DD Env 12018-1998
DD Env 12018-1998
12018:1998
Identification,
administrative, and
common clinical data
structure for
Intermittently
Connected Devices
used in healthcare
(including machine
readable cards)
National foreword
Summary of pages
This document comprises a front cover, an inside front cover, pages i and ii,
the ENV title page, pages 2 to 91 and a back cover.
This standard has been updated (see copyright date) and may have had
amendments incorporated. This will be indicated in the amendment table on
the inside front cover.
© BSI 06-1999
Contents
Page
National foreword Inside front cover
Foreword 2
Text of ENV 12018 5
© BSI 06-1999 i
ii blank
EUROPEAN PRESTANDARD ENV 12018
PRÉNORME EUROPÉENNE
October 1997
EUROPÄISCHE VORNORM
Descriptors: Medicine, data processing, information interchange, data transmission, data, organization of data
English version
CEN
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung
Central Secretariat: rue de Stassart 36, B-1050 Brussels
© 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national
Members.
Ref. No. ENV 12018:1997 E
ENV 12018:1997
Foreword Page
[Link] The “Place” data object 13
This European Prestandard has been prepared by
[Link] The “Telecommunication” data object 13
Technical Committee CEN/TC 251 “Medical
informatics”, the secretariat of which is held by SIS. [Link] The “Telephone Numbers” data object 13
This European Prestandard has been prepared [Link] The “X.400” and “Other Network
under a mandate (BC-IT-217) given to CEN by the Addresses” data objects 13
European Commission and the European Free [Link] The “Money” data object 13
Trade Association, and supports essential 6.3 Basic data objects 13
requirements of EU Directive(s).
6.3.1 Record persons 13
According to the CEN/CENELEC Internal
Regulations, the national standards organizations [Link] The “Record Persons” data object 13
of the following countries are bound to announce [Link] The “Record Person” data object 14
this European Prestandard: Austria, Belgium, [Link] The “Major Record Identifier” data
Czech Republic, Denmark, Finland, France, object 14
Germany, Greece, Iceland, Ireland, Italy, [Link] The “Alternative Record Identifiers”
Luxembourg, Netherlands, Norway, Portugal, data object 15
Spain, Sweden, Switzerland and the
United Kingdom. [Link] The “Record Identification
Verification” data object 15
Contents 6.3.2 The “Device Specific Data” object 15
Page [Link] The “Device Type” data object 15
Foreword 2 [Link] The “Device Class” data object 15
Introduction 5 [Link] The “Device Standard” data object 15
1 Scope 6 [Link] The “Device Specifications” data
object 15
2 Normative references 6
[Link] The “Device Applications” data
3 Definitions 7 object 15
4 Abbreviations 10
[Link] The “Device Specific Directory”
5 Basic data object model for an ICD 10 data object 16
5.1 Object structure 10 [Link] The “Device Identification” data
5.2 Linking 11 object 16
6 Basic data objects for referencing 11 6.3.3 Objects linking sites and persons 16
6.1 Overview 11 [Link] The “Healthcare Sites” data object 16
6.2 Generally useful types used for [Link] The “Healthcare Persons” data
implicit definitions 11 object 16
6.2.1 Person name related data objects 12 [Link] Linking of sites and healthcare
[Link] The “Full Name” data object 12 persons: the “Site Mix Table” data
object 16
[Link] The “Title” data object 12
6.3.4 Coded data 17
[Link] The “Surname Prefix” data object 12
[Link] The “CodingSchemesUsed” data
[Link] The “Surnames” data object 12 object 17
[Link] The “Surname” data object 12 [Link] The “CodedData” data object 17
[Link] The “Forenames” data object 12 6.3.5 Attributes 17
[Link] The “Forename” data object 12 [Link] Accessory attributes 17
[Link] The “Name Element” data object 12 [Link] Device and data security attributes 18
6.2.2 Address and telecommunication 6.4 Link associations between objects 19
related data objects 12
6.4.1 The “RecordPersonPointer” data
[Link] The “Postal Address” data object 12 object 19
[Link] The “Post Code” data object 12 6.4.2 The “ReferencePointer” and
[Link] The “Country” data object 12 “ReferenceTag” data objects 19
[Link] The “Date” data objects 13 6.4.3 The “Linkages” data object 19
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6.5 Data from ICDs held by healthcare 9 Specific ICDs security services
persons 20 related data objects 27
7 Basic identification and 9.1 Patient devices security related data 27
administration data 20 9.2 Healthcare persons devices security
7.1 The “Variable Identification Data” related data 27
object 20 9.2.1 Healthcare persons access keys: the
7.1.1 The “Address” data object 20 “PatientICDAccessData” data object 27
7.1.2 The “Record Person Telecom” data 9.2.2 Healthcare persons authentication
object 20 key: the “IdAuthenticateData” data
7.1.3 The “Preferred Languages” data object 27
object 20 9.2.3 Healthcare persons signature
7.1.4 The “Maiden Name” data object 21 key: the “HCPSignFuncData”
data object 28
7.1.5 The “Previous Surnames” data
object 21 9.2.4 Healthcare persons authentication
and signature public keys and
7.1.6 The “Other Names” data object 21
certificate 28
7.2 The “Record Person Post Code” data
9.2.5 Object related security reference
object 21
data 28
7.3 The “Record Person Country” data
9.3 The “SecurityAttributes” data object 28
object 21
Annex A (informative) General points
7.4 The “Contact Persons” data object 21
about ASN.1 data objects representation 29
7.5 The “Record Person Visiting
A.1 ASN.1 definitions 29
Instructions” data object 21
A.2 ASN.1 syntax 30
7.6 The “Payment Provisions” data
object 22 A.3 The Tag-Length-Value format 31
7.7 The “Patient Payments” object 23 A.4 The use of tags 31
7.8 The “Other Coded Administrative A.5 Examples of using the Basic
Data” object 23 Encoding Rules for use with ASN.1
for objects in this standard 31
8 Clinical data 23
Annex B (normative) ASN.1 representation
8.1 The “Clinical Coded Data” object 23
of data objects in this European Prestandard 32
8.2 The “Parameter” data objects 23
B.1 Basic Data Objects for Referencing 32
8.2.1 The “Medication Note” parameter
B.1.1 Person Name related data objects 32
object 23
B.1.2 Address and Telecommunication
8.2.2 The “Medication Prescription”
related data objects 33
parameter object 24
B.1.3 The “Money” data object 33
8.2.3 The “Medication Administered”
parameter object 24 B.2 Basic Data Objects 33
8.2.4 The “Medication Dispensed” B.2.1 The “Record Persons” data object 33
parameter object 25 B.2.2 The “Major Record Identifier” data
8.2.5 The “Drug Sensitivity” parameter object 34
object 25 B.2.3 The “Alternative Record Identifiers”
8.2.6 The “Laboratory Test Results” data object 34
parameter object 25 B.2.4 The “Record Identification
8.2.7 The “Digital Binary Data” Verification” data object 35
parameter object 26 B.3 The “Device Specific Data” object 35
8.2.8 The “Request” parameter object 26 B.3.1 The “Device Data” object 35
8.2.9 The “Diagnosis” parameter object 26 B.3.2 The “Device Type” data object 35
8.2.10 The “Procedures” parameter object 26 B.3.3 The “Device Applications” data object 35
8.3 The limited emergency data set 26 B.3.4 The “Device Specific Directory”
data object 35
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B.3.5 The “Device Identification” data B.20.2 The “Medication Prescription”
object 36 parameter object 44
B.4 The “Healthcare Sites” data object 36 B.20.3 The “Medication Administered”
B.5 The “Healthcare Persons” data parameter Object 45
object 36 B.20.4 The “Medication Dispensed”
B.6 Linking of sites and healthcare parameter object 45
persons: the “Site Mix Table” data B.20.5 The “Drug Sensitivity” parameter
object 37 object 46
B.7 Coded data and coding schemes 37 B.20.6 The “Laboratory Test Results”
B.7.1 The “Coding Schemes Used” data parameter object 46
object 37 B.20.7 The “Digital Binary Data”
B.7.2 The “Coded Data” data object 37 parameter object 47
B.8 The “Accessory Attributes” data B.20.8 The “Request” parameter object 47
object 37 B.20.9 The “Diagnosis” parameter object 47
B.9 Link associations between objects 38 B.20.10 The “Procedure” parameter object 47
B.9.1 The “Record Person Pointer” data B.21 The Limited Emergency Data Set 47
object 38 B.22 Specific ICDs security services
B.9.2 The “Reference Pointer” and related data objects 48
“Reference Tag” data objects 39 B.22.1 Patient devices security related data 48
B.9.3 The “Linkages” data object 39 B.22.2 Healthcare persons devices
B.10 Data from ICDs held by security related data 49
healthcare persons 39 Annex C (informative) The hierarchy of
B.11 Basic ID & Administration Data 39 data objects 51
B.11.1 The “Address” data object 39 C.1 Basic data objects for referencing 51
B.11.2 The “Record Person Telecom” C.2 Basic data objects for identification
data object 39 and administrative purposes 54
B.11.3 The “Preferred Languages” data C.3 Clinical data 57
object 40 C.4 Specific ICDs security services
B.11.4 The “Maiden Name” data object 40 related data objects 59
B.11.5 The “Previous Surnames” data Annex D (normative) Application specific
object 40 data object tags and their values 60
B.11.6 The “Other Names” data object 40 Annex E (informative) Devices that may
B.12 The “Record Person Post Code” function as Intermittently Connected Devices 60
data object 40 Annex F (informative) Data Dictionary 61
B.13 The “Record Person Country” data F.1 Data types 62
object 40 F.2 Status of the attributes within
B.14 The “Contact Persons” data object 40 the objects 62
B.15 The “Record Person Visiting Annex G (informative) EDIFACT
Instructions” data object 41 representation of a sample of data objects 82
B.16 The “Payment Provisions” data Table F.1 — Data dictionary 63
object 41 Table G.1 — Data dictionary illustration 86
B.17 The “Patient Payments” data object 43 Table G.2 — EDIFACT message
B.18 The “Other Coded Administrative representation between CAD and host 90
Data” object 43
B.19 The “Clinical Coded Data” object 43
B.20 The “Parameter” data objects 44
B.20.1 The “Medication Note” parameter
object 44
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Introduction
With a more mobile population, greater healthcare delivery in the community and at patients’ homes,
together with a growing demand for improved quality of ambulatory care, portable information systems
and stores have increasingly been developed and used. Such devices are used for tasks ranging from
identification, through portable medical record files, and on to patient-transportable monitoring systems.
