EN 14822-3:2005
(Main)Health informatics - General purpose information components - Part 3: Clinical
Health informatics - General purpose information components - Part 3: Clinical
This European Standard specifies the definition and structuring of information relating to entities that are commonly encountered in communications with and between clinical information computer systems.
Within the scope of this European Standard is a description of components and their use. In particular, these components relate to the following sub-domains:
- Analysable objects: including samples, body parts, x-rays and other study products, together with their collection and properties.
- Clinical information: including observations, patient conditions, procedures, medication treatment, investigations, counselling plus how these items are organised within a record.
- Medicinal products: including appliances, dosage regimes,etc.
- Routing aspects of medication treatment or other procedures.
Care Service information: including referrals for care services, care encounter information and scheduling.
Medizinische Informatik - Allgemein verwendbare Informationskomponenten - Teil 3: Klinische Informationen
Informatique de la santé - Composants d'information d'usage général - Partie 3 : Informations médicales
La présente Norme européenne spécifie la définition et la structure des informations relatives aux entités que l’on trouve communément dans les communications avec les systèmes informatiques d'informations médicales et entre eux.
La présente Norme européenne comporte un descriptif des composants et de leur utilisation. Ces composants concernent en particulier les sous-domaines suivants :
Objets analysables : comprend les échantillons, les organes, les rayons X et autres produits d’étude, de même que leurs ensembles et caractéristiques.
Informations médicales : comprend les observations, l’état du patient, les procédures, les traitements thérapeutiques, les investigations, le conseil, plus l’organisation de ces éléments dans un dossier.
Produits médicaux : comprend les appareils, les posologies, etc.
Aspects du traitement médicamenteux ou des autres procédures.
Informations sur le service de soins : comprend les orientations vers les services de soins, les informations et la planification des consultations.
Zdravstvena informatika – Informacijske komponente za splošno uporabo – 3. del: Klinični podatki
General Information
- Status
- Published
- Publication Date
- 18-Oct-2005
- Withdrawal Date
- 29-Apr-2006
- Technical Committee
- CEN/TC 251 - Medical informatics
- Drafting Committee
- CEN/TC 251/WG 1 - Information models
- Current Stage
- 9020 - Submission to 2 Year Review Enquiry - Review Enquiry
- Start Date
- 15-Oct-2025
- Completion Date
- 15-Oct-2025
Relations
- Effective Date
- 28-Jan-2026
Overview
EN 14822-3:2005 - Health informatics: General purpose information components - Part 3: Clinical (CEN) defines the clinical set of reusable information components used in communications between clinical information systems. Approved by CEN in 2005, this European Standard specifies definitions, structure and usage guidance for entities commonly exchanged in electronic health records (EHRs), laboratory systems and other clinical IT systems.
Key topics and technical requirements
- Definition and structuring of GPICs: Provides a coherent set of General Purpose Information Components (GPICs) for clinical domains, with formal class-like components and relationships.
- Sub-domain component coverage: Includes components for:
- Analysable objects (specimens, body parts, imaging/study products, collection and properties)
- Clinical information (observations, patient conditions, procedures, medications, investigations, counselling and record organization)
- Medicinal products (appliances, dosage regimes, packs, ingredients)
- Routing and treatment flow (routing options, devices, treatment pathways)
- Care service information (referrals, care encounters, scheduling, service requests/reports)
- Rules for use and context: Contains rules governing GPIC usage, context inheritance for acts, participation and act relationships - important for modelling clinical events and workflows.
- Structural vocabularies: Standardizes vocabularies for act class, mood, status and relationships to ensure consistent semantics across implementations.
- Supplementary guidance: Annexes cover rationale, how to read the models, mapping to Health Level 7 (HL7) reference information model, common features and localisation guidance.
- Identifiers note: Component identifiers in the document are unique within the standard (informative for implementers).
Applications and who should use it
- EHR and HIS vendors - to design interoperable clinical data models and message structures.
- Laboratory and diagnostic system developers - for specimen, investigation and result modelling.
- Pharmacy / medication management systems - for modelling medicinal products, dosing and supply.
- Clinical informaticians & architects - to align record structure, act context and clinical workflows.
- Health IT integrators & standards mappers - for mapping between national/local systems and HL7/other standards.
- Regulators & procurement - when specifying interoperability requirements for clinical applications.
