EN 14720-1:2005
(Main)Health informatics - Service request and report messages - Part 1: Basic services including referral and discharge
Health informatics - Service request and report messages - Part 1: Basic services including referral and discharge
1.1 The scope of the messages specified by this document comprises healthcare service requests and reports related to laboratory and diagnostic investigations [3.28] as well as specialist services [3.35] carried out by healthcare service providers on subjects of care [3.51]. They cover electronic information exchange between computer systems used by healthcare parties requesting the services of, healthcare service providers.
1.2 This document is applicable to messages requesting healthcare services or reporting results of healthcare services independent of medical specialty. The messages can be used for:
- laboratory services, such as clinical biochemistry, clinical microbiology and haematology;
- diagnostic services, such as radiology, anatomical pathology and nuclear medicine;
- specialist services, such as referral and discharge messages.
1.3 This document does not specify the manner in which healthcare services are divided between specialties as this varies in accordance with national and local practices.
1.4 This document is applicable to requests for new investigation or specialist service and also modifications of previously issued requests.
1.5 It is applicable both to the subject of investigation as well as samples that are obtained from subjects of investigation at the point of care or at any other location and submitted to the healthcare services, and to requests for investigation for which the healthcare service is requested to obtain samples. The subject of investigation can be a person, an animal, a group of animals or a material.
1.6 The messages support standing orders for healthcare services.
1.7 This document is applicable to new reports and modifications of previously issued reports.
1.8 The messages it specifies support the communication of partial, supplementary, complete and cumulative reports. Reporting modes which may be implemented using this document include:
- sending a requested healthcare service report only when all results a
Medizinische Informatik - Serviceabfragen und Berichtsnachrichten - Teil 1: Grundsätzliche Dienstleistungen inklusive ärztliche Überweisung und Entlassung
Informatique de santé - Messages de demande et de compte-rendu de prestation de santé - Partie 1 : Prestations de base y compris adressage et fin de prise en charge
1.1 Le domaine d'application des messages spécifiés dans le présent document comprend des demandes et des comptes-rendus de prestation de santé liés à des investigations de laboratoire et à des diagnostics [3.28], ainsi qu'à des interventions spécialisées [3.35] effectuées par des prestataires de santé en faveur de sujets de santé [3.51]. Les messages couvrent l'échange électronique d'informations entre des systèmes informatiques utilisés par des acteurs de santé demandant les services de prestataires de santé.
1.2 Le présent document s'applique aux messages demandant des prestations de santé ou informant des résultats de prestations de santé via des comptes-rendus indépendamment de la spécialité médicale. Les messages peuvent être utilisés pour :
- les prestations de laboratoires, par exemple biochimie, microbiologie et hématologie ;
- les diagnostics, par exemple radiologie, pathologie anatomique et médecine nucléaire ;
- les prestations spécialisées par exemple messages d'adressage et de fin de prise en charge.
1.3 Le présent document n'indique pas comment les prestations de santé se répartissent en spécialités car ceci varie en fonction des pratiques locales et nationales.
1.4 Le présent document s'applique aux demandes de nouvelles investigations ou d'interventions spécialisées ainsi qu'aux modifications de demandes émises antérieurement.
1.5 Il s'applique à la fois au sujet d'investigation et aux échantillons issus du sujet d'investigation sur le lieu de santé ou en tout autre lieu et soumis au services de santé et aux demandes d'investigation pour lesquelles le service de santé doit obtenir des échantillons. Le sujet d'investigation peut être une personne, un animal, un groupe d'animaux ou un matériel.
1.6 Les messages se conforment aux règles permanentes propres aux prestations de santé.
1.7 Le présent document s'applique aux nouveaux comptes-rendus et aux modifications de comptes-rendus émis antérieurement.