The functions of such devices are to carry and to transmit person-identifiable information between
themselves and other systems; therefore, during their operational lifetime they may share information
with many technologically different systems which differ greatly in their functions and capabilities.
Healthcare administration increasingly relies upon similar automated identification systems too. For
instance prescriptions may be automated and data exchange carried out at a number of sites using patient
transportable computer readable devices. Healthcare insurers and providers are increasingly involved in
cross-region care, where reimbursement may require automated data exchange between dissimilar
healthcare systems.
The advent of remotely accessible data bases and support systems has led to the development and use of
“Healthcare Person” identification devices that are also able to perform security functions and transmit
digital signatures to remote systems via networks.
With the growing use of intermittently connected devices for practical everyday healthcare delivery, the
need has arisen for a standardised data format for interchange.
The data carried by an ICD can be categorised in three broad types: identification, administrative and
clinical.
Identification data may include:
— identification of the device itself;
— unique identification of the device holder or of all other persons to whom the data carried by the device
are related.
Administrative data may include:
— complementary person(s) related data;
— identification of the funding of health care, whether public or private, and their relationships
i.e. insurer(s), contract(s) and policy(ies) or types of benefits;
— other data (distinguishable from clinical data) that are necessary for the purpose of healthcare
delivery.
Common clinical data may include:
— items that provide information about health and health events;
— their appraisal and labelling by a Healthcare Provider (HCP);
— related actions planned requested or performed;
— the outcome of such actions (e.g. in terms of tests results).
Because there exists a need to optimise the use of memory by avoiding redundancies, and also because an
ICD essentially provides specific answers to definite queries, “high level” Object Modelling Technique
(OMT) has been applied with respect to ICDs data structure.
Data in the three categories above share many features. For instance, each may need to include ID
numbers, names and dates. Some information may also have clinical as well as administrative uses.
Therefore it has been considered inadequate to provide a simple list of items carried by ICDs without
applying a generic organisation, based upon the existence of basic data elements. These may be defined by
their characteristics (e.g. their format), and from them compound data objects may be constructed; several
such objects may also share attributes.
This European Prestandard describes the data objects using plain text in normative clauses 6, 7, and 8.
Clause 6 defines basic data objects for referencing.
Clause 7 defines objects for:
— administrative data to allow identification of patient or of healthcare persons (professionals and other
types of personnel) and of records belonging to them;
— demographic and general administrative data.
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Clause 8 defines objects for clinical data interchange requirements, with special emphasis on coded data.
Annex A gives general information about the ASN.1 syntax.
Annex B, Annex C, and Annex D (normative) provide a representation of all objects using ASN.1 notation
with the corresponding tags, whilst Annex F provides a data dictionary, and Annex G (informative) an
EDIFACT representation of a sample of data objects.
1 Scope
This European Prestandard establishes a common framework for the content and the structure of
identification, administrative and common clinical data. It applies exclusively to situations in which such
data are recorded on or transported by Intermittently Connected Devices (ICDs) which are intended for use
in healthcare.
This European Prestandard specifies the basic structure of the data, but does not specify particular
data-sets for storage on devices.
To allow interoperability, whenever an application is built for use in the healthcare domain in compliance
with this European Prestandard, data items required for that application shall be drawn from the list of
objects (some of which are extensible) as provided in clauses 6 to 8. The detailed functions and mechanisms
of the following services are not within the scope of this European Prestandard, (although its structures
can accommodate suitable data objects elsewhere specified):
— security functions and related services which are likely to be recommended for ICDs depending on
their specific application, for example: confidentiality protection, data integrity protection, and
authentication of persons and devices;
— access control services which may depend on active use of some ICD classes such as microprocessor
cards;
— the initialisation and issuing process (which begins the operating lifetime of an individual ICD, and
by which the ICD is prepared for the data to be subsequently communicated to it according to this
European Prestandard).
Data is extracted from an ICD in the form of a “message”. This European Prestandard addresses the
“meaning” of the message within or at the interface between an ICD and an application system, not the
“method” of its origination or transmission.
The following topics are therefore beyond the scope of this European Prestandard:
— physical or logical solutions for the practical functioning of particular types of ICDs;
— how the message is processed further “downstream” of the interface between two systems;
— the form which data takes for use outside the ICD, or the way in which such data is visibly represented
on the ICD or elsewhere.
2 Normative references
This European Prestandard incorporates, by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of
these publications apply to this European Prestandard only when incorporated in it by amendment or
revision. For undated references the latest edition of the publication referred to applies.
ENV 1068:1993, Medical informatics — healthcare information interchange — Registration of coding
schemes.
EN 1387, Machine readable cards — Health care applications — Cards: General characteristics1).
EN 23166:1994, Codes for the representation of names of countries.
EN 27816-3:1992, Identification cards — Integrated circuit(s) cards with contacts — Part 3: Electronic
signals and transmission protocols.
EN 28601:1992, Data elements and interchange formats — Information interchange — Representation of
dates and times.
ISO 639:1988, Codes for the representation of names of languages.
1)
At present at the stage of draft.
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3 Definitions
For the purposes of this European Prestandard, the following definitions apply.
3.1
alternative record identifier
an alternative record identifier is an identifier, composed of characters, that is not identical to the major
record identifier and is related to the same record person
3.2
asymmetric authentication method
method for demonstrating knowledge of a secret, in which not all authentication information is shared by
both entities
3.3
confidentiality
the property that information is not made available or disclosed to unauthorised individuals, entities or
processes. [ISO 7498-2:1989]
3.4
country
the code that identifies the country of origin of the device issuer
NOTE This may not necessarily be the same as the nationality of the device holder.
3.5
cryptographic key
parameter used, in conjunction with an algorithm, for the purposes of validation, authentication,
encipherment, or decipherment. [ISO 8908:1993]
2)
At present at the stage of draft.
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3.6
cryptography
the discipline which embodies principles, means, and methods for the transformation of data in order to
hide its information content, prevent its undetected modification and/or prevent its unauthorised use.
[ISO 7498-2:1989]
3.7
data integrity
the property that data has not been altered or destroyed in an unauthorised manner [ISO 7498-2:1989]
3.8
data object
a data object is a collection of data that has a natural grouping and may be identified as a complete entity
3.9
data origin authentication
the corroboration that the source of data received is as claimed [ISO 7498-2:1989]
3.10
data sub-object
a data sub-object is a component of a data object that itself may be identified as a discrete entity
3.11
device holder
a device holder is an individual transporting an ICD which contains a record with themselves identified as
the major record person
3.12
digital signature
data appended to, or a cryptographic transformation of, a data unit that allows a recipient of the data unit
to prove the source and integrity of the data unit and protect against forgery e.g. by the recipient
[ISO 7498-2:1989]
3.13
entity authentication
the corroboration that an entity is the one claimed [ISO/IEC 9798-1:1991]
3.14
erasure
the process whereby access to a data entity after a given point in time is permanently removed or access
denied thereafter to all parties
NOTE This may not involve physical removal from the device, and may merely be the result of altering security such that access is
permanently denied to all parties.
3.15
healthcare person device
an HCP device is designed to provide the function of allowing healthcare persons to have their identity and
qualifications acknowledged by the information systems that they use, including informatics and
telematics, and if necessary, to sign the transactions that they perform via these systems
3.16
ICD application system
an application system that can communicate with an ICD
3.17
ICD connecting unit
a physical device, which may also contain software elements, that enables communication to take place
between an ICD and a host
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3.18
interface
may be both physical or electrical or logical. A hypothetical junction between an ICD and the external
environment
NOTE This term can be used with a qualifier to describe an attribute to allow data flow to take place over this hypothetical point.
3.19
intermittently connected device (ICD)
an Intermittently Connected Device:
a) stores person related information in computer readable format; and
b) supports data interchange; and
c) when used for data interchange does not require that the originator of the information receives
“confirmation of receipt” of the information”.
NOTE Many different types of hardware may be ICDs but it is important that being an ICD according to this definition is never an
intrinsic aspect of the device itself but is dependant upon a certain usage. An ICD may have several uses and hardware functions
other than the storage and transmission of person related data.
3.20
linkage
the ability to join together two or more entities or parts. It may be physical, electrical or relational
3.21
major industry identifier (MII)
the code that identifies the sector/industry within which the ICD is intended for use
3.22
major record identifier
the major record identifier is an identifier linked to a primary record relating to a record person within an
ICD and a given healthcare delivery system
3.23
personal identification number (PIN)
the PIN is a 4 to 12 character alphanumeric code or password the device holder possesses for the purposes
of authentication
3.24
record
a record is a collection of data
3.25
record person
a record person is an individual about whom there is an identifiable record containing person related data
3.26
security
the combination of confidentiality, integrity and availability
3.27
soft network
a logical form of linkage in which message sender and recipient are not physically linked and in which
message receipt confirmation may not be received by sender
3.28
update
the process whereby information is erased and replaced by new information
3.29
write
the process whereby information is added to the ICD
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4 Abbreviations
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5.2 Linking
A number of objects in the data model of this European Prestandard are used mainly as a reference to other
objects. One example is the RecordPerson that defines the basic identification information of a person to
whom records on the device relate. Since this is a part of an aggregate object containing information on all
record persons in a sequential order, the pointer may be a simple one-dimensional integer number. This
type of pointer has the name RecPersPointer and is used extensively to indicate the record person to whom
a certain information object is related.
