirectly improving or maintaining the health of that subject of care.
3.22 Health Care Agent : person, organisation, device, or software that performs a role in a health
care activity. [ENV 13606-4, modified]
activity performed for a subject of care by a health care
3.23 Health Care Automated Activity :
device or a health care software, without an immediate command being given by a health care
professional.
3.24 Health Care Compliant Activity : activity performed for a subject of care by any other health
care party than a health care provider.
3.25 Health Care Device : device or equipment used in the provision of health care services. [ENV
13606-4, modified]
3.26 Health Care Goal : desired achievement of a care plan, considered as an intermediate
operational step to reach the ultimate objective of a programme of care.
3.27 Health Care Objective : desired ultimate achievement of a programme of care.
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ENV 13940:2001 (E)
3.28 Health Care Organisation : organisation involved in the direct provision of health care
services. [ENV 13606-4, modified] [ENV 1613:1995, modified]
3.29 Health Care Party : organisation or person involved in the process of health care. [ENV
13606-4, modified] [ENV 1613:1995, modified]
3.30 Health Care Professional : person involved in the direct provision of health care services.
[ENV 1613:1995, modified]
3.31 Health Care Provider : health care professional or health care organisation involved in the
direct provision of health care services.
3.32 Health Care Record : repository of information regarding the health of a subject of care. [ENV
12265] [ENV 13606-1 & 4]
activity performed for a subject of care by a health care provider with
3.33 Health Care Service :
the intention of directly or indirectly improving or maintaining the health of that subject of care. [ENV
13606-4, modified] [ENV 1613:1995, modified]
3.34 Health Care Software : software used in the provision of health care services. [ENV 13606-4,
modified]
party involved in supporting health care services, financially or
3.35 Health Care Third Party :
practically.
3.36 Health Issue : issue related to the health of a subject of care, as defined by a specific health
care party.
3.37 Health Issue Thread : abstract construct linking several health issues, defined by a health
care party.
3.38 Local Health Care Record : health care record held and maintained for a subject of care by a
health care party.
3.39 Mandate : set of statements explicitly or implicitly defining the scope and limits of the accepted
specific role of a health care party, and explicitly or implicitly delineating
...
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