Zdravstvena informatika – Sporočila z zahtevami in poročili za (diagnostično) storitev – 1. del: Osnovne storitve, ki vključujejo napotitev in odpustitev (pacientov)
General Information
- Status
- Withdrawn
- Publication Date
- 29-Mar-2005
- Withdrawal Date
- 13-Jun-2011
- Technical Committee
- CEN/TC 251 - Medical informatics
- Drafting Committee
- CEN/TC 251/WG 1 - Information models
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 14-Jun-2011
- Completion Date
- 14-Jun-2011
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 14720-1:2005 is a standard published by the European Committee for Standardization (CEN). Its full title is "Health informatics - Service request and report messages - Part 1: Basic services including referral and discharge". This standard covers: 1.1 The scope of the messages specified by this document comprises healthcare service requests and reports related to laboratory and diagnostic investigations [3.28] as well as specialist services [3.35] carried out by healthcare service providers on subjects of care [3.51]. They cover electronic information exchange between computer systems used by healthcare parties requesting the services of, healthcare service providers. 1.2 This document is applicable to messages requesting healthcare services or reporting results of healthcare services independent of medical specialty. The messages can be used for: - laboratory services, such as clinical biochemistry, clinical microbiology and haematology; - diagnostic services, such as radiology, anatomical pathology and nuclear medicine; - specialist services, such as referral and discharge messages. 1.3 This document does not specify the manner in which healthcare services are divided between specialties as this varies in accordance with national and local practices. 1.4 This document is applicable to requests for new investigation or specialist service and also modifications of previously issued requests. 1.5 It is applicable both to the subject of investigation as well as samples that are obtained from subjects of investigation at the point of care or at any other location and submitted to the healthcare services, and to requests for investigation for which the healthcare service is requested to obtain samples. The subject of investigation can be a person, an animal, a group of animals or a material. 1.6 The messages support standing orders for healthcare services. 1.7 This document is applicable to new reports and modifications of previously issued reports. 1.8 The messages it specifies support the communication of partial, supplementary, complete and cumulative reports. Reporting modes which may be implemented using this document include: - sending a requested healthcare service report only when all results a
1.1 The scope of the messages specified by this document comprises healthcare service requests and reports related to laboratory and diagnostic investigations [3.28] as well as specialist services [3.35] carried out by healthcare service providers on subjects of care [3.51]. They cover electronic information exchange between computer systems used by healthcare parties requesting the services of, healthcare service providers. 1.2 This document is applicable to messages requesting healthcare services or reporting results of healthcare services independent of medical specialty. The messages can be used for: - laboratory services, such as clinical biochemistry, clinical microbiology and haematology; - diagnostic services, such as radiology, anatomical pathology and nuclear medicine; - specialist services, such as referral and discharge messages. 1.3 This document does not specify the manner in which healthcare services are divided between specialties as this varies in accordance with national and local practices. 1.4 This document is applicable to requests for new investigation or specialist service and also modifications of previously issued requests. 1.5 It is applicable both to the subject of investigation as well as samples that are obtained from subjects of investigation at the point of care or at any other location and submitted to the healthcare services, and to requests for investigation for which the healthcare service is requested to obtain samples. The subject of investigation can be a person, an animal, a group of animals or a material. 1.6 The messages support standing orders for healthcare services. 1.7 This document is applicable to new reports and modifications of previously issued reports. 1.8 The messages it specifies support the communication of partial, supplementary, complete and cumulative reports. Reporting modes which may be implemented using this document include: - sending a requested healthcare service report only when all results a
EN 14720-1:2005 is classified under the following ICS (International Classification for Standards) categories: 11.020.10 - Health care services in general; 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 14720-1:2005 has the following relationships with other standards: It is inter standard links to ENV 12538:1997, ENV 1613:1995, ENV 12539:1997. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 14720-1:2005 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-september-2005
1DGRPHãþD
SIST ENV 12538:2003
SIST ENV 12539:2003
SIST ENV 1613:2003
LDJQRVWLþQR=GUDYVWYHQDLQIRUPDWLND±6SRURþLOD]]DKWHYDPLLQSRURþLOL]DG
VWRULWHY±GHO2VQRYQHVWRULWYHNLYNOMXþXMHMRQDSRWLWHYLQRGSXVWLWHY
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Health informatics - Service request and report messages - Part 1: Basic services
including referral and discharge
Medizinische Informatik - Serviceabfragen und Berichtsnachrichten - Teil 1:
Grundsätzliche Dienstleistungen inklusive ärztliche Überweisung und Entlassung
Informatique de santé - Messages de demande et de compte-rendu de prestation de
santé - Partie 1 : Prestations de base y compris adressage et fin de prise en charge
Ta slovenski standard je istoveten z: EN 14720-1:2005
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 14720
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2005
ICS 35.240.80 Supersedes ENV 12538:1997, ENV 12539:1997, ENV
1613:1995
English version
Health informatics - Service request and report messages - Part
1: Basic services including referral and discharge
Informatique de santé - Messages de demande et de Medizinische Informatik - Serviceabfragen und
compte-rendu de prestation de santé - Partie 1 : Berichtsnachrichten - Teil 1: Grundsätzliche
Prestations de base y compris adressage et fin de prise en Dienstleistungen inklusive ärztliche Überweisung und
charge Entlassung
This European Standard was approved by CEN on 14 February 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 14720:2005: E
worldwide for CEN national Members.