In other situations, constructed objects contain a more general pointer called a RefPointer that is a
sequence of tags allowing a reference to any object, including sub-objects that can only be referenced as part
of a constructed object, using an application specific tag and a number of context specific tags to sufficient
depth.
A RefPointer to the name of a healthcare person may contain the following information with the
appropriate tags (here represented by their symbolic names):
HealthCarePersons [7]HealthCarePerson no 7 [1] HcpName
Application tag Context level 1 Context level 2
All administrative and clinical Coded data items have Accessory attributes. These data objects contain
information on when, where and who recorded data. They allow specification of security services and
parameters. If security requirements permit, such data objects may be associated with several objects.
There is also a third possibility that allows the creation of linkages between all objects using the Linkages
object (see further in clause 11.4). This is an ordered list of link associations. All entries in this list are a
sequential list of other objects, each defined with a RefPointer.
EXAMPLE: Link no 2 may link four objects
1:
2: RefPointer1 RefPointer2 RefPointer3 RefPointer4
3:
An example of this process could be the linkage of the following objects as defined in clause B.20.
Diagnosis — RefPointer1
MedicationPrescription — RefPointer2
MedicationNote — RefPointer3
MedicationDispensed — RefPointer4
This linkage table entry may be pointed to by the ClinRefPointer of each ClinDat object.
NOTE Even though the Link object itself is openly available, the linked objects may have restricted access.
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The “RecordPersons” data object shall consist of a sequence of “RecordPerson” data objects. A “Major
Record Person” shall always be designated. In addition there may be any number of other Record Persons.
Thus the “Major Record Person” shall be followed by a choice of other Record Persons (spouse, child, father,
mother, other person). Each of these “RecordPerson” data objects shall be constructed as defined in
clause [Link].
The ASN.1 representation of these data objects is provided in Annex B, clause B.2.1.
NOTE When the device is a card, the Major Record Identifier of the Major Record Person, is also the Major Identifier for the device;
in such a case it will therefore always be present as visible data on the outside of the card.
[Link] The “Record Person” data object
The purpose of this object is to allow for record linkage to be performed. The object may also be used to
provide identification information. When the device is a card, the major record identifier of the major record
person will always be present as visible data on the outside of the card if following the scheme standardised
within EN 1387.
The “Record Person” data object shall consist of a set of a “Major Record Identifier”, of optional “Alternative
Record Identifiers”, and of a “Record ID Verification” data objects.
The ASN.1 representation of these data objects is provided in Annex B, clauses B.2.1 to B.2.4.
[Link] The “Major Record Identifier” data object
The “Major Record Identifier” data object shall be constructed as a sequence of components. These
components shall consist of the Major Industry Identifier (MII), the issuer country, the issuer identifier, a
check digit, and a record ID number.
The healthcare sector indicator (“Major Industry Identifier”, or MII) shall consist of a 2 characters long
Numeric String. The default value shall be 80 as already allocated to the health sector.
The “Issuer Country” code shall be three characters numeric coded data as defined according to
EN 23166:1994 in clause [Link] (“Country” data object).
The “Issuer Identifier” shall be a five character numeric code as allocated to all card issuers when the ICD
is in the form of a card. This issuer code shall be allocated by a nationally appointed registration authority.
A “Check Digit” shall be calculated on the foregoing three code values according to the Luhn modulus ten
double-add-double check digit formula.
The “Record ID Number” shall be constructed according to the “Evolutionary Record Identifier” data object
defined below. The evolutions of the record identifier are intended to provide for the existence of any format
of identifier whilst preserving the migration of identifiers towards integrated systems.
A “Record ID Number” shall consist of:
— a transitional sequence identifier consisting of a single integer defined as an “Evolutionary Record
Identifier”. This data object indicates the phase of evolution of the numbering system and value. Thus
identifiers can appear in three possible types. But all such record ID numbers when undergoing future
structural change shall transfer to the all numeric format;
— the “Evolutionary Record Identifier” data object shall consist of a choice of three octet strings
(Evolution1, Evolution2, and Evolution3).
“Evolution1” type defines a free format alphanumeric record identifier, with any form of separator,
and a maximum number of characters of 27.
“Evolution2” type defines a record identifier that has only alphanumeric characters and a single
form of separator being a forward slash (/). Its maximum number of characters is 27.
“Evolution3” type defines a RecordIdentifier that is all numeric with no separators and a maximum
number of characters of 27.
NOTE 1 The evolutions of the RecordIdentifier are intended to provide for the existence of any format of Identifier whilst preserving
the migration of identifiers towards integrated systems. These evolutions are “tagged” and thus identified, so that records relating to
an individual may be identified by more than one type of identifier within a given healthcare delivery system. This concept is distinct
from the facility provided within alternative record identifiers (see clause [Link]).
NOTE 2 In the case of an ICD in the form of a card the Evolutionary Record Identifier shall be the card holder identification number
as defined in EN 1387.
The ASN.1 representation of this data object and its components is provided in Annex B, clause B.2.2.
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The “DevApplicationCodes” object shall consist of a set of coded data objects as defined in clause [Link].
The ASN.1 representation of these data objects is provided in Annex B, clause B.3.3.
[Link] The “Device Specific Directory” data object
The application specific tags of the objects stored on the device shall be contained in a separate object that
will be unprotected by any subsidiary security functions. This data object shall consist of a set of reference
tags (RefTag) related to the addressable objects available on the device. It shall not convey any other
meaning.
The object RefTag is defined in clause 6.4.2.
The ASN.1 representation of this data object is provided in Annex B, clause B.3.4.
[Link] The “Device Identification” data object
The object “Devidentification” shall provide the identification of the individual device and the various
parties involved in its manufacturing and issuing. It shall consist of coded data to represent the device
manufacturer, coded data to represent the device component manufacturer, coded data to represent the
personaliser of the device, a unique device serial number and the issuing date of the device.
The object “DevIdentification” shall be constructed as a set of sub-objects “deviceManufacturer”,
“deviceComponentManuf”, “devicePersonaliser”, deviceIdNo”, and “deviceActivationDate”.
The objects “deviceManufacturer”, “deviceComponentManuf”, and “devicePersonaliser” shall consist of
CodedData objects, as defined in clause [Link].
The object “deviceIdNo” shall consist of an octet string with a length comprised between 1 and 21
characters.
The optional object “deviceActivationDate” shall consist of a Date object, as defined in clause [Link] above.
The ASN.1 representation of these data objects is provided in Annex B, clause B.3.5.
6.3.3 Objects linking sites and persons
[Link] The “Healthcare Sites” data object
The “Health Care Sites” data object shall consist of a reference table of sites which are associated with
healthcare personnel who have recorded data on the device.
The “HealthCareSites” data object shall be constructed as a sequence of the sub-object “HeathCareSite”.
This data object “HealthCareSite” itself shall be constructed as a set of sub-objects “hcsCountry” (of
“Country” type), “hcsId” (a numeric string with a length of between & and 21 characters), “hcsName” (an
octet string of 15 characters), “hcsAddr” (of “Address” type), “hcsType” (CodedData), and “hcsTelecom” (of
“Telecom” type).
The ASN.1 representation of these data objects is provided in Annex B, clause B.4.
[Link] The “Healthcare Persons” data object
The “Healthcare Persons” data object shall contain a list of all healthcare persons (professionals and type
of personnel that have performed healthcare) recorded on the ICD or added data to it.
The “HealthCarePersons” data object shall consist of a sequence of the sub-object “HealthCarePerson”.
The data object “HealthCarePerson” itself shall be constructed as a set of “hcpCountry” (of “Country” type),
“hcpIdNo” (a numeric string with a length between 1 and 21 characters), “hcpName” (of “Fullname” type),
optionally “hcpRelationCode” (of “CodedData” type, a code that would indicate things like primary
responsible general practitioner, specialist, consultant, etc.), “hcpClass” (a sequence of booleans described
hereafter), optionally “hcpProfession” (a sequence of “hcpProfCode”, in order to allow for national codes
linking to exact definitions of various HCP groups), optionally “hcpEmploymentNo” (of BitString type),
optionally “hcpEmploymentData” (a sequence of “CodedData”).
The object “hcpClass” shall consist of a sequence of booleans indicating professions (doctor, dentist,
pharmacist, midwife, nurse, admin., professions allied to medicine, professions allied to dentistry,
professions allied to pharmacy, professions allied to nursing).
The ASN.1 representation of these data objects is provided in Annex B, clause B.5.
[Link] Linking of sites and healthcare persons: the “Site Mix Table” data object
The “SiteMixTable” data object provides the function of allowing multiple HCPs to be present at one site
or one HCP to be present at multiple sites without having the necessity of having duplicated data.
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The “SiteMixTable” data object shall consist of a sequence of “SiteMix” objects, each consisting of “HCSRef”
and “HCPRef” reference pointers pointing respectively at “HealthCareSites” and “HealthCarePersons”.
The ASN.1 representation of these data objects is provided in Annex B, clause B.6.
6.3.4 Coded data
Coded values are understood by reference to the coding scheme to which they apply. The general principle
in this European Prestandard is that it is not mandatory to use a particular coding scheme, unless
specified within this European Prestandard, when such codes act as parameters. One example is the
use of EN 23166:1994 for country codes.
When a coding scheme is exclusively specified within this European Prestandard no alternative coding
scheme shall be allowed. Any references to coding schemes not so specified may however be modified in the
future independent of the rest of the standard.
[Link] The “CodingSchemesUsed” data object
Coding schemes not specified within this European Prestandard may themselves be the subject of a
registration within the coding schemes procedure as defined in ENV 1068:1993 and shall then be
interpreted, if at all, in accordance with all conditions of that registration.
ENV 1068:1993 specifies a procedure for registration of coding schemes and the allocation of a healthcare
coding scheme designator (HCD). It is possible to reference both internationally registered coding schemes
and unregistered coding schemes as defined in clause 5 of ENV 1068:1993. The use of such private
CodeIdentifiers may however create the potential risk of ambiguity if a device should be used in an open
environment.