Related standards
- Part of a multipart CEN standard series:
- EN 14822-1: Overview
- EN 14822-2: Non-clinical
- Annex C provides mapping guidance to HL7 reference information model, facilitating integration with existing message standards.
Keywords: EN 14822-3:2005, health informatics, general purpose information components, clinical information, CEN, EHR interoperability, specimen modelling, medication data model.
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Frequently Asked Questions
EN 14822-3:2005 is a standard published by the European Committee for Standardization (CEN). Its full title is "Health informatics - General purpose information components - Part 3: Clinical". This standard covers: This European Standard specifies the definition and structuring of information relating to entities that are commonly encountered in communications with and between clinical information computer systems. Within the scope of this European Standard is a description of components and their use. In particular, these components relate to the following sub-domains: - Analysable objects: including samples, body parts, x-rays and other study products, together with their collection and properties. - Clinical information: including observations, patient conditions, procedures, medication treatment, investigations, counselling plus how these items are organised within a record. - Medicinal products: including appliances, dosage regimes,etc. - Routing aspects of medication treatment or other procedures. Care Service information: including referrals for care services, care encounter information and scheduling.
This European Standard specifies the definition and structuring of information relating to entities that are commonly encountered in communications with and between clinical information computer systems. Within the scope of this European Standard is a description of components and their use. In particular, these components relate to the following sub-domains: - Analysable objects: including samples, body parts, x-rays and other study products, together with their collection and properties. - Clinical information: including observations, patient conditions, procedures, medication treatment, investigations, counselling plus how these items are organised within a record. - Medicinal products: including appliances, dosage regimes,etc. - Routing aspects of medication treatment or other procedures. Care Service information: including referrals for care services, care encounter information and scheduling.
EN 14822-3:2005 is classified under the following ICS (International Classification for Standards) categories: 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 14822-3:2005 has the following relationships with other standards: It is inter standard links to EN 13940-1:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 14822-3:2005 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2006
=GUDYVWYHQDLQIRUPDWLND±,QIRUPDFLMVNHNRPSRQHQWH]DVSORãQRXSRUDER±GHO
.OLQLþQLSRGDWNL
Health informatics - General purpose information components - Part 3: Clinical
Medizinische Informatik - Allgemein verwendbare Informationskomponenten - Teil 3:
Klinische Informationen
Informatique de santé - Unité d'information dans les messages - Partie 3: Clinique
Ta slovenski standard je istoveten z: EN 14822-3:2005
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 14822-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2005
ICS 35.240.80
English Version
Health informatics - General purpose information components -
Part 3: Clinical
Informatique de santé - Unité d'information dans les Medizinische Informatik - Allgemein verwendbare
messages - Partie 3: Clinique Informationskomenten - Teil 3: Klinische Informationen
This European Standard was approved by CEN on 16 August 2005.
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. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists 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 Central Secretariat 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, Slovakia,
Slovenia, 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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14822-3:2005: E
worldwide for CEN national Members.
Contents Page
Foreword .4
Introduction.5
1 Scope .6
2 Normative references .6
3 Terms and definitions.6
4 Abbreviations .10
5 Rules governing the use of general purpose information components .10
6 General Purpose Information Components – an overview.12
7 General Purpose Information Components .20
7.1 Analysable Object GPICs .20
7.1.1 Analysable Object.20
7.1.2 Analysable Object In Use .24
7.1.3 Specimen.26
7.1.4 Related Analysable Object .31
7.1.5 Manufactured Specimen.32
7.1.6 Specimen Treatment.35
7.1.7 Related Specimen Treatment.38
7.1.8 Associated Specimen Treatment.39
7.1.9 Study Product .41
7.1.10 Object Characteristic .44
7.1.11 Preservation Material.46
7.1.12 Acquired Analysable Object.49
7.1.13 Analysable Object Acquisition.51
7.1.14 Related Object Acquisition.52
7.1.15 Acquisition Procedure.54
7.1.16 External Data Reference.59
7.2 Clinical Information GPICs.61
