CR 14300:2002

SLOVENSKI STANDARD
SIST-TP CR 14300:2003
01-oktober-2003
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Health Informatics - Interoperability of healthcare multimedia report systems
Ta slovenski standard je istoveten z: CR 14300:2002
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TP CR 14300:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CR 14300:2003

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SIST-TP CR 14300:2003
CEN REPORT
CR 14300
RAPPORT CEN
CEN BERICHT
January 2002
ICS
English version
Health Informatics - Interoperability of healthcare multimedia
report systems
This CEN Report was approved by CEN on 14 December 2001. It has been drawn up by the Technical Committee CEN/TC 251.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, 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
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. CR 14300:2002 E
worldwide for CEN national Members.

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Contents
Foreword 7
1 INTRODUCTION 8
1.1 Executive Summary 8
1.2 Digital healthcare multimedia reports 9
1.3 Motivation 10
1.4 Aims and Objectives 10
1.4.1 Aims 10
1.4.2 Objectives 11
1.5 Method of Work 11
1.5.1 Traditional Healthcare Service Report Scenarios 11
1.5.2 Scenarios of healthcare multimedia reports 11
1.5.3 Multimedia report use cases 11
1.5.4 Conceptual Modelling 11
1.5.5 Logical data structures 12
1.5.6 Assessment of the applicability of relevant existing and emerging Standards and Specifications 12
1.5.7 Recommendations for use and/or extension of standards and Publicly Available Specifications 12
2SCOPE 13
3 REFERENCES AND BIBLIOGRAPHY 14
3.1 References 14
3.2 Bibliography 15
4 ABBREVIATIONS AND DEFINITIONS 16
4.1 Abbreviations 16
4.2 Definitions 17
5 REPORT SCENARIOS 22
5.1 Introduction 22
5.2 Healthcare Service Requests and Reports 22
5.3 Performing the Healthcare Procedure - production of results 23
5.3.1 Introduction 23
5.3.2 The Healthcare Procedure details 23
5.3.3 Healthcare Service Request approval 23
5.3.4 Appointment Scheduling 23
5.3.5 Acquisition Scheduling and Preparation 23
5.3.6 Acquisition and Processing of Healthcare Data 24
5.3.7 Data Processing 24
5.3.8 Preparation of material for reporting 24
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5.4 The nature and content of Reports. 25
5.4.1 Free Reporting 25
5.4.2 Structured Reporting 25
5.4.3 Assistance for the Reporting Clinician 26
5.4.4 Selection of supplied Healthcare Procedure Products 26
5.4.5 Healthcare Service Report sections 26
5.4.6 Recording the Report Words 27
5.4.7 Supplementary Healthcare Service Report 27
5.4.8 Other supplied Healthcare Procedure Products 28
5.4.9 Report Approval 28
5.4.10 Joint reporting of a Healthcare Procedure 28
5.4.11 One to one Conference 28
5.4.12 Peer to peer Consultation 28
5.4.13 Report Distribution 28
5.4.14 Case Conference of the Patient 29
5.5 Utilisation of the Healthcare Service Report and Healthcare Procedure Products 29
5.5.1 Utilisation by the Requester for diagnosis or follow up 29
5.5.2 General Practitioner 29
5.5.3 Hospital Clinician Consultation 29
5.5.4 Ward, Dentistry and Casualty staff 29
5.6 Utilisation of medical data for therapy 30
5.6.1 Surgeon in Theatre 30
5.6.2 Planning 30
5.6.3 Interventional imaging 30
5.6.4 Per operative imaging 30
5.6.5 Endoscopy 30
5.7 Audit 30
5.8 Epidemiology 30
5.9 Administration 30
5.10 Teaching and Research 31
5.11 Presentation of Healthcare Service Reports to recipients 31
6 MULTIMEDIA SCENARIOS 32
6.1 Healthcare Multimedia Reports 32
6.1.1 Presentation Requirements - Computer Interaction 32
6.1.2 General Requirements 33
6.1.3 HCMR links to Healthcare Procedure Products 34
6.2 Examples of multimedia reports 34
6.2.1 Report on endoscopy. 34
6.2.2 Report on coronary angiography. 34
6.2.3 Report on a CT scan of a pituitary tumour. 34
6.2.4 Report on a gated Tc-99m Tetrofosmin cardiac single photon emission Tomography, SPET,
procedure. 35
6.2.5 Further Healthcare Procedure scenarios 35
6.2.6 Summary and Conclusions 36
6.2.7 Additional Requirements 37
6.3 Healthcare multimedia report data 37
6.3.1 Multimedia report contents 38
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6.3.2 Healthcare Procedure Product logical data structures 38
6.4 Interoperability of multimedia report systems 40
7 USE CASE MODELLING 42
7.1 Introduction 42
7.2 Use Case Models of processes 42
7.2.1 Introduction 42
7.2.2 Sequence diagrams 44
8 CONCEPTUAL MODELS 57
8.1 Rationale 57
8.2 Level 0: Healthcare Service Request / Healthcare Service Report generic model 57
8.3 Level 1: Healthcare Multimedia Report (HCMR) 59
8.3.1 Healthcare Multimedia Report - Structuring, Content and HCMR links 59
8.3.2 Healthcare Multimedia Report - Multimedia Performance 62
8.4 Level 2: Diagnostic Imaging and Vital Signs Studies Reports 64
8.4.1 “Rendered procedure product” Entities 65