Code values from unregistered schemes (or registered schemes outside the scope of a particular
application) cannot be understood, unless the recipient of information is party to an agreement with the
originator to use additional or non registered coding schemes.
The data object “CodingSchemesUsed” shall consist of an ordered sequence of the sub-object
“CodingScheme”, which shall itself consist of a code identifier (an octet string of 6 characters), a code length
(of integer type), and an optional free text comment (an octet string with a length of between 1
and 20 characters).
The ASN.1 representation of this data object is provided in Annex B, clause B.7.1.
[Link] The “CodedData” data object
The data object “CodedData” shall include both a reference to coding schemes used and a code data value
as well as optional free text and shall be constructed as a set of the sub-objects “codingSchemeRef”,
“codeDataValue”, and optionally “codeDataFreeText”.
The object “codingSchemeRef” is a Ref Pointer pointing at a value that identifies a particular coding scheme
within the object coding schemes used. If CodingSchemeRef = 0 then the coding scheme is implicit in this
standard.
The data type “codeDataValue” has been defined to indicate the actual code value in a particular coding
Scheme. The length of “codeDataValue” is one OCTET and the following codeDataValues are
defined: “A” means “Administrative free text entry”, “C” means “Clinical free text entry”.
The ASN.1 representation of this data object is provided in Annex B, clause B.7.2
6.3.5 Attributes
[Link] Accessory attributes
The data object “AccessoryAttributes” shall consist of an ordered set of data that is essential to record an
audit trail regarding both the originator of the information and the means via which it arrives to the
recipient. It shall consist of:
Date1 which shall represent the time/date of data being communicated to the ICD across the interface;
Date2 which shall represent the time/date of data being available to the originator of the message;
Place1 which shall represent the identity/locator of the sender of the message and is linked with
“person1”;
Place2 which shall represent the identity/locator of the original author of the data;
Personid3 shall be either the code or representation of the person/device/system that provided the
information that was added to a system to become the data within the “message”;
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SecurityLevels which shall be constructed according to the ASN.1 definition contained in B.8 and shall
represent the rights in relation to reading, writing, updating and erasing the data contained within the
data object to which these accessory attributes are attached.
CompressionMethodData shall be constructed according to the ASN.1 definition contained in B.8 and
shall consist of a ref pointer pointing at a defined compression methodology within a compression
methodology table. This represents the methodology applied to the data contained within the data
object to which the accessory attributes are attached.
Object security attributes.
The “AccessoryAttributes” data object shall be constructed as a set of the following optional data objects:
— “date1” and “date2” (of “Date” type);
— “place/Person1” and “place/Person2” (of “RefPointer” type);
— “personId3” (a set of “PersonCode” of RefPointer type, and free “PersonText” with a length of up
to 30 characters);
— and of “ObjectSecAttributes” (a set of “SecurityServices”).
The data objects “SecurityServices” shall each consist of a sequence of digital signatures, as well as
algorithms and keys for signature and encryption.
None of the above attributes is mandatory, however all are highly desirable. It is recommended that all
(with the possible exception of Personid3) should be delivered every time that the media/system allows. A
list of priorities in groupings follows and in principle should be followed as groups:
{Date1,Date2,Place1,Place2,Personid3,SecurityLevels, CompressionMethodData,ObjSecAttributes}
{Date1,Place1,Place2, SecurityLevels, CompressionMethodData,ObjSecAttributes}
{Date1,Place1,Place2, SecurityLevels, CompressionMethodData,ObjSecAttributes}
{Date1,Place2, SecurityLevels, CompressionMethodData,ObjSecAttributes}
{Date1, SecurityLevels, CompressionMethodData,ObjSecAttributes}
{SecurityLevels, CompressionMethodData,ObjSecAttributes}
{ObjSecAttributes}
NOTE This “AccessoryAttributes” data object can be associated to any other data object.
The ASN.1 representation of this data object is provided in Annex B, clause B.8.
[Link] Device and data security attributes
Data stored in intermittently conected devices in health care may be personally sensitive. For this reason
this European Prestandard provides a series of security attributes in the form of data objects that may be
required for the provision of security functions. The actual data content (value) is not within the scope of
this standard, nor are the mechanisms that make use of these data elements. It is emphasised that the
security attributes cannot satisfy given security requirements without the implementation of the
appropriate security functions and mechanisms within the ICD.
READ — Always
— Never
— Protected
— With ICD holders’agreement
— With external authentication (for instance: card issuer, health care professional, ...)
— In relation to the originator only
WRITE — Protected
— With ICD holders’agreement
— With external authentication
— Never
UPDATE — Protected
— With external authentication
— With ICD holders’agreement
— In relation to the originator only
— Never
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ERASE — Protected
— With external authentication
— With ICD holders agreement
— In relation to the originator only
— Never
Following these principles a matrix of possibilities represents data access conditions:
PROTECTED
READ
WRITE
UPDATE
ERASE
Such rights of “access” are attributable to specific individuals with respect to discrete data items. These
rights will be defined by application developers and can be controlled by automated systems such as health
care professional cards. The rights may be defined at the application level thereby providing application
and potential country specificity.
The “SecurityServices” data object provides for the storage of data required to deliver these security
functions and mechanisms. These data can be “attached” to individual data elements thereby preserving
the original author’s security requirements when the data object is transferred between different forms of
ICD. This mechanism may therefore ensure that in the process of transferring data from active to passive
media and then back to active media, the original security requirements are re-generated. This ability also
allows exact replication of an ICD such as on regeneration after failure.
6.4 Link associations between objects
The following reference objects may be associated with other information objects defined. This relation is
a not an aggregation. The reference object is not a part of the information object but stays independent and
may be referenced by several objects.
The concept used within this European Prestandard is to reference (point at) the appropriate record person
as well as a healthcare provider and relevant accessory attributes.
These linkages add value to the data and may be used to provide context specificity.
6.4.1 The “RecordPersonPointer” data object
The data object “RecPersPointer” is used to reference one of the record persons stored in the
“RecordPersons” data object and shall be of integer type.
The ASN.1 representation of this data object is provided in Annex B, clause B.9.1.
6.4.2 The “ReferencePointer” and “ReferenceTag” data objects
A general reference pointer is defined in this European Prestandard as an ordered list of tags pointing to
the object or sub-object that is referenced.
The data object “RefPointer” shall consist of a sequence of “RefTag” (of integer type).
The “RefTag” is the APPLICATION SPECIFIC tag of the object as defined in this European Prestandard.
The following “RefTag”s specify the CONTEXT SPECIFIC tags in increasing depth.
The ASN.1 representation of this data object is provided in Annex B, clause B.9.2.
6.4.3 The “Linkages” data object
The “Linkages” object is used to create linkages between any objects. It shall be constructed as a sequence
of sub-objects “Link”.
The data object “Link” shall consist of a sequence of references to other objects in the form of a sequence of
“RefPointer” objects. This is pointed to by a “LinkagePointer” object.
The ASN.1 representation of this data object is provided in Annex B, clause B.9.3.
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The “RecPerVisitInstr” data object shall contain data that adds value to an address. This shall be a
separate object with a pointer to the address to which it relates.
The “RecPerVisitInstr” data object shall be constructed as a set of sub-objects “visitInstr” (an octet string
with a length of up to 80 characters), “visitPointer” (of “RecPersPointer” type as defined in clause 6.4.1),
and optional “AccessoryAttributes” (as defined in clause 6.3.5).
The ASN.1 representation of this data object is provided in Annex B, clause B.15.
7.6 The “Payment Provisions” data object
The “Payment provisions” data object shall cover a generic term that will include both insurance schemes
and national or other public healthcare payment systems.
There may be several instances of “Payment provisions” each of them with one payment body, which is the
term used to include insurance companies and other organisations which pay for healthcare delivery.
There may be a number of policies for each payment body. The policy conditions can cover several persons,
each with a set of conditions.
As an example the information contained in this object allows the storage of the information stated on the
official E 111 document held by any EU citizen travelling outside his/her member state (though within EU)
as enacted within Article 22 1(a) Council Regulation 1408/71.
The “PaymentProvisions” data object shall consist of a sequence of sub-objects “PaymentProvision”.
The “PaymentProvision” data object shall itself consist of a set of sub-objects:
— “PaymentBodyID”;
— optionally “PaymentBodyName” (an octet string with a length of up to 20 characters),
“PaymentBodyAddress” (a sequence of “Address”, “PostCode”, and “Country” as defined in
clauses [Link] to [Link], and “PaymentBodyTelecom” (of “Telecom” type, as defined in clause [Link]).
— “Policies”;
— and optionally “AccessoryAttributes” (as defined in clause 6.3.5).
The “PaymentBodyID” data object shall consist of a sequence of sub-objects “PaymentBodyCountry” (of
“Country” type as defined in clause above), and “PaymentBodyNumber” (an octet string with a length
comprised between 1 and 9 characters). “PaymentBodyCountry” represents the country of the payment
body number; the country of address may be different.
The “Policies” data object shall consist of a set of sub-objects “Policy”.
The “Policy” data object itself shall consist of a set of sub-objects “PolicyIdNo” (an octet string with a length
of up to 21 characters), “Member” (optional, an octet string with a length of up to 15 characters), and
“CoveredPersonConditions” (a set of sub-objects “PersonCondition”); the term “condition” is to be
understood in the sense of “conditions of cover” and not “medical condition”.
The “PersonCondition” data object shall consist of a sequence of sub-objects “RecPersPointer” (as defined
in clause 6.4.1), and “Condition”.
The “Condition” data object shall itself consist of a sequence of the following sub-objects:
— “ObligatoryStatus” (optional, boolean, “true” meaning “obligatory”);
— “CareCoverageCode” (optional, a set of “CoverageCode” of “CodedData” type as defined in
clause [Link]); CoverageCode will include (but is not limited to) surgical care, accident, occupational
disease, occupational accident, pregnancy, long term disease;
— “CareCoverageText” (optional, an octet string with a length of up to 20 characters);
— “CoverageAreas” (optional, a set of “CoveredCountries”, being themselves of “Country” type as defined
in clause [Link]);
— “PaymentLevel” (a sequence defined hereafter);
— “StartDate” (optional, of “Date” type as defined in clause [Link]);
— “EndDate” (optional, of “Date” type as defined in clause [Link]);
— “AccessoryAttributes” (optional, as defined in clause 6.3.5).