Contents
Page
Foreword.6
Introduction .7
1 Scope .8
2 Normative references .9
3 Terms and definitions .10
4 Symbols and abbreviations .17
5 Implementation requirements .18
5.1 General conformance requirements.18
5.2 Implementation recommendations .18
6 Communication requirements and scenarios .18
6.1 General.18
6.1.1 General.18
6.1.2 Communication roles .19
6.1.3 Trigger events .19
6.1.4 Message types .19
6.1.5 Receiver responsibilities .21
6.1.6 Message sequences .21
6.2 Message interactions .24
6.2.1 General.24
6.2.2 New healthcare service request.24
6.2.3 Healthcare service request modification .24
6.2.4 Healthcare investigation request modification.24
6.2.5 Additional healthcare investigation request.24
6.2.6 Copy of request.24
6.2.7 Healthcare service request response.25
6.2.8 New healthcare service report.25
6.2.9 Healthcare service report modification .25
6.2.10 Healthcare report investigation modification .25
6.2.11 Healthcare report additional investigation.25
6.2.12 Copy of report .25
7 Hierarchical message descriptions (HMD).26
7.1 Introduction to HMDs .26
7.2 Use of General Purpose Information Components (GPICs) in HMDs .26
7.3 Description of the HMDs/HCDs .27
7.3.1 General.27
7.3.2 Structure of message .27
7.3.3 Occurrences.27
7.3.4 Name of message element.28
7.3.5 GPIC .28
7.3.6 Use of message element.28
7.3.7 Deviation for each of the derived messages .28
7.4 Common hierarchical components.29
7.4.1 General.29
7.4.2 Healthcare agent.29
7.4.3 Care service recipient .32
7.4.4 Care location .33
7.4.5 Subject of investigation .34
7.4.6 Analysable object .36
7.4.7 Clinical information .37
7.5 Requirements common to all message types .41
7.5.1 Message content.41
7.5.2 Status of message content.43
7.6 Healthcare service request message .43
7.6.1 Scope and description of message .43
7.6.2 Message information model .44
7.6.3 HMD.45
7.7 Healthcare service report message .48
7.7.1 Scope and description of message .48
7.7.2 Complex investigation result items .48
7.7.3 Message information model .49
7.7.4 HMD.50
Annex A (normative) Domain Information Model.53
A.1 Introduction.53
A.1.1 General.53
A.1.2 The Modelling Approach.53
A.1.3 Diagrammatic presentation .53
A.1.4 Description of model components .54
A.1.5 Description of the models.55
A.2 Model overview.55
A.2.1 Model.55
A.2.2 High-level description .56
A.3 Message package .58
A.3.1 Model.58
A.3.2 Model components.58
A.3.3 Description of Message package.59
A.4 Healthcare service request package .60
A.4.1 Model.60
A.4.2 Model components.60
A.4.3 Description of healthcare service request package .60
A.5 Service Report Package.62
A.5.1 Model.62
A.5.2 Model components.62
A.5.3 Description of Healthcare service report package.62
A.6 Subject Of Investigation Package.63
A.6.1 Model.63
A.6.2 Model components.64
A.6.3 Description of subject of investigation package.66
A.6.4 Model of care service recipient .68
A.6.5 Model components.68
A.6.6 Description of care service recipient.68
A.6.7 Model of subject relationships.69
A.6.8 Model components.70
A.6.9 Description of subject relations.70
A.7 Analysable object package.70
A.7.1 Analysable object model.70
A.7.2 Model components.71
A.7.3 Description of analysable object package.73
A.7.4 Analysable object acquisition model .74
A.7.5 Model components.74
A.7.6 Description of package .74
A.8 Clinical information package.75
A.8.1 Model.75
A.8.2 Model components.75
A.8.3 Description of package .76
A.8.4 Model of investigation request.77
A.8.5 Model components.77
A.8.6 Description of investigation request .77
A.8.7 Model of result item.78
A.8.8 Model components .78
A.8.9 Description of result item .78
A.8.10 Model of medication and clinical procedure.80
A.8.11 Model components .80
A.8.12 Description of medication and clinical procedure .80
A.9 Healthcare Agent Package.81
A.9.1 Model of healthcare agent .81
A.9.2 Model components .82
A.9.3 Description of healthcare agent package .83