8.4.2 Life Cycle Entities Model 66
8.5 Level 3: Application of the model to Diagnostic Imaging 67
9 APPLICABILITY OF EXISTING STANDARDS AND SPECIFICATIONS 69
9.1 Introduction 69
9.2 Nature of HCMR 69
9.3 Nature of Standards to support HCMR 69
9.4 Generic report standards and specifications for Report Words 70
9.4.1 Relation to ENV 13606 - Part 1 and Part 2 70
9.4.2 Supplement 23 Structured Reporting 71
9.4.3 ENV12539-diagnostic services messages 74
9.4.4 HL7 74
9.5 Composite rendered procedure products 75
9.5.1 Imaging Modifiable rendering format 75
9.5.2 Waveform and other non-imaging data 76
78
9.6 Creation and modification of HCMR
78
9.7 Presentation of HCMR to report recipient in Navigation mode
78
9.7.1 Navigation mode Presentation in modifiable form
79
9.7.2 Navigation mode Presentation in non-modifiable form
79
9.8 Presentation of HCMR to report recipient in Performance mode
79
9.8.1 Performance mode Presentation in modifiable form
9.8.2 P 79
erformance mode Presentation in non-modifiable form
9.9 Mapping tables 80
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10 CONCLUSIONS 88
10.1 Nature of HCMR 88
10.2 Generic report standards and specifications 88
10.3 Composite rendered Healthcare Procedure Products 88
10.3.1 Modifiable rendering format 88
10.3.2 Non- modifiable rendering format 88
10.4 Creation and modification of H522CMR 89
10.5 Presentation to report recipient 89
10.5.1 Presentation in modifiable form 89
10.5.2 Presentation in non-modifiable form 89
11 RECOMMENDATIONS 89
11.1 Recommendation 1 89
11.2 Recommendation 2 89
11.3 Recommendation 3 90
11.4 Recommendation 4 90
11.5 Recommendation 5 90
11.6 Recommendation 6 90
11.7 Recommendation 7 90
ANNEX TO THE CEN REPORT 91
1. MULTIMEDIA REPORTS OVERVIEW 94
1.1 Healthcare Service Reports 94
1.1.1 The Traditional Healthcare Service Report 94
1.1.2 The traditional Healthcare Service Report in electronic form 94
1.1.3 The Healthcare Multimedia Report 95
1.1.4 The record of a Healthcare Multimedia presentation 95
1.2 Interoperability 96
1.3 Interoperability of networked co-operating applications 98
1.4 Images and Medical images 98
1.4.1 Digital Image Data and Digital Images 99
1.4.2 Greyscale images - thresholding. 99
1.4.3 True and Pseudo Colour Images 99
1.4.4 Image descriptive data 99
1.5 Non-image Medical Device data 100
2. PATIENT DATA ACQUISITION 100
2.1 Introduction 100
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2.2 Patient Data Acquisition, processing and reporting 100
2.2.1 Introduction -Healthcare Service Requests and Healthcare Service Reports. 100
2.2.2 Requesting a diagnostic service 101
3. PATIENT AND HEALTHCARE SERVICE REPORT DATA 102
3.1 Patient Measurement and Information item Data structures 102
3.1.1 Example of Patient data acquisition processing and display 102
3.1.2 Information Item Procedure Product Data Structure 104
3.1.3 Presentation of Information items - Labels and Annotation 104
3.1.4 Information item data structures 105
3.1.5 Vector and image descriptive data 106
3.2 Healthcare Service Report data records 107
3.2.1 Report Text 107
3.2.2 Rendered Healthcare Procedure Products 108
3.2.3 Multimedia Performance 108
3.3 Vital signs acquisition and reporting 108
3.3.1 EEG measurement scenario 108
3.3.2 Epilepsy intensive monitoring scenario 109
3.3.3 ENMG measurement scenario 110
3.3.4 Intensive care monitoring scenario 111
4. MULTIMEDIA REPORT DEMONSTRATION 112
4.1 Navigation presentation recorded as HTML file 112
4.2 Performance Presentation recorded as SMIL file 114
5. UNIFIED MODELLING LANGUAGE NOTES 115
5.1 Introduction 115
5.2 Use Cases 115
5.3 Sequence Diagrams 117
5.4 Class Diagrams 117
5.5 Relationships 118
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Foreword
This CEN REPORT has been prepared by Technical Committee CEN/TC 251 "Health informatics", the
secretariat of which is held by SIS under mandate BC/CEN/03/255/97/23.6 by the European Commission and the
European Free Trade Association. This work item was originally entitled Medical Multimedia and Related
Interoperability Data Format but CEN/TC 251 decided to change the title to Interoperability of healthcare
multimedia report systems in order to reflect more accurately the main focus.
This report has been produced by members of the Project Team 34 MULTIMED under the supervision of
CEN/TC 251/WGIV: Technology for Interoperability.
This CEN Report is not a standard and does not contain the definition of a new data file format.
Defined terms are shown with the first letter of each word in capitals.
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1 INTRODUCTION
1.1 Executive Summary
This CEN Report is concerned with the interoperability of systems for the creation, modification and presentation
of digital healthcare multimedia report records. In addressing these issues the purpose of this CEN Report is:

to examine the nature of healthcare reports as delivered and viewed using traditional methods

to recommend methods for the presentation of electronic healthcare service reports using multimedia
facilities

to assess the suitability of existing and emerging standards and specifications

to make recommendations for future work to enable the implementation of multimedia reports within the
clinical process.
Reports presented using electronic multimedia facilities should, by comparison with commonly used existing
methods, enable improved communication of the information obtained by service departments to those who
request their services, thus leading to improved quality of Healthcare.
This report is intended to inform standards makers, systems designers and healthcare professionals about the
nature of healthcare multimedia report records and show the way for the development of clinically viable
implementations.
The domain of Healthcare Procedure Reporting is reviewed by means of scenarios which take account of
previous CEN/TC 251 work and the views of clinicians and medical informaticians obtained by consultation. The
two most common means by which Healthcare Service Reports are traditionally presented to clinicians are
identified as a) report text on paper accompanied by optional supporting results in hardcopy form (e.g., X-Ray
films) and b) live presentation, for example, as part of a case conference.
Multimedia Scenarios explain the application of multimedia facilities in the domain of Healthcare Service Reports
and their subsequent use. Use cases illustrate the creation, amendment and subsequent use of healthcare
multimedia reports. Conceptual models are derived from the use cases and illustrate the generic logical data
structures required to record healthcare multimedia reports and the data presented. This CEN Report concludes
that the clinical needs for healthcare multimedia reports may be served by presentation in two modes:
a) Navigation mode: The report text is presented in a form such as that supported by a Web Browser. A clinician
can select as much or as little of the available material for presentation as is needed in the current clinical
situation in the same way as is currently done when a written report on paper is accompanied by selected
Healthcare Procedure Products such as images in hardcopy form. He/she also decides the order in which to
view the available material.
b) Performance mode: The report is presented in a form similar to a lecture type presentation, for example, as
part of a case conference and would appear to the recipient in the form of a video performance. The items and
their order of presentation cannot be altered from that chosen by that report author (apart from changes
implemented by the use of video like controls such as pause rewind, etc.), i.e. the material must be viewed in the
way the author believes to be most appropriate.
In short, a Navigation Mode record specifies the layout and rendering for a set of procedure products in space. A
Performance Mode record specifies how different Procedure Products are to be presented during a specified
period of time.
This CEN Report uses the analogy of the performance of a piece of orchestral music as represented in the
conductor's music score. In the case of a healthcare multimedia report Performance mode score there will be
one line for each presentation channel, such as a defined region of a display window or sound channel. The
score specifies the sequence and duration for the presentation of sets of healthcare information items, such as
images and annotations, in a number of display regions, perhaps with synchronised sound such as a 'voice over'
and annotation by fixed regions of interest and/or a pointer.
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This CEN report explains the nature of the data to be presented as well as the presentation record data (score)
for performance mode and Navigable record data for Navigation mode. It is noted that the report text may be
required as the legally binding result of a healthcare service procedure. The availability of relevant existing
standards to support the identified needs is reviewed and recommendations for enhancement of existing
standards and creation of new standards are made.
This CEN Report concludes that Web-based and other standards/specifications, which support most of the
identified requirements for the exchange of healthcare multimedia report (HCMR) records already exist. These
standards/specifications also provide support of the identified presentation modes when interaction by the
recipient is not required (e.g., no windowing of images, etc.). One of the deliverables of this CEN Project is a
demonstration package that includes digital records of both Navigation mode and Performance mode HCMR
presentation.
Standards do not, however, exist for the creation and amendment of the record of Multimedia Presentations in
interactive form (record of the layout and rendering parameters of the presented procedure products). It is
recommended that authoring tools be developed to enable the production of healthcare multimedia report
records using the identified Navigation and Performance modes of presentation. These need to support both
interactive and non-interactive forms to enable co-operation between medically qualified and non-medically
qualified Healthcare Professionals in the task of producing multimedia reports. This should be implemented in
collaboration with relevant groups, including CEN/TC 251, ISO/TC 215, HL7 and DICOM.
1.2 Digital healthcare multimedia reports
A digital multimedia document may be defined as a document that includes numerical representations of
information that has been presented using different media. Such a document constitutes a digital record of a
multimedia presentation. The monomedia items presented may include for example: text (structured or free), a