The “PaymentLevel” data object shall consist of a sequence of optional sub-objects:
— “LowerLimitCoverage” (of “Money” type), the value above which provisions are valid;
— “UpperLimitCoverage” (of “Money”), the value under which provisions are valid;
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8 Clinical data
This generic model for the storage of clinical data follows the same general structure as the storage of coded
administrative data as described above.
8.1 The “Clinical Coded Data” object
The “ClinicalCodedData” data object shall be constructed as a sequence of sub-objects “ClinDat”.
The “ClinDat” data object shall consist of a set of sub-objects “IDPatientCodedData” (of “RecPersPointer”
type), “ClinCodedData” (of “CodedData” type), “Parameter” (a choice of optional data objects to be defined
and described in clause 8.2), “ClinRefPointer” (of “LinkagePointer” type, a pointer to the “Link” element in
the “Linkages” reference table), and optionally “AccessoryAttributes” (as defined in clause 6.3.5).
The ASN.1 representation of this data object is provided in Annex B, clause B.19.
8.2 The “Parameter” data objects
The “Parameter” data objects are designed to be attached to a “ClinicalCodedData” data object, and by their
content they add value to that coded data. The “Parameter” data objects are distinct and their content vary
dependant upon their function: they define a structure and a set of rules related to this content.
8.2.1 The “Medication Note” parameter object
A “Medication Note” parameter object shall consist of a set of coded data consisting of:
“GenericMedCode”, coded data that shall represent the GENERIC name of the medicine as distinct
from either its proprietary or chemical name (e.g. ATC code);
“ProprietaryMedCode”, coded data that shall represent the proprietary name of the medicine;
“DosageInstructionsCode”, coded data that shall represent the dosage instructions;
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“PatientAdviceCode”, coded data that shall represent general advice regarding the medicine to be
conveyed to the patient.
NOTE The “ClinCodeData” object itself can also specify the literal proprietary name.
The ASN.1 representation of this data object is provided in Annex B, clause B.20.1.
8.2.2 The “Medication Prescription” parameter object
A “Medication Prescription” parameter object shall consist of a set of coded data consisting of:
“GenericMedCode”, coded data that shall represent the GENERIC name of the medicine as distinct
from either its proprietary or chemical name (e.g. ATC code);
“ProprietaryMedCode”, coded data that shall represent the proprietary name of the medicine;
“Strength”, a sequence of “NoStrengthUnits” of Real type, and “StrengthUnits” of coded data, that shall
represent the number of units and the nature of the units used to measure the strength of the medicine;
“Form”, coded data that shall represent the form of a medicine;
“DosageInstructionsCode”, coded data that shall represent the dosage instructions;
“PatientAdviceCode”, coded data that shall represent general advice regarding the medicine to be
conveyed to the patient;
“Iterations”, a numeric string that shall have the default value of 1 and shall represent the number of
times the quantity may be dispensed;
“QuantityToDispense”, a set of “DaysSupply” (of numeric string type), “NoDispenseUnits” (of real type),
and “DispenseUnits”, a choice of several boolean type objects (“TabletCaps” including suppositories,
vagitories and other forms of special “tablets” that may be sold as an arbitrary number of individual
entities, “Packages”, “Grams”, “Milligrams”, “Litres”, “Millilitres”, “IntlUnits”, and “Special”);
“ReimbursementInfo”, coded data that shall represent information about the level of reimbursement of
the considered medicine.
NOTE The “ClinCodeData” object itself can specify the specific proprietary name and also form, strength and package amount. In
this case the specially tagged objects for this information may be omitted.
The ASN.1 representation of this data object is provided in Annex B, clause B.20.2.
8.2.3 The “Medication Administered” parameter object
A “Medication Administered” parameter object shall consist of a set of coded data consisting of:
“GenericMedCode”, a code that represents the GENERIC name of the medicine as distinct from either
its proprietary or chemical names (e.g. ATC code);
“ProprietaryMedCode”, coded data that shall represent the proprietary name of the medicine;
“Strength”, a sequence of “NoStrengthUnits” of Real type, and “StrengthUnits” of coded data, that shall
represent the number of units and the nature of the units used to measure the strength of the medicine;
“Form”, coded data that shall represent the form of a medicine;
“DosageInstructionsCode”, coded data that shall represent the dosage instructions;
“PatientAdviceCode”, coded data that shall represent general advice regarding the medicine to be
conveyed to the patient;
“QuantityAdministered”, a set of “NoDispenseUnits” (of real type), and “DispenseUnits”, a choice of
several boolean type objects (“TabletCaps” including suppositories, vagitories and other forms of special
“tablets” that may be sold as an arbitrary number of individual entities, “Packages”, “Grams”,
“Milligrams”, “Litres”, “Millilitres”, “IntlUnits”, and “Special”).
“Batchidentifier (of Octectstring type), optional, to identify the production batch to which the
medication belongs to.
NOTE The “ClinCodeData” object itself can specify the specific proprietary name and also form, strength and package amount. In
this case the specially tagged objects for this information may be omitted.
The ASN.1 representation of this data object is provided in Annex B, clause B.20.3.
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The ASN.1 representation of this data object is provided in Annex B, clause B.20.6.
8.2.7 The “Digital Binary Data” parameter object
A “BinaryParam” parameter object shall consist of an octet string that can be used to represent any
additional type of digital data.
The ASN.1 representation of this data object is provided in Annex B, clause B.20.7.
8.2.8 The “Request” parameter object
A “Request” parameter object shall consist of a set of preferred date and planned date.
The ASN.1 representation of this data object is provided in Annex B, clause B.20.8.
8.2.9 The “Diagnosis” parameter object
A “Diagnosis” parameter object shall consist of a set of five booleans denoting the status of the diagnostic
label, the true value stating the designation of the diagnosis with respect to:
— unconfirmed or suspected;
— confirmed by tests;
— given on admission of patient to hospital or clinic;
— given at discharge of patient from hospital or clinic;
— and principal diagnosis.
The ASN.1 representation of this data object is provided in Annex B, clause B.20.9.
8.2.10 The “Procedures” parameter object
A “Procedures” parameter object shall consist of a set of coded data. The structure of the “CodedData” type
allows for this “Procedures” parameter object to designate the procedures either by a registered code,
e.g. OPCS-4 (“ProcedureCode”) or by a free text label (“GenericProcedureCode”).
The ASN.1 representation of this data object is provided in Annex B, clause B.20.10.
8.3 The limited emergency data set
An object “LimEmergencyData” shall consist of a set of data consisting of “EmergencyDataBitMap”, a
sequence of booleans, within which the status “true” shall indicate the presence of the condition in the
record person, or in the case of a medication that the record person may be taking this medication, plus the
optional element “AccessoryAttributes”. This object is intended to convey the majority of the fixed clinical
data set defined within the European emergency health record.
The conditions specified are the following:
— asthma;
— heart disease;
— epilepsy fits;
— neurological disorder;
— haemophilia;
— clotting disorder;
— diabetes;
— glaucoma;
— dialysis treatment;
— transplant;
— missing organ;
— pacemaker in situ;
— antipsychotic medication;
— anticonvulsants;
— antiarrythmics;
— blood pressure drugs;
— anticoagulants;
— antidiabetic agents;
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— antihistamines.
The ASN.1 representation of this data object is provided in Annex B, clause B.21.
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Annex A (informative)
General points about ASN.1 data objects representation
A representation of the data objects belonging to this European Prestandard is proposed hereafter in
informative annex using Abstract Syntax Notation One (ASN.1), of which normative references are:
ISO 8824:1990, Information technology — Open Systems Interconnection — Specification of Abstract
Syntax Notation One (ASN.1).
ISO 8825:1990, Information technology — Open Systems Interconnection — Specification of Basic
Encoding Rules for Abstract Syntax Notation One (ASN.1).
A.1 ASN.1 definitions
A.1.1
asn.1 encoding rules
rules specifying the representation during transfer of the value of any ASN.1 type. [ISO 8824:1990]
A.1.2
bitstring type
a simple type whose distinguished values are an ordered sequence of zero, one or more bits [ISO 8824:1990]
A.1.4
boolean type
a simple type with two distinguished values. Possibilities are true or false [ISO 8824:1990]
A.1.5
co-ordinated universal time (UTC)
the time scale maintained by the Bureau international de l’heure (International Time Bureau) that forms
the basis of a co-ordinated dissemination of standard frequencies and time signals [ISO 8824:1990]
A.1.6
simple type
a type defined by directly specifying the set of its values [ISO 8824:1990]
A.1.7
structured type
a type defined by reference to one or more other types [ISO 8824:1990]
A.1.8
tag
a type denotation which is associated with every ASN.1 type [ISO 8824:1990]
A.1.9
tagging
replacing the existing (possibly default) tag of a type by a specified tag [ISO 8824:1990]
A.1.10
type
a named set of values [ISO 8824:1990]
A.1.11
type or value reference name
a name associated uniquely with a type or value within some context [ISO 8824:1990]
A.1.12
integer type
a simple type with distinguished values which are the positive and negative whole numbers including zero.