A.9.4 Model of healthcare party .84
A.9.5 Model components .84
A.9.6 Description of healthcare party.84
Annex B (informative) Scenarios .86
B.1 General.86
B.2 Summary of the scenarios.86
B.3 Request Scenarios (including Specialist Service Request).86
B.3.1 General.86
B.3.2 Service to be performed on specimens supplied by the requester .87
B.3.3 Services that require scheduling prior to the receipt of the sample collected by the requester.87
B.3.4 Services performed on samples collected by the service provider.88
B.3.5 Services in which the subject of care is examined by the service provider .88
B.3.6 Services involving evaluation of an existing sample or study product.90
B.3.7 Modification of an existing request following any of the above scenarios.90
B.3.8 Cancellation of an existing request following any of the above scenarios.91
B.4 Report Scenarios (including Specialist Service Report) .92
B.4.1 General.92
B.4.2 Provisional reports .93
B.4.3 Corrections or updates of reports .93
B.4.4 Cancellations of reports.94
B.5 Illustrations of the different data types in a report.95
B.5.1 Reports including a discrete set of numeric values .95
B.5.2 Reports including a series or array of numeric values .95
B.5.3 Reports including graphical, image or signal information.95
B.5.4 Reports including results in the form of code values and/or text.96
B.5.5 Reports including proposed actions (plan items).97
B.6 Illustrations of various types of subject of investigation.97
B.6.1 Patient .97
B.6.2 Animal .97
B.6.3 Material .97
B.6.4 Subject of care and a related subject of care .97
B.7 Illustrations of various types of involved parties.98
B.7.1 Parties Involved .98
B.7.2 Healthcare service requests to Copy destinations .98
B.7.3 Healthcare service reports to Copy destinations.98
B.7.4 Healthcare service reports not to be sent to requester.99
B.8 Acceptance, progress reporting and follow-up scenarios.99
B.8.1 General.99
B.8.2 Response to a request for a healthcare service.99
B.8.3 Notification by the recipient of a report that he/she has seen the report.101
B.8.4 Management of call, recall and follow up of healthcare services.101
B.9 Scenarios specific to post-mortem studies .101
B.9.1 Clinical post-mortems .101
B.9.2 Forensic post-mortems.102
B.10 Services that involve two or more service providers .102
Annex C (informative) How to read the models.103
C.1 Introduction.103
C.2 Classes .103
C.3 Associations between classes .103
C.4 Types of Associations.104
C.4.1 Part-of relationships.104
C.4.2 References .104
C.5 Generalisation/specialisation.104
C.6 Summary of UML Notation.105
Index .106
Bibliography.108
Foreword
This document (EN 14720-1:2005) has been prepared by Technical Committee CEN/TC 251 “Health informatics”,
the secretariat of which is held by SIS.
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 September 2005, and conflicting national standards shall be withdrawn at the
latest by September 2005.
This document has been prepared under mandate M/255 given by the European Commission and the European
Free Trade Association.
This document supersedes ENV 1613:1995, ENV 12538:1997 and ENV 12539:1997.
This document includes a Bibliography.
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
The use of data processing and telecommunications capabilities have made possible the interchange of information
in machine-readable and machine processable formats. The Information Technology and Data Management
environment consists of a variety of computer systems with numerous hardware and operating system platforms.
Application programs span a wide range of qualities of design and support. Interoperability – the ability of software
and hardware on multiple machines from multiple vendors, to communicate – is the key to automated interchange
of information in healthcare. As interoperability [3.39] increases, it is essential to provide appropriate information
interchange standards [3.49].