7.2.1 Clinical Information.61
7.2.2 Clinical Information Complex.63
7.2.3 Clinical Information Context .66
7.2.4 Related Clinical Information Complex.68
7.2.5 Clinical Information Item .70
7.2.6 Related Clinical Information.74
7.3 Clinical Observation GPICs.75
7.3.1 Clinical Observation .75
7.3.2 Related Patient Condition.78
7.4 Clinical Procedure GPICs.80
7.4.1 Clinical Procedure.80
7.4.2 Patient Preparation Procedure.84
7.4.3 Patient Preparation Substance .88
7.5 Counselling GPICs.89
7.5.1 Counselling .89
7.6 Unclassified Clinical Information GPICs .92
7.6.1 Unclassified Clinical Information.92
7.7 Laboratory And Diagnostic Investigation GPICs.95
7.7.1 Investigation Request.95
7.7.2 Related Investigation Request .101
7.7.3 Investigation Result Item.103
7.7.4 Related Investigation Result .107
7.7.5 Reference Limit .109
7.7.6 Reference Population .111
7.7.7 Investigation Specification.113
7.7.8 Body System .117
7.7.9 Related Body System .119
7.7.10 Measurement Procedure .121
7.8 Medication GPICs .124
7.8.1 Utilisation Guide .124
7.8.2 Medication Treatment.125
7.8.3 Medication Supply .128
7.8.4 Medicinal Product .132
7.8.5 Ingredient .135
7.8.6 Medicinal Product in Use .137
7.8.7 Medicinal Product Pack.139
7.8.8 Medicinal Product Pack in Use .143
7.8.9 Medication Appliance .145
7.8.10 Medication Appliance in Use.147
7.8.11 Medication Treatment Regimen .148
7.8.12 Dose Administration.150
7.8.13 Medication Treatment Condition .154
7.9 Treatment Routing GPICs .156
7.9.1 Routing Option.156
7.9.2 Routing Device.158
Care Encounter GPICs .161
7.9.3 Care Service Request .161
7.9.4 Related Service Request .165
7.9.5 Care Service Report.166
7.9.6 Related Service Report.170
7.9.7 Care Encounter .172
7.9.8 Related Care Encounter .176
7.10 Care Service Delivery GPICs.178
7.10.1 Care Service Delivery .178
7.10.2 Previous Related Activity .181
8 Acts, their context and inheritance .183
8.1 Introduction.183
8.2 Inheritance of Act Context .184
8.2.1 Method .184
8.2.2 Participation .184
8.2.3 Act Relationship.185
9 Structural vocabularies .187
9.1 Act class .187
9.2 Act mood .192
9.3 Act status .193
9.4 Act Relationship.193
9.5 Context Control Act Relationship.198
9.6 Context Control Participation .198
Annex A (informative) Rationale for this document on general purpose information components .199
Annex B (informative) How to read the models.200
B.1 Introduction.200
B.2 Classes .200
B.3 Associations between classes.200
B.4 Generalisation/Specialisation .201
Annex C (informative) Health Level 7 (HL7) reference information model.202
Annex D (informative) Common features of the general purpose information components.204
Annex E (informative) Localisation of the general purpose information components .206
Bibliography.207
Foreword
This European Standard (EN 14822-3:2005) 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 2006, and conflicting national standards shall be withdrawn at the
latest by April 2006.
This is part three of a multipart standard under the heading:
Health informatics - General purpose information components:
Part 1: Overview
Part 2: Non-clinical
Part 3: Clinical
This European Standard is definition of a set of clinical general purpose information components.
IMPORTANT — Within this draft document each of the General Purpose Information Components and
various sub-components are provided with identifiers, which are unique only internally within this
European Standard.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
Introduction
Many previous messaging and information structure standards for health have overlapping parts with a
number of objects being defined in separate documents, sometimes with small variations making
implementation of conformant applications more difficult. It therefore makes sense to define a set of general
purpose components that can be used for definition of message structures for different purposes . This
approach was suggested and approved as a strategy for CEN/TC 251 in the Short Strategic Study on
message standards alignment in 1999 examining a set of five European prestandards for messages. This
document is aiming to provide such a set of components and has been developed jointly with a new European
standard for Service Request and Report messages that is using the components defined herein.
Another important background to the development of this European Standard has been the wish for a
harmonisation of information models for health developed in Europe and the USA expressed in the
collaboration agreement entered March 2000 between CEN/TC 251 and HL7 (Health Level Seven, Ann Arbor.
Michigan). The goal was set for a maximum degree of alignment while maintaining their independence and
need to serve the business requirements of the respective markets but also to make the results available to
ISO for possible international standardization.
HL7 have adapted a general strategy similar to CEN/TC 251 using information modelling expressed in UML
(Unified Modeling Language) for their new standards and a lot of interaction and information sharing has
occurred between CEN experts and HL7 in an open spirit of collaboration.