[ISO 8824:1990]
A.1.13
real type
a simple type whose distinguished values are members of the set of real numbers [ISO 8824]
A.1.14
octet string type
a simple type whose distinguished values are an ordered sequence of zero, one or more octets, each octet
being an ordered sequence of eight bits [ISO 8824:1990]
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A.1.15
null type
a simple type consisting of a single value called null [ISO 8824:1990]
A.1.16
set type
a structured type, defined by referencing a fixed, unordered, list of distinct types (some of which may be
declared to be optional); each value in the new type is an unordered list of values, one from each of the
component types [ISO 8824:1990]
A.1.17
set of type
a structured type, defined by referencing a single existing type; each value in the new type is an unordered
list of zero, one or more values in the existing type [ISO 8824:1990]
A.1.18
sequence-of-type
a structured type defined by referencing a single existing type, each value of the new type being in an
ordered list of zero, one or more values of the existing type [ISO 8824:1990]
A.1.19
sequence type
a structured type, defined by referencing a fixed, ordered, list of types (some of which may be declared to
be optional); each value of the new type is an ordered list of values, one from each component type
[ISO 8824:1990]
A.1.20
value
a distinguished member of a set of values [ISO 8824:1990]
A.2 ASN.1 syntax
The ASN.1 syntax is used to build complex data objects that all are derived from a set of elementary types
that are defined in ASN.1. The elementary types used in this standard are:
Birthdate 4 Date
Meaning a birthdate has the format of the general Date-type but in addition a specific connotation.
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Tag is a label that is used to identify the object. It may be of several forms.
The Length component defines the length of the Value field. Generally ASN.1 objects have variable length
allowing for flexibility and application specific priorities. In this standard, however, a maximum length
allowed is defined for certain objects, to facilitate the interchange with application systems that could be
designed to be able to handle any ICD issued according to this standard.
Value is a field that may be of elementary type, e.g. an OCTET STRING. However, in case of constructed
aggregate objects frequently used in this standard, the value field may also contain an object. In this way
objects may be nested in many layers.
Constructed Object
0 1 2 3 4 5
Application Context level 1 Context level 2 Context level 3 Context level 4 Context level 5 etc.
A.5 Examples of using the Basic Encoding Rules for use with ASN.1 for objects in this standard
Example: Firstnames value assignment:
{Firstname “ANNA”, preferred firstname “GERTRUD”, Firstname “MARIA”}
Encoded format
Firstnames tag class context specific e.g. 129
Preferred firstname tag class context specific e.g. 130
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129 4 “ANNA”
130 7 “GERTRUD”
129 5 “MARIA”
Address Example
{Postaddr “Wyntroyd*Howbrook*[Link]”,
ExtHealthCareAddr“Wyntroyd Farm*Hollinberry Lane*Howbrook*High Green*Nr
Sheffield*[Link]”
}
Encoded Format
Address tag class application specific e.g. xxx
Postaddr tag class application specific e.g. yyy
ExtHealthCareAddr tag class application specific e.g. zzz
Annex B (normative)
ASN.1 representation of data objects in this European Prestandard
Annex B takes precedence over any other clause of this European prestandard which may state or imply
contradictory descriptions of data objects.
This normative annex defines using ASN.1 notation the contents of the data objects and their structure.
The storage and transmission methodology to be used is outside the scope of this European Prestandard.
B.1 Basic Data Objects for Referencing
B.1.1 Person Name related data objects
The plain text definition of these objects is provided in normative clause 6.2.1.
Fullname 4 SEQUENCE
{ Title OPTIONAL,
Surnameprefix OPTIONAL,
Surnames,
Surnamesufix OPTIONAL
Forenames
}
{
Title [0] 4 OCTET STRING OPTIONAL (SIZE(1..7)),
Surnameprefix [1] 4 OCTET STRING OPTIONAL (SIZE(2..15)),
Surnames [2] 4 SEQUENCE OF SIZE(1..2),
CHOICE {Surname,PreferredSurname}
-- maximum two surnames
{
Surname [0] 4 Nameelement,
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Telecom 4 SET
{
TelnoRecpersonHome [0] Telno OPTIONAL,
TelnoRecpersonwork [1] Telno OPTIONAL,
TelnoRecpersonother [2] Telno OPTIONAL,
FaxnoRecpersonhome [3] Telno OPTIONAL,
FaxnoRecpersonwork [4] Telno OPTIONAL,
X.400address [5] OCTET STRING OPTIONAL,
OtherNetworkAddress [6] OCTET STRING OPTIONAL
}
Money 4 SEQUENCE
{
Amount [0] INTEGER,
Currency [1] OCTET STRING (SIZE(3)) OPTIONAL
-- ISO 4217
}
B.2 Basic Data Objects
B.2.1 The “Record Persons” data object
The plain text definition of this object is provided in normative clause 6.3.1.
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RecordPerson 4 SET
{
MajorRecordldentifier,
AlternativeRecordIdentifiers OPTIONAL,
RecordIdVerification
}
B.2.2 The “Major Record Identifier” data object
The plain text definition of this object is provided in normative clause [Link].
EvolRecordIdentifier 4 CHOICE
{
evolution1 [0] OCTET STRING (SIZE (1..21)),
evolution2 [1] OCTET STRING (SIZE (1..21)),
evolution3 [2] OCTET STRING (SIZE (1..21))
}
-- The Evolution1 type defines a RecordIdentifier that
-- has free format
-- The Evolution2 type defines a RecordIdentifier that
-- has only alphanumeric characters and the
-- separator “/”
-- The Evolution3 type defines a RecordIdentifier that
-- is all numeric with no separators
B.2.3 The “Alternative Record Identifiers” data object
The plain text definition of this object is provided in normative clause [Link].
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HealthCareSite 4 SET
{ hcsCountry [0] Country,
hcsId [1] Numeric String (SIZE(1..21)) OPTIONAL,
hcsName [2] OCTET STRING (SIZE(15)),
hcsAddr [3] Address
hcsType [4] CodedData OPTIONAL,
-- This is a code that determines the type of
-- establishment i.e. Doctors Surgery, Clinic,
-- Hospital, Laboratory etc.
hcsTelecom [5] Telecom
}
B.5 The “Healthcare Persons” data object
The plain text definition of this object is provided in normative clause [Link].
HealthCarePersons 4 [APPLICATION 11] SEQUENCE OF HealthCarePerson
HealthCarePerson 4 SET
{
HCPCountry [0] Country
HCPIdNo [1] NumericString (SIZE(1..21)),
HCPName [2] Fullname,
HCPRelationCode [3] CodedData OPTIONAL,
-- This is a code that would indicate things like
-- Primary responsible General Practitioner
-- Specialist, consultant, etc.
HCPClass [4] Sequence of BOOLEAN
{
Doctor [0] BOOLEAN
Dentist [1] BOOLEAN
Pharmacist [2] BOOLEAN
Midwife [3] BOOLEAN
Nurse [4] BOOLEAN
Admin. [5] BOOLEAN
Professions allied to medicine [6] BOOLEAN
Professions allied to dentistry [7] BOOLEAN
Professions allied to pharmacy [8] BOOLEAN
Professions allied to nursing [9] BOOLEAN
},
hcpProfession [5] SEQUENCE OF HcpProfCode OPTIONAL,
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SiteMix 4 SET
{
HCSRef 4 [0]RefPointer,
-- Pointer to HealthCareSite object
HCPRef 4 [1]RefPointer,
-- Pointer to HealthCarePerson object
}
B.7 Coded data and coding schemes
B.7.1 The “Coding Schemes Used” data object
The plain text definition of this object is provided in normative clause [Link].
CodingSchemesUsed 4 [APPLICATION 13] SEQUENCE OF CodingScheme
CodingScheme 4 SEQUENCE
{
codeIdentifier [0] OCTET STRING(SIZE 6)),
codeLength [1] INTEGER,
Comment [2] OCTET STRING(SIZE(1..20)) OPTIONAL }
}
B.7.2 The “Coded Data” data object
The plain text definition of this object is provided in normative clause [Link].
CodedData 4 SET
{
codingSchemeRef [0] RefPointer.
codeDataValue [1] OCTET STRING,
codeDataFreeText [2] OCTET STRING OPTIONAL
}
-- codingSchemeRef is a Ref Pointer pointing at a
-- value that identifies a particular coding scheme
-- within the object coding schemes used.
-- If CodingSchemeRef = 0 then the coding scheme
-- is implicit in this standard. The length of the
-- CodeDataValue is one OCTET and the following
-- CodeDataValues are defined: “A” = Administrative
-- free text entry, and “C” = Clinical free text entry
B.8 The “Accessory Attributes” data object
The plain text definition of this object together with its functions are provided in normative clause 6.3.5.
AccessoryAttributes 4 SET
{
date1 [0] UTC TIME (SIZE (6..12)) OPTIONAL,
date2 [1] UTC TIME (SIZE (6..12)) OPTIONAL
place/Person 1 [2] RefPointer OPTIONAL,
place/Person2 [3] RefPointer OPTIONAL,
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SecurityLevels 4 SEQUENCE
{
ReadSecAttribute [0] SecAttData OPTIONAL
WriteSecAttribute [1] SecAttData OPTIONAL
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RefTag 4 INTEGER
-- This object can hold the ASN.1-tag of another object
B.9.3 The “Linkages” data object
The plain text definition of this object is provided in normative clause 6.4.3.
Linkages 4 [APPLICATION 22] SEQUENCE OF Link
-- This is a sequence of references to other objects
LinkagePointer 4 INTEGER
B.10 Data from ICDs held by healthcare persons
The plain text definition of this object is provided in normative clause 6.5.
HcpData 4 [APPLICATION 25] IMPLICIT SEQUENCE
{
HealthCarePerson [0],
HealthCareSite [1],
[2] AccessoryAttributes OPTIONAL
}
B.11 Basic ID & Administration Data
The plain text definition of these objects is provided in normative clause 7.1.
VariableIdData 4 [APPLICATION 14] SEQUENCE OF RecPersVariableID
RecPersVariableID 4 SET
{
Address [0]Address OPTIONAL,
PreviousAddresses [1] SEQUENCE OF Address OPTIONAL,
Telecom [2] Telecom OPTIONAL,
Preferred Languages [3] CodedData OPTIONAL,
MaidenName [4] OPTIONAL,
PreviousSurname [5]OPTIONAL,
OtherNames [6]OPTIONAL,
[7]AccessoryAttributesOPTIONAL
}
B.11.1 The “Address” data object
The plain text definition of this object is provided in normative clause 7.1.1.