Computer systems are in use for the storage and processing of information in many healthcare service
departments and clinical laboratories. This document provides a set of message types [3.42] that enable the
electronic transfer of messages in the healthcare services domain.
This document supersedes ENV 12539 (Medical informatics - Request and report messages for medical service
departments), ENV 12538 (Medical informatics - Referral and discharge messages) and ENV 1613 (Medical
informatics - Messages for exchange of laboratory information).
A combination of the following factors provide the motivation for this document:
— Standards are required to facilitate electronic transfer of healthcare services [3.27] related messages and
reports between the many systems currently used.
— Implementation of the messages specified by this document will enable the transmission of general messages
for electronic interchange between computer systems used by healthcare parties [3.25] in the healthcare service
domain.
— Electronic transfer of these healthcare service related messages and reports reduces the need for manual entry
and the risk of transcription errors. It also results in greater efficiency leading to more efficient and economic
healthcare provision.
— This document imposes EDI messages in the domain of healthcare services to be defined in a way that ensures
all necessary data is made available, thus significantly reducing the risk of misinterpretation of request and
report related messages. This document includes the hierarchical and linear message descriptions, together
with coding tables, where appropriate.
This document has been developed following the methods recommended in the CEN Report on "Medical
Informatics - Methodology for the development of healthcare messages" (CR 12587:1996). However, in
accordance with the decisions of CEN/TC 251, a different modelling technique has been used in compiling this
revised standard. A subset of the Unified Modelling Language (UML) has been used, as described in Annex C.
This document takes account of message information model development being undertaken by HL 7 version 3 and
aligns with HL7 v3 RIM version 1.20. HL7 is designated as an ANSI Accredited Standards Development
Organisation.
This document specifies messages in a syntax [3.53] independent form. Its requirements for conformance define
the structure for these messages. Compliant messages can be developed in a variety of implementation syntaxes
and these syntax specific implementations may be the subject of future standards.
This document is directly relevant to suppliers of computer systems for use in systems development. Its provisions
are also relevant to those planning, specifying, procuring or implementing information systems for use in clinical
laboratories, hospitals, general practices, clinical departments and specialist clinics.
1 Scope
1.1 The scope of the messages specified by this document comprises healthcare service requests and reports
related to laboratory and diagnostic investigations [3.28] as well as specialist services [3.35] carried out by
healthcare service providers on subjects of care [3.51]. They cover electronic information exchange between
computer systems used by healthcare parties requesting the services of, healthcare service providers.
1.2 This document is applicable to messages requesting healthcare services or reporting results of healthcare
services independent of medical specialty. The messages can be used for:
— laboratory services, such as clinical biochemistry, clinical microbiology and haematology;
— diagnostic services, such as radiology, anatomical pathology and nuclear medicine;
— specialist services, such as referral and discharge messages.
1.3 This document does not specify the manner in which healthcare services are divided between specialties as
this varies in accordance with national and local practices.
1.4 This document is applicable to requests for new investigation or specialist service and also modifications of
previously issued requests.
1.5 It is applicable both to the subject of investigation as well as samples that are obtained from subjects of
investigation at the point of care or at any other location and submitted to the healthcare services, and to
requests for investigation for which the healthcare service is requested to obtain samples. The subject of
investigation can be a person, an animal, a group of animals or a material.
1.6 The messages support standing orders for healthcare services.
1.7 This document is applicable to new reports and modifications of previously issued reports.
1.8 The messages it specifies support the communication of partial, supplementary, complete and cumulative
reports. Reporting modes which may be implemented using this document include:
— sending a requested healthcare service report only when all results are available;
— sending individual results as they become available;
— sending new results as part of a cumulative report;
— sending partial results.
1.9 The results may include numeric values, ranges, ratios, coded information, free text as well as large binary
objects (multimedia objects).
1.10 This document is not applicable to prescribing, dispensing and administration of medication or ordering blood
transfusion products. The EN is however, applicable for requesting and reporting of investigations in
connection with blood transfusions.
1.11 This document has not been developed to meet the needs of messages supporting administration, financing,
management, interpersonal mail or external quality control, nor of messages communicating sample
collection lists, work lists or queries.
1.12 This document does not support negative acknowledgement or error indication at the application level, nor
positive acknowledgment or cancellation messages at the application level.