This European Standard includes a large number of objects which are technically identical to descriptions in
draft documents of HL7, although partly described differently due to the fact that CEN is following the ISO
rules for drafting and presentation of standards which HL7 is not. CEN wishes to express its gratitude towards
HL7 experts for generously sharing their models with the European expert team.
This European Standard contains definition of a set of clinical general purpose information components.
Many aspects of this document require explanation which is provided in EN 14822-1.
See Annex A: Rationale for this document on General Purpose Information Components.
Modelling is British English spelling whereas Modeling is US English spelling.
1 Scope
This European Standard specifies the definition and structuring of information relating to entities that are
commonly encountered in communications with and between clinical information computer systems.
Within the scope of this European Standard is a description of components and their use. In particular, these
components relate to the following sub-domains:
Analysable objects: including samples, body parts, x-rays and other study products, together with their
collection and properties.
Clinical information: including observations, patient conditions, procedures, medication treatment,
investigations, counselling plus how these items are organised within a record.
Medicinal products: including appliances, dosage regimes,etc.
Routing aspects of medication treatment or other procedures.
Care Service information: including referrals for care services, care encounter information and scheduling.
2 Normative references
Not applicable.
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
analysable object
something derived from or to be derived from a patient as part of a diagnostic or laboratory investigation
[ENV 12539:1997 - revised]
NOTE 1 Analysed object is a generalisation that includes samples taken from a patient and physical or digital records
of information derived from a patient as part of a diagnostic service. An analysed object that is not a sample is referred to
as a study product.
NOTE 2 An analysed object need not exist in a tangible form but may represent something observed briefly by a
diagnostic service provider.
EXAMPLE 1 An x-ray image, a series of x-ray images, part of an x-ray image. The image may exist in a digitised form
or as a film.
EXAMPLE 2 An electrocardiograph (ECG) monitor tracing or a twelve lead ECG.
EXAMPLE 3 An organ removed during surgery or post-mortem, a biopsy, a particular slide containing a section taken
from a biopsy.
EXAMPLE 4 A view observed through an endoscope, an observation during an echocardiographic examination.
3.2
analysable object in use
information about an analysable object and the part it plays in an activity
EXAMPLE 1 Blood collected for a biochemical or hematological analysis during exploratory surgery.
EXAMPLE 2 Urine sample taken by the patient to a routine examination.
3.3
body system
demarcated system that is related to a subject of care or component of a subject of care
EXAMPLE 1 Systems: a man, an organ or anatomical structure.
EXAMPLE 2 Components: pathological cells in a biopsy from an organ.
3.4
care encounter
situation on the uninterrupted course of which one or more health care professionals delivers health care
services to a subject of care
[ENV 13940:2001 - modified]
3.5
care service
activity performed for a subject of care by a health care provider with the intention of directly or indirectly
improving or maintaining the health of that subject of care
[ENV 13940:2001 - modified]
3.6
clinical information
information about a patient, relevant to the health or treatment of that patient, that is recorded by or on behalf
of a healthcare professional
[ENV 13606:2000]
NOTE Clinical information about a patient may include information about the patient's environment or about related
people where this is relevant.
3.7
clinical information complex
healthcare record component representing an aggregation of other healthcare record components
[ENV 13606:2000]
3.8
clinical observation
clinical information excluding information about treatment and intervention
NOTE The observer may be the patient or related person (information about symptoms, family history, occupation or
life style), or a healthcare professional (information about physical signs, measurements, properties observed or
diagnoses). While information about the nature of a planned or performed treatment is excluded by the definition, clinical
observations may be recorded as the results of a treatment or during the course of a treatment or as its result.
3.9
clinical procedure
clinical intervention or treatment of a subject of care or group of subjects of care excluding counselling,
investigation or medication
3.10
General Purpose Information Component
GPIC
commonly useful information component that is a specialisation of classes in an international reference
information model which is intended to be used in the specification of an information service for health or of a
communication between health information systems
3.11
healthcare
provision of health related services
[ENV 13940:2001 - modified]
NOTE 1 This includes more than performing procedures on subjects of care. It also includes, for example, the
management of the information about patients, their health status and their relations within the health care framework.
NOTE2 In the present European pre-standard, the term 'care' may be used as a synonym for 'health care'.
3.12
healthcare agent
healthcare person, healthcare organisation, healthcare device or that performs a role in a healthcare activity
3.13
healthcare device
device or equipment involved in the direct or indirect provision of healthcare services to an individual or to a
population
[ENV 13606:2000]
EXAMPLES ECG machine, auto-analyser, syringe pump.