Address 4 SEQUENCE
{
PostAddr [0] OCTET STRING (SIZE (1..35)),
ExtHcareAddr [1] OCTET STRING (size(2..175)) OPTIONAL
}
B.11.2 The “Record Person Telecom” data object
The plain text definition of this object is provided in normative clause 7.1.2.
RecordPersonTelecom 4 Telecom
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PaymentProvision 4 SET
{
PaymentBodyID [0],
PaymentBodyName OPTIONAL [1],
PaymentBodyAddress OPTIONAL [2],
PaymentBodyTelecom OPTIONAL [3],
Policies [4],
AccessoryAttributes OPTIONAL [5]
}
Policy 4 SET
{
PolicyIdNo [0] OCTET STRING(SIZE(0..21)),
MemberNo [1] OCTET STRING(SIZE(0..15)) OPTIONAL,
CoveredPersonConditions [2] SET OF PersonCondition
}
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PersonCondition 4 SEQUENCE
{
RecPersPointer [0] RecPersPointer,
Conditions [1] SET OF Condition
}
Condition 4 SEQUENCE
{
ObligatoryStatus OPTIONAL [0],
CareCoverageCode OPTIONAL [1],
CareCoverageText OPTIONAL [2],
CoverageAreas OPTIONAL [3],
PaymentLevel [4],
StartDate OPTIONAL [5],
EndDate OPTIONAL [6],
AccessoryAttributes OPTIONAL [7]
}
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CoverageCode 4 CodedData,
-- CoverageCode shall include (but is not limited
-- to) Surgical Care, Accident, Occupational
-- Disease, Occupational accident, Pregnancy,
-- Long term disease
B.17 The “Patient Payments” data object
The plain text definition of this object is provided in normative clause 7.7.
PatientPayments 4[APPLICATION 20] SET
{
IdPatientPayment [0] RecPersPointer,
PatientAccPayment [1] Money,
PatientCarePayments [2] SEQUENCE OF PatientCarePayment,
[3] AccessoryAttributes OPTIONAL
}
PatientCarePayment 4 SET
{
ProcedureRef [0] RefPointer,
-- A pointer to the procedure that was
-- paid for
ProcedureAmount [1] Money
}
B.18 The “Other Coded Administrative Data” object
The plain text definition of this object is provided in normative clause 7.8.
OtherCodedAdminData 4 [APPLICATION 21] SEQUENCE OF AdmDat
AdmDat 4 SET
{
IDPatientCodedData [0] RecPersPointer,
AdmCodedData [1] Coded Data,
AdminMoney [2] Money,
AdmRefPointer [3] LinkagePointer
-- This is a pointer to the Link element in the
-- Linkages reference table,
[4] AccessoryAttributes OPTIONAL
}
B.19 The “Clinical Coded Data” object
The plain text definition of this object is provided in normative clause 8.1.
ClinicalCodedData 4 [APPLICATION 23] SEQUENCE OF ClinDat
ClinDat 4 SET
{
IDPatientCodedData [0] RecPersPointer,
ClinCodedData [1] CodedData,
Parameter [2] CHOICE OPTIONAL,
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{
MedicationNoteParam [0],
MedicationPrescriptionParam [1],
MedicationAdministeredParam [2],
MedicationDispenseParam [3],
Drug SensitivityParam [4],
LabTestResultsParam [5],
BinaryParam [6],
RequestedParam [7],
DiagnosisParam [8],
ProceedureParam [9]
}
-- The structure of the parameter object will be
-- dependent upon the ClinCodeData and the
-- modifier
ClinRefPointer [3] LinkagePointer,
-- This is a pointer to the Link element in the
-- Linkages reference table,
[4] AccessoryAttributes
}
B.20 The “Parameter” data objects
The plain text definition of these data object are provided in normative clause 8.2.
B.20.1 The “Medication Note” parameter object
The plain text definition of this object is provided in normative clause 8.2.1.
MedicationNoteParameter 4[0] SET
{
GenericMedCode [0]Coded Data,
-- E.g. ATC-code
ProprietaryMedCode [1] CodedData,
DosagelnstructionsCode [2]CodedData,
PatientAdviceCode [3]CodedData
}
B.20.2 The “Medication Prescription” parameter object
The plain text definition of this object is provided in normative clause 8.2.2.
MedicationPrescriptionParam 4 [1] SET
{
GenericMedCode [0] CodedData,
. -- E.g. ATC-code
ProprietaryMedCode [1] CodedData,
Strength [2] SEQUENCE,
{ NoStrengthUnits [0] Real,
StrengthUnits [1] CodedData
}
Form [3] CodedData,
DosageInstructionsCode [4] CodedData,
PatientAdviceCode [5] CodedData,
Iterations [6] NUMERIC STRING DEFAULT 1,
-- The number of times the quantity may be
-- dispensed
QuantityToDispense [7] SET,
{
DaysSupply [0] NUMERIC STRING,
NoDispenseUnits [1] REAL,
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{
ProprietaryMedCode [0] CodedData,
GenericMedCode [1] Coded Data
-- E.g. ATC-code
}
Strength [1] SEQUENCE
{ NoStrengthUnits [0] Real,
StrengthUnitsCode [1] CodedData
}
Form [2] CodedData
DosageInstructionsCode [3] CodedData,
PatientAdviceCode [4] CodedData,
IterationNo [5] NUMERIC STRING DEFAULT 1,
-- The sequence number of the quantity being dispensed
QuantityDispensed [6] SET,
{
DaysSupply [0] NUMERIC STRING,
NoDispenseUnits [1] REAL,
DispenseUnits [2] CHOICE OF
{
TabletCaps [0] BOOLEAN,
-- This includes suppositories, vagitories and other
forms of special “tablets” that may be sold as an
arbitrary no of individual entities
Packages [1] BOOLEAN,
Grams [2] BOOLEAN,
Milligrams [3] BOOLEAN,
Litres [4] BOOLEAN,
Millilitres [5] BOOLEAN,
IntlUnits [6] BOOLEAN,
Special [7] BOOLEAN
}
DispensedByID [7] HcpRefPointer
DispensedDate [8] Date,
DispensedPrice [9] Money OPTIONAL,
DispensedPaid [10] Money OPTIONAL
BatchIdentifier [11] OCTETSTRING OPTIONAL
DispensingIdentifier [12] OCTETSTRING OPTIONAL
-- Represents identifier allocated to the
dispensed item allocated by the
dispensing pharmacist
B.20.5 The “Drug Sensitivity” parameter object
The plain text definition of this object is provided in normative clause 8.2.5.
DrugSesitivityParam 4 [4] CodedData
B.20.6 The “Laboratory Test Results” parameter object
The plain text definition of this object is provided in normative clause 8.2.6.
LabTestResultsParam 4 [5] SET OF Results
Results 4 SET
{
TimeSample [0] UTC Time,
LabResult [1] LabValue,
NormalRange [2] BOOLEAN DEFAULT TRUE,
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LabValue 4 SET
{ Units [0] CodedData,
Value [1] REAL
}
B.20.7 The “Digital Binary Data” parameter object
The plain text definition of this object is provided in normative clause 8.2.7.
BinaryParam 4 [7] OCTET STRING
B.20.8 The “Request” parameter object
The plain text definition of this object is provided in normative clause 8.2.8.
RequestParam 4 [8] SET
{
PreferredDate [0] Date,
PlannedDate [1] Date
}
B.20.9 The “Diagnosis” parameter object
The plain text definition of this object is provided in normative clause 8.2.9.
DiagnosisParam 4 [9] SET OF BOOLEAN
{
UnconfirmedDiagnosis [0] Boolean,
-- True means unconfirmed or suspected
ConfirmedDiagnosis [1] Boolean,
-- True means diagnosis confirmed by tests
DiagnosisAtAdmision [2] Boolean,
— True means diagnosis given on admission to
-- hospital or clinic
DiagnosisAtDischarge [3] Boolean,
-- True means diagnosis given at discharge of
-- patient from clinic or hospital
PrincipalDiagnosis [4] Boolean
-- True means diagnosis is principal diagnosis
}
B.20.10 The “Procedure” parameter object
The plain text definition of this object is provided in normative clause 8.2.10.
ProcedureParam 4 [10] SET
{
ProcedureCode [0] CodedData,
GenericProcedureCode [1] CodedData
-- e.g. OPCS4
}
B.21 The Limited Emergency Data Set
The plain text definition of this object is provided in normative clause 8.3.
LimEmergencyData 4 [APPLICATION 24]SET
{
EmergencyDataBitMap 4 [0] SEQUENCE OF BOOLEANS
{
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Asthma [0],
HeartDisease [1],
EpilepsyFits [2],
NeurologicalDisorder [3],
Haemophilia [4],
ClottingDisorder [5],
Diabetes [6],
Glaucoma [7],
DialysisTreatment [8],
Transplant [9],
MissingOrgan [10],
PacemakerInSitu [11],
AntipsychoticMedication [12],
Anticonvulsants [13],
Antiarrythmics [14],
BloodPressureDrugs [15],
Anticoagulants [16],
AntidiabeticAgents [17],
Antihistamines [18]
}
[1] AccessoryAttributes OPTIONAL
}
B.22 Specific ICDs security services related data objects
B.22.1 Patient devices security related data
The plain text definition of this data object is provided in normative clause 9.1.
PatientDevSecurity 4 [4] SET
{
IcdHolderVer [0],
DevClassAuthenticateData [1],
PatEncryptionData [2],
PatsSignatureFunctData [3],
HcpAuthenticateData [4]
}
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HCPKeyID 4 OCTET
B.22.2 Healthcare persons devices security related data
The plain text definition of this data object is provided in normative clause 9.2.