static image (picture), a time series of images, a graphics entity (such as might delineate a Region of Interest), a
voice sound clip. One such monomedia entity may be related to another. For example, a Region of Interest may
need to be aligned in space upon the image to which it applies. A sound clip may need to be aligned in time with
a time series of images (synchronised). Multimedia presentation systems are, of course, also capable handling a
monomedia document (a document requiring presentation using one medium only e.g., text) and multimedia
documents which do not invoke synchronisation.
Interoperability of systems for the creation, modification and presentation of digital healthcare multimedia report
records depends on understanding and consistency in the representation of data. The key requirements for
healthcare multimedia report presentation are:
a) that appropriate use is made of multimedia facilities to enhance the communication of information from
reporting clinician to recipient and;
b) that the recipient sees and hears effectively the same things when he/she observes a presentation of the
multimedia report as the clinician saw and heard when the report was recorded.
The understanding of the requirements for interoperability of healthcare multimedia report systems requires an
understanding of the nature of the Healthcare Procedure Product data which is presented and the methods of
presentation. This CEN report includes discussion of the nature of the logical data structures required to carry
Healthcare Procedure Product data and healthcare multimedia report record data.
One of the main reasons for the need for specific Healthcare Standards is that medical images are of a different
nature from images generally used by multimedia applications. A medical image, such as the image rendered
from a regular array of X-Ray attenuation values acquired by a Computed Tomography (CT) modality, is a Digital
Image. A Digital Image is a visual representation of a Digital Image Data matrix. In order for an application to
present such an image on a screen two sets of data are required a) the Digital Image Data matrix and b) the
rendering data. In the case of a CT image presentation to the reporting clinician on the display screen of a
multimedia reporting system, facilities will be provided for him/her to adjust the rendering parameters. These are
generally controlled by means of controls, called window controls, which select the range of X-Ray attenuation
values to be displayed. By adjustment of these controls, the reporting clinician can select the most appropriate
settings to demonstrate the image features referred to in the Report Words.
A number of stages in the life history of a Healthcare service report may be identified. First a report instance is
created and associated with the request. Usually some or all of the report content is immediately recorded
following the report instance creation. The report content is then built up by assembling and adjusting the
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presentation of a number of components (Report Words, images, Curves, etc.). This process may be
accomplished during one or more editing sessions during which there are no restrictions on the modifications
which may be made to the report content (addition or removal of sections of Report Words, addition or removal
of presented Healthcare Procedure Products, adjustment of presentation parameters). There may be a number
of approval stages for the various components. Finally the whole report is approved (signed off) and is ready for
dispatch. Usually the data will be sent out in a form that does not allow the recipient to alter the presentation
parameters such as image windowing.
Subsequently it may be found that errors exist in the approved (signed off report). There are two commonly used
methods for dealing with this situation:
a) No changes are made to the original approved report content but a section is added
b) The faulty report is withdrawn and is superseded by a new report instance without those errors which in turn
is approved (Signed off).
From the above it is clear that applications for the creation, modification and presentation of multimedia report
records must support constrained and unconstrained modification of the healthcare multimedia report record. In
particular, applications for the presentation to report recipients will not allow any modification of the presentation.
1.3 Motivation
Significant developments in computer hardware, software and data communications used in Healthcare have
taken place in the last few years. In particular, it is now possible to incorporate the results of Healthcare
Procedures such as images and Curves within electronic reports, possibly using multimedia facilities. Systems
can be implemented at reasonable cost using World Wide Web Technology and there is considerable interest in
this area, which will impact on the Electronic Patient Record as well as the diagnostic imaging department.
It is believed that a review of the specific medical needs for multimedia reports and evaluation of existing and
draft standards for use in this area will assist the healthcare informatics standards community in further
standards development. A review will, in particular, help TC 251 in enabling the healthcare community to gain
maximum benefit from the emerging technology.
From the standards development point of view, it is important to exploit the use of appropriate standards and to
identify areas where more work is required to enable interoperability of systems.
In assessing the clinical requirements for healthcare multimedia reports and how these could be met, major
problems exist. These are:
• There is no clear agreement about what a healthcare multimedia report is
•
Implementations are rare
• Technologies develop rapidly
•
Inadequate standards and specifications lead to interoperability problems.
1.4 Aims and Objectives