3.14
healthcare organisation
organisation involved in the direct provision of health care services
[ENV 13606-4:2000 - modified] [ENV 1613:1995, modified]
3.15
healthcare party
organisation or person involved in the direct or indirect provision of healthcare services to an individual or to a
population
[ENV 13606:2000]
3.16
healthcare professional
person involved in the direct or indirect provision of healthcare services to an individual or to a population
[ENV 13606:2000 –revised]
NOTE A carer or the patient may be a healthcare person.
3.17
medicinal appliance
device or piece of equipment which may be used by human beings or administered to animals for treating or
preventing disease, with the view to making medical diagnosis, to restore, correct or modify physiological
functions or to alleviate handicap
EXAMPLES Syringes, spacers for inhalation, diagnostic kits for pregnancy, bandages, catheters, diapers for
incontinence, orthopaedic shoes, colostomy bags, wheel chairs, pneumatic mattresses.
3.18
medicinal product
any substance or combination of substances, which may be administered to human beings or animals for
treating or preventing disease, with the view to making medical diagnosis or to restore, correct or modify
physiological functions
NOTE Some medicinal products are prescribed as a combination of a medicinal product and a medicinal appliance.
Such combinations are regarded in this document as medicinal products. [Directive 65/65/EEC, modified]
3.19
medicinal product package
delivery unit of a medicinal product in an outer container
[ENV 12610:1997]
3.20
medication supply
provision of one or more medicinal products for administration to a subject of care
3.21
medication treatment
administration of one or more medicinal products to a subject of care at one or more administration events
3.22
object characteristics
measurement made upon, or a measurement parameter of a specimen or study product
3.23
organisation
unique framework of authority within which a person or persons act, or are designated to act towards some
purpose
NOTE Groupings or subdivisions of an organisation may also be considered as organisations where there is need to
identify them for information interchange. [ISO 6523:1998]
3.24
preservation material
material or substance that is used in order to preserve a specimen or body part
3.25
specimen
one or more parts taken or to be taken from a system and intended to provide information on that system or
on a subsystem, or to provide a basis for decision on either of these
[ENV 12359:1997 - modified]
NOTE The system from which a sample is taken may be a patient or may itself be a specimen. The specimen is
assumed to be representative of the system. The term sample is sometimes used with the same meaning.
3.26
study product
identifiable record of information derived from a patient as part of a diagnostic service. It may take the form of
a physical object or may consist of digital information in an electronic information system
[ENV 12539:1997]
NOTE A study product differs from a sample in that a sample is something taken from a patient whereas a study
product is a recording of information derived from a patient. A consequence of this distinction is that a study product can
be copied. Furthermore, if the study product is represented in a digital form it can be held within or transferred between
computer systems.
EXAMPLE 1 An x-ray image, a series of x-ray images, part of an x-ray image.
EXAMPLE 2 The image(s) may exist in a digitised form or as a film.
EXAMPLE 3 An electrocardiograph (ECG) monitor tracing or a twelve lead ECG.
EXAMPLE 4 The tracing may exist on paper or as a digitised signal.
3.27
subject of care
person or other living subject, or group of persons or other living subjects, scheduled to receive or receiving
healthcare services
4 Abbreviations
NOTE All those marked by ‡ as defined in the CEN/TS 14796:2003 “Health Informatics - Data Types”.
BL ‡ Boolean
CD ‡ Concept Descriptor
CS ‡ Coded Simple value
CV ‡ Coded Value
ED ‡ Encapsulated Data
GP General Practitioner
GPIC General Purpose Information Component
II ‡ Instance Identifier
IVL ‡ Interval
IVL ‡ Interval of Physical Quantity
IVL ‡ Interval of Time
INT ‡ Integer
PQ ‡ Physical Quantity
ST ‡ String
TS ‡ Time stamp (point in time)
UML Unified Modelling Language
5 Rules governing the use of general purpose information components
5.1
When using a GPIC, a system or communication protocol which conforms to this document shall implement all
of the features (classes, associations, attributes) that are described within the GPIC core . In particular, a
conformant system that utilises a GPIC shall be able to receive and process information present in all classes
and attributes, even where these classes and attributes are specified as being optional.
A conformant system that utilises a GPIC to send information shall not be obliged to populate optional classes
or attributes.