1.13 The provisions of this document have been validated in the domains and for the purposes described above
(see 1.1 and 1.2). However messages conforming to this EN may be considered by some user communities
to be suitable for their needs for purposes outside this Scope. Use of the messages in such circumstances is
not precluded by the Scope.
1.14 Two groups of messages have been identified within Scope:
Group 1: Basic healthcare service request messages including referral messages;
Group 2: Basic healthcare service report messages including discharge messages.
1.15 These groups of messages support communication between healthcare parties [3.25]. The healthcare party
may be a person (such as a doctor or other healthcare professional [3.26]) or a healthcare organisation
[3.24] (such as a hospital, clinic or department).
1.16 A basic healthcare service request message is sent from a healthcare party in the role as healthcare service
requester to another healthcare party in the role of healthcare service provider as well as to other involved
parties (copy destinations).
1.17 A basic healthcare service report message is sent from a healthcare party in the role as healthcare service
provider to another healthcare party in the role as healthcare service requester and/or other involved
healthcare parties (copy destinations).
1.18 Messages for transmission of requests for healthcare services from a healthcare service provider, covered
by the scope of this document, should enable electronic interchange of the semantic content defined in the
hierarchical message descriptions (HMD) [3.36] for healthcare service request messages in Clause 6.
1.19 Messages for transmission of Reports from a healthcare service provider, covered by the scope of this
document, should enable electronic interchange of the semantic content defined in the HMDs for healthcare
service reports messages in Clause 6.
1.20 Implementable message specifications (IMS) [3.37] should conform to the HMDs defined in this document.
Defined messages or message subsets should support as a minimum all mandatory objects and attributes
defined in the HMD of this document. They should also support the relationships between all referenced
objects as defined by the HMD.
1.21 IMS should be expressed in terms of a syntax that is an International Standard except where the healthcare
user requirements cannot be met by using such a standard syntax.
1.22 When implementing information exchange based upon this document, data protection and confidentiality
[3.13] principles have to be guaranteed according to the laws and codes of professional practice actually in
force in the actual CEN member country. The mechanisms needed to secure data integrity [3.14], data
protection and confidentiality, authentication [3.4] of communicating parties and subjects of investigation are
outside the scope of this document. Guidance can be found in ISO/TR 18307.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references,
only the edition cited applies. For undated references, the latest edition of the referenced document (including any
amendments) applies.
CEN/TS 14796:2004, Health informatics – Data types
prEN 14822-1, Health informatics – General purpose information components – Part 1: Overview
prEN 14822-2, Health informatics – General purpose information components – Part 2: Non-clinical
prEN 14822-3, Health informatics – General purpose information components – Part 3: Clinical
prCEN/TS 14822-4, Health informatics – General purpose information components – Part 4: Message headers
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
analysable object
object derived from or to be derived from a subject of investigation as part of a healthcare service investigation
NOTE Analysed object is a generalisation that includes samples taken from a subject of investigation and physical or
digital records of information derived from a subject of investigation as part of a healthcare service. An analysed object that is
not a sample is referred to as a study product.
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
application
identifiable computer running a software process
3.3
attribute
a characteristic of an object or entity
[ENV 13730-1:2001]
3.4
authentication
the process of reliably identifying security subjects by securely associating an identifier and its authenticator
[ISO 7498-2:1989]
3.5
authorisation
the granting of rights, which includes granting of access based on access rights
[ISO 10181-2:1996]
3.6
care service recipient
person, animal or animal group that is the primary focus of one or more care services
NOTE This may be different from the subject of investigation.
3.7
clinical information
information about a subject of care, relevant to the health or treatment of that subject of care, that is recorded by or
on behalf of a healthcare professional
[ENV 1613:1995]
NOTE 1 Clinical data/information is related to the health and healthcare of an individual collected from or about an individual
receiving healthcare services. Includes a caregiver’s objective measurement or subjective evaluation of a patient’s physical or
mental state of health; descriptions of an individual’s health history and family health history; diagnostic studies; decision
rationale; descriptions of procedures performed; findings; therapeutic interventions; medication prescribed; description of
responses to treatment; prognostic statements; and descriptions of socio-economic and environmental factors related to the
patient’s health. [ASTM E1769, CPRI]
NOTE 2 Clinical information about a subject of care may include information about the subject of care’s environment or about
related people where this is relevant.
3.8
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