1.4.1 Aims
In addressing the problems listed above, this CEN Report aims to facilitate Interoperability of Healthcare
Informatics Systems that support the use of Multimedia information. The report focuses on Healthcare
(Procedure) multimedia reports such as Radiological procedure reports within the clinical process by:
a) identifying the needs for their implementation, and
b) reviewing existing and emerging standards and specifications in the light of the identified clinical needs, and
c) considering the requirements for further standardisation activities
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1.4.2 Objectives
The overall objective is to make recommendations to CEN/TC 251 regarding future standards work required to
enable the interoperability of Healthcare Multimedia systems for the creation, modification and presentation of
healthcare multimedia report records, taking account of existing standards and existing and emerging
technologies.
This CEN report has the following specific objectives:
Healthcare Multimedia Report: To define and explain the term Healthcare Multimedia Report (HCMR) in the
context of this CEN Report.
Interoperability: To define and explain the term Interoperability in the context of this report
Healthcare Procedure Scenarios: To inform healthcare informaticians by documenting Scenarios of Healthcare
Procedures such as diagnostic imaging procedures and intensive monitoring, illustrating the use of Imaging and
other Medical Devices in the acquisition and processing of acquired patient data.
Healthcare Procedure Data: To describe the nature of the acquired and processed data produced by
Healthcare Procedures. This will allow precise specification of the processes necessary for multimedia
presentation of these data.
Healthcare Service Reports: To document scenarios of the production, recording and subsequent presentation
of Healthcare Service Reports, with and without the use of multimedia facilities.
Healthcare Procedure Report Data: To discuss the nature of the data required to specify the presentation of a
Healthcare Multimedia Report. Note that it is not intended to prescribe the method of presentation.
Unified Modeling Language Modelling: To develop Unified Modeling Language (UML) conceptual models
based on the above scenarios.
Review of existing standards: To examine current relevant standards and determine to what extent they
support the needs identified in this CEN Report.
Recommendations: To make recommendations regarding work required to improve interoperability of
multimedia report systems, including recommendations for the extension of existing standards/specifications and
the development of new standards/specifications.
1.5 Method of Work