5.2
Each of the classes and embedded GPICs that constitute a GPIC description has a class type. These are
shown as follows :
3 See Annex B: How to read the models
.
4 See Annex C: Health Level 7 (HL7) Reference Information Model
.
Describe actions, plans etc. Examples include observations, tests,
A
referrals, transportation etc.
Act
Relationships between acts. Often used to group Acts together, for
AR
example, a test result with a clinical observation.
Act
Relationship
Used to links an Act to Entities. May include information about the
P
type of participation of the Entity.
Participation
Used to provide information about the roles entities play.
R
Role
Used to link two Entity/Role pairs together, for example
RL
person/employee Å> organisation/employer.
Role link
Describe physical things. Examples include people, animals,
E
organisations, places, materials, devices etc.
Entity
For each GPIC there is a definition of the type(s) of objects to which the GPIC may be attached within any
external models or implementations. A conformant system will restrict GPIC use accordingly .
5.3
GPICs may be associated with other GPICs in ways which extend their functionality. These extensions are
informative in nature and will not subject to conformance testing.
5.4
A user community, e.g. a national body or a message development agency, may wish to ‘localise’ a GPIC for
use in a particular circumstance. The rules which underpin such localisation are :
All mandatory attributes and associations shall be present in any design using the GPIC, i.e. it is not
permitted to omit these features.
A user community may in any part of a communication or system design:
specify that certain specialisations of a general class are not allowed;
specify that certain optional attributes or associations are omitted;
restrict (constrain) a data type: For example, the data type ST (string) being defined in place of ED
(multimedia data);
define constraints on the allowable values of an attribute;
5 See Annex D: Common features of the General Purpose Information Components
.
See Annex E: Localisation of the general purpose information components.
define constraints on the vocabulary sets that may be associated with a coded attribute.
A user community shall not:
omit mandatory attributes and associations but may restrict values and vocabulary sets as outlined
above;
add attributes;
add associations except to other GPICs as formal extensions.
5.5
User communities may create new GPICs.
6 General Purpose Information Components – an overview
GPIC Name Description/Use
AnalysableObject Information about something derived from, or to be
derived from, a living subject of care, or a physical
R
location, as part of a diagnostic or laboratory
investigation.
This GPIC shall be used only where the application or
communication about this entity is concerned with a:
Specimen, i.e. substances or samples that are
analysed in laboratory investigations or;
Study products such as ECG tracings, x-rays, digital
representation of an x-ray etc.
NOTE Where it can be identified that only one of these
options is required, and where the Role interface and/or the
associations to the external GPICs are required, the user
should utilise this GPIC but specify a restriction to either the
Specimen GPIC or StudyProduct GPIC specialisation.
AnalysableObjectInUse An AnalysableObject GPIC with a Participation interface
allowing it to be associated with an action or activity.
P
EXAMPLES
1) Blood for a biochemical or hematological
analysis collected during exploratory surgery.
2) Urine sample taken by the patient to a routine
examination.
GPIC Name Description/Use
Specimen Information about one or more parts taken or to be taken
from a system and intended to provide information on
E
that system or on a subsystem, or to provide a basis for
decision on either of these.
This GPIC may be used in the following situations:
1) In its own right when it is used to specify
information concerning a non-manufactured
substance without the explicit use of the
AnalysableObject class
2) As a specialisation of the AnalysableObject
class within the AnalysableObject GPIC where
the user or application needs to:
leave open the possibility of referring to a
specimen or study product;
provide a role interface as in the
AnalysablObject GPIC (Note that it is
possible to restrict the AnalysableObject
GPIC so as to only include the possibility
of describing a specimen);
provide links to external GPICs such as
ObjectCharacteristic, BodySystem or
acquisition details.
NOTE If there is a requirement to relate this specimen to
other specimen use the RelatedAnalysableObject facility within
the AnalysableObject GPIC.
RelatedAnalysableObject Provides a means of linking a specimen or study product
to a related specimen or study product.
RL
ManufacturedSpecimen Information about a sample of material that is a
representative part of a manufactured substance.
R
EXAMPLES A sample of vaccine, blood products.
SpecimenTreatment Information about any physical or chemical treatment of
a specimen.
A
EXAMPLES Freezing, centrifuging, treatment with a
preservation material.
RelatedSpecimenTreatment SpecimenTreatment GPIC with a Participation interface.
This permits the treatment to be associated with a
P
specimen through RelatedAnalysableObject GPIC.
GPIC Name Description/Use
AssociatedSpecimenTreatment Information about the treatment of a specimen.
AR
Used where information about the treatment of a
specimen needs to be associated with another action,
i.e. obtaining the sample, and especially where a
sequential set of treatment procedures are carried out
upon a particular specimen.
1) This GPIC allows a record of a clinical
StudyProduct
investigation result item to refer to a physical or
E
digital record made during an investigation.
2) This GPIC may be used in the following
situations:
in its own right when it is used to specify
information concerning a non-
manufactured substance without the
explicit use of the AnalysableObject class;
as a specialisation of the AnalysableObject
class within the AnalysableObject GPIC
where the user or application needs to:
leave open the possibility of referring
to a specimen or study product;
provide a role interface as provided in
the AnalysablObject GPIC (Note that it
is possible to restrict the
AnalysableObject GPIC so as to only
include the possibility of describing
study product);
provide links to external GPICs such
as ObjectCharacteristic, BodySystem
or acquisition details.
NOTE If there is a requirement to relate this study product
to other study products the RelatedAnalysableObject facility
should be used within the AnalysableObejct GPIC.
ObjectCharacteristics Information about a measurement made upon, or a
measurement parameter of a specimen or study
P
product.
PreservationMaterial Information about a material or substance that is used in
order to preserve a specimen or body part.
R
AcquiredAnalysableObject Information about an analysable object which has been,
is to be, acquired.
P
Used to relate information about an analysable object to
some activity.
GPIC Name Description/Use
AnalysableObjectAcquisition Information about the acquisition of the analysable
object.
P
Used to relate information about the acquisition
procedures to the associated analysable object.
RelatedObjectAcquisition An AnalysableObjectAcquisition GPIC with a Role
interface.
R
Used to related the acquisition information directly to the
analysable object entity
AcquisitionProcedure Information about how an analysable object has or is to
be obtained.
A
ExternalDataReference Reference to external information stored in digital form.
R
ClinicalInformation Information about a patient, relevant to the health or
treatment of that patient, that is recorded by or on behalf
A
of a healthcare professional.
An abstract class which may be specialised as a
ClinicalInformationComplex or ClinicalInformationItem
GPIC.
EXAMPLES An observation, a laboratory result, results of
an examination, a set of related laboratory results, clinical
information relevant to a referral, current medication, family
history.
ClinicalInformationComplex Description of the ‘context’ or ‘container’ that is used to
organise one or more items of clinical information.
A
A collection of clinical information items equates to a
‘complex’ in ENV 13606 terminology.
ClinicalInformationComplex is a specialisation of
ClinicalInformation
ClinicalInformationComplex is further specialised as one
of:
ClinicalInformationContext (default)
CareServiceRequest
CareServiceReport
CareEncounter
ClinicalInformationContext Default specialisation ClinicalInformationComplex which
describes the ‘context’ or ‘container’ that is used to
A
organise one or more items of clinical information.
GPIC Name Description/Use
ClinicalInformationItem Single unit of clinical information that in a certain context
is considered indivisible.
A
NOTE The context may mean that this component’s
content may represent for example either a single clinical
statement or a single complex type such as an x-ray report. Its
granularity is determined by the context.
A clinical information item equates to a ‘data item’ in
ENV 13606 terminology.
ClinicalInformationItem is a specialisation of
ClinicalInformation.
RelatedClinicalInformation Information about an item or collection of clinical
information with some relationship to some healthcare
AR
related activity.
Used primarily to associate a relevant set of clinical
information about a patient with a request or a report.
RelatedClinicalInformationComplex Information about an item or collection of clinical
information with some relationship to some other
AR
healthcare related activity or collection of
activities/documents.
ClinicalObservation A specialisation of ClinicalInformationItem which
provides a general description of a clinical observation.
A
A clinical observation may be composed of a single
observation or a number of sub-observations which are
summarised at the top level.
RelatedPatientCondition Information about any condition that is related to one or
more items of clinical information.
AR
ClinicalProcedure A specialisation of ClinicalInformationItem which
provides a general description of a clinical procedure.
A
PatientPreparationProcedure Information about conditions applied or substances
administered, that prepare or challenge a patient before
AR
or during the collection of an analysable object or the
performing of some other procedure(s).
Patient preparation procedure refers to something done
to the patient that is intended to affect or may
incidentally have affected:
an analysable ob
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