1.5.1 Traditional Healthcare Service Report Scenarios
Scenarios of the creation and use of Healthcare Service Reports such as Radiological Reports were produced.
These take into account the existing scenarios documents of CEN/TC 251/WG4 and CEN/TC 251/WG5 and the
knowledge and experience of the medically qualified healthcare professional member of this CEN Report Project
Team and views of various workers in the field. A scenario describes the processes that take place in the
relevant domain and identifies the human actors, real world entities and logical data structures involved.
1.5.2 Scenarios of healthcare multimedia reports
Viable means for the clinical use of Multimedia Reports were identified:
1.5.3 Multimedia report use cases
Use cases of the creation, amendment and use of multimedia reports were produced based on the two related
scenarios sections. These utilise both a textual format and diagrams to illustrate the sequence of events in a
process showing how human actors, system facilities and logical data structures relate to each other.
1.5.4 Conceptual Modelling
Formal Unified Modeling Language (UML) conceptual models were derived from the use cases.
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These high-level abstractions are also represented using UML system sequence diagrams. A system sequence
diagram provides a model of a particular course of events within a use case where it is demonstrated how
human actors interact with physical entities and multimedia entities and the events that are generated from this
interaction. Use case and sequence diagrams are used to further derive a formal UML conceptual model (that is
a representation of concepts of entities in the problem domain) using UML class diagram notation.
1.5.5 Logical data structures
The characteristics of a Healthcare Procedure Product logical data structure to support the forms of acquired and
processed data covered by the scope of CEN/TC 251 WGIV are described at the end of section 8.
The characteristics of logical data structures for describing the Multimedia presentation of a specific set of
Healthcare Procedure Product logical data structures are discussed in section 9.
1.5.6 Assessment of the applicability of relevant existing and emerging Standards and Specifications

The applicability of multimedia and other existing and emerging standards/specifications to support the identified
requirements was assessed as a guide to the needs for further work.
1.5.7 Recommendations for use and/or extension of standards and Publicly Available Specifications

Recommendations are made for the use of (and possible extensions to) multimedia standards to serve the
identified clinical needs. Areas where standards are lacking are identified, and need for further work items
highlighted.
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2 SCOPE
The scope includes issues concerning the interoperability of systems for the creation, modification and
presentation of digital healthcare multimedia report records as described in the Introduction.
This CEN report concentrates on a limited set of multimedia documents, namely reports such as those of
Diagnostic Imaging and Vital Signs studies. This set of documents constitutes a representative sample of
complex healthcare multimedia reports within the scope of CEN/TC 251/WGIV. It is expected that the
recommendations, which take into account this complexity, will support the management of less complex reports.
This CEN report has three main parts:
• Identification and modelling of the needs for interoperability of multimedia systems for the creation,
modification and presentation of Healthcare Service Reports.
• Assessment of the applicability of appropriate existing and emerging standards and Publicly Available
Specifications as at November 1998.
• Recommendations for the use and/or extension of Standards and Publicly Available Specifications.
The scope does not include the creation of implementable specifications or complete requirement specifications.
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3 REFERENCES AND BIBLIOGRAPHY
3.1 References
ENV 13734:2000 Health informatics - Vital Signs Information Representation. (VITAL)
Extensible Biosignal Format, University of Erlangen, Germany,. http://www.ipb.uni-
erlangen.de/biokybernetik/biokyberneti
...