HCPDevSecurity 4 [5] SET
{
IcdHolderVer [0],
IdAuthenticateData [1],
DevClassAuthenticateData [2],
PatientICDAccessData [3],
HcpEncryptionData [4],
HcpSignFuncData [5]
}
Certificate 4 SEQUENCE
{
Version [0] Version DEFAULT 1988,
SerialNumber [1] SerialNumber OPTIONAL,
CertAlgorithm [2] AlgorithmIdentifier OPTIONAL,
CertIssuer [3] CertificateAuthority OPTIONAL,
Validity [4] Validity OPTIONAL,
HcpIdNo [5] Name OPTIONAL,
HcpPublicKeyInfo [6] SubjectPublicKeyInfo OPTIONAL,
CertSign [7] CertSignature OPTIONAL
-- This object description of a certificate is derived
-- from ISO/IEC 9594-8
}
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SerialNumber 4 INTEGER
Validity 4 SEQUENCE
{
NotBefore [0]UTCTime,
NotAfter [1]UTCTime}
AlgorithmIdentifier 4 SEQUENCE
{
Algorithm [0] OBJECT IDENTIFIER,
Parameters [1] ANY DEFINED BY algorithm
OPTIONAL}
CertificateAuthority 4 Name
SubjectPublicKeyInfo 4 SEQUENCE
{
Algorithm [0] algorithmIdentifier,
SubjectPublicKey [1] BIT STRING}
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Annex C (informative)
The hierarchy of data objects
This annex shows the hierarchy of most data objects. The tags attached to the objects subsequently follows
the same hierachy.
C.1 Basic data objects for referencing
RecordPersons
MajorRecordPerson
Spouse
Child
Father
Mother
OtherPerson
RecordPerson
MajorRecordIdentifier
RecordIdentifier
MII
IssuerCountry
IssuerIdentifier
Checkdigit
RecordIDNumber
AlternativeRecordIdentifiers
SocialSecurityNo
AlternativeNumbers
RecordIdentifier
MII
IssuerCountry
IssuerIdentifier
Checkdigit
RecordIDNumber
RecordIdVerification
RecordpersonName
Fullname
Title
Surnameprefix
Surnames
Surname
Surnamesufix
Forenames
Forename
DateofBirth
Sex
PlaceofBirth
AccessoryAttributes
DeviceData
Devtype
DeviceClass
Device Standard
DevicSpec
DevApplications
DevApplicationClass
Identification
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Administrative
Clinical
Other
DevApplicationCodes
DevDirectory
DevIdentification
DeviceManufacturer
DeviceComponentManuf
DevicePersonaliser
DeviceIdNo
DeviceIssueDate
PatientDev Security
ICDHolderVer
VerificationMethod
VerificationData
DevClassAuthenticateData
AuthenticationMethod
DevAuthenticationKey
PatEncryptionData
PatEncAlgorithmID
PatEncKeyID
PatSignatureFunctData
PatSignAlgorithmID
PatSignKeyID
HCPAuthenticateData
HCPAuthentMethod
HCPIntKeys
HCPNatKeys
HCPDevSecurity
ICDHolderVer
VerificationMethod
VerificationData
DevClassAuthenticateData
AuthenticationMethod
DevAuthenticationKey
PatientICDAccessData
HCPIntAccessIDs
IntlAccessID
HCPNatAccessIDs
NatAccessID
IDAuthenticateData
IDAuthenticateMethod
IDAuthenticateKey
AuthenticateCert
Certificate
Version
SerialNumber
CertAlgorithm
CertIssuer
Validity
CertStartDate
CertEndDate
HCPIdNo
HCPPublicKeyInfo
CertSign
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HCPSignFuncData
SignMethod
SignKey
SignatureCertificate
Certificate
HealthCareSites
HealthcareSite
HcsCountry
HcsIdNo
HcsName
HcsAddr
PostalAddress
ExtHcAddress
HcsPostCode
HcsAddrCountry
HcsTelecom
HealthCarePersons
HealthCarePerson
HcpCountry
HcpIdNo
HcpName
Fullname
HcpRelationCode
HcpClass
HcpProfession
HcpEmploymentNo
HcpEmploymentData
SiteMixTable
SiteMix
HcsRef
HCPRef
CodingSchemes Used
Coding Scheme
CodeIdentifier
CodeLength
Comment
CodedData
CodingSchemeRefno
CodeDataValue
CodeDataFreeText
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Address
PostalAddress
ExtHealthCareAddress
HcpData
HealthcarePerson
HealthcareSite
AccessoryAttributes
AccessoryAttributes
Date1
Date2
Place/Person1
Place/Person2
Place/Person3
PersonCode
PersonText
SecurityLevels
ReadSecAttribute
WriteSecAttribute
UpdateSecAttribute
EraseSecAttribute
CompressionMethod
ObjectSecurityAttributes
SecurityServices
SignatureAlgorithmId
SignatureKeyId
DigitalSignature
EncryptionAlgorithmId
EncryptionKeyId
SecurityLevels
ReadSecAttribute
WriteSecAttribute
UpdateSecAttribute
EraseSecAttribute
CompressMethodData
SecAttData
Always
Never
ProtExtAg
ProtHoldAg
ProtAuthAg
VariableIdData
RecPersVariableId
Address
Telecom
PreferredLanguages
Language
MaidenName
MaidenSurname
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AccessoryAttributes
Previous Surname
Surnames
AccessoryAttributes
OtherNames
Fullname
AccessoryAttributes
RecPersPostCode
Post Code
RecPersPointer
RecPersCountry
Country
RecPersPointer
ContactPersons
ContactPerson
Name
Fullname
ContactTelNo
Telecom
Comment
RecPersPointer
AccessoryAttributes
RecPersVisitInstr
VisitInstr
RecPersPointer
AccessoryAttributes
PaymentProvisions
Payment Provision
PaymentBodyID
PaymentBodyCountry
PaymentBodyNumber
PaymentBodyName
PaymentBodyAddress
Address
PostCode
Country
PaymentBodyTelecom
Policies
PolicyIDno
MemberNo
CoveredPersonConditions
PersonCondition
RecordPersPointer
Conditions
Condition
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ObligatoryStatus
CareCoverageCode
CareCoverageText
CoverageAreas
CoveredCountries
Country
PaymentLevel
LowerLimitCoverage
Money
Amount
Currency
UpperLimitCoverage
Money
Amount
Currency
BenefitsRate
SetPrice
SetPriceValue
Amount
Currency
ThirdParty
EmploymentStatus
Employed
SelfEmployed
EmployedPensionable
SelfEmployedPensionable
AuthorisationReq
StartDate
EndDate
AccessoryAttributes
PatientPayments
IdPatientPayment
RecPersPointer
PatientAccPayment
Money
PatientCarePayments
PatientCarePayment
ProcedureRef
ProcedureAmount
AccessoryAttributes
OtherCodedAdminData
AdmData
AdmCodedData
AdminMoney
AdmRefPointer
AccessoryAttributes
Linkages
Link
RefPointer
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ClinicalCodedData
ClinDat
IDPatientCodedData
ClinCodedData
Parameter
MedicationNoteParam
GenereicMedCode
ProprietaryMedCode
DosageInstructionsCode
PatientAdviceCode
MedicationPrescriptionParam
GenericMedCode
ProprietaryMedCode
Strength
NoStrengthUnits
StrengthUnit
Form
Dosage InstructionsCode
PatientAdviceCode
Iterations
QuantityToDispense
DaysSupply
NoDispenseUnits
DispenseUnits
Tablets
Caps
Packages
Grams
Milligrams
Litres
Millilitres
InternationalUnits
Special
ReimbursementInfo
MedicationAdministeredParam
GenericMedCode
ProprietaryMedCode
Strength
NoStrengthUnits
StrengthUnitCode
Form
DosageInstructionsCode
PatientAdviceCode
QuantityAdministered
NoDispenseUnits
DispenseUnits
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MedicationDispenseParam
MedicationDispensedActual
GenericMedCode
ProprietaryMedCode
Strength
NoStrengthUnits
StrengthUnitCode
Form
DosageInstructionsCode
PatientAdviceCode
IterationNo
QuantityDispense
DaysSupply
NoDispenseUnits
DispenseUnits
DispensedById
DispensedDate
DispensedPrice
DispensedPaid
DrugSensitivityParam
CodedData
LabTestResultsParam
Results
TimeSample
Labresult
LabValue
Units
Value
NormalRange
RefLowerLimit
LabValue
RefUpperLimit
LabValue
BinaryParam
DiagnosisParam
UnconfirmedDiagnosis
ConfirmedDiagnosis
DiagnosisAtAdmission
DiagnosisAtDischarge
PrincipleDiagnosis
RequestParam
PreferredDate
PlannedDate
ProcedureParam
ProcedureCode
CodedData
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GenericProcedureCode
CodedData
ClinRefPointer
AccessoryAttributes
LimitedEmergencyData
EmergencyDataBitMap
BitMap
AccessoryAttributes
C.4 Specific ICDs security services related data objects
PatientDevSecurity
ICDHolderVer
VerificationMethod
VerificationData
DevClassAuthenticateData
AuthenticationMethod
DevAuthenticationKey
PatEncryptionData
PatEncAlgorithmID
PatEncKeyID
PatSignatureFunctData
PatSignAlgorithmID
PatSignKeyID
HCPAuthenticateData
HcpAuthentMethod
HcpIntlKeys
HcpNatKeys
HCPDevSecurity
ICDHolderVer
VerificationMethod
VerificationData
IdAuthenticateData
IdAuthenticMethod
IdAuthenticateKey
AuthenticateCert
Certificate
Version
SerialNumber
CertAlgorithm
CertIssuer
Validity
HcpIdNo
HcpPublicKeyInfo
CertSign
DevClassAuthenticate Data
AuthenticationMethod
DevAuthenticationKey
PatientICDAccessData
HcpIntlAccessIDs
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HcpNatAccessIDs
AccessKeys
HcpEncryptionData
HcpEncAlgorithmID
HcpEncKeyID
HcpSignFuncData
SignMethod
SignKey
SignatureCertificate
Annex D (normative)
Application specific data object tags and their values
This standard defines certain referencable tags each of which has a specific associated value shown below.
Any application may define its own private tags for additional data, but the range 32-63 inclusive shall be
reserved for constructed objects.
RecordPersons 45
DeviceData 46
HealthCareSites 47
HealthCarePersons 48
SiteMixTable 49
CodingSchemesUsed 50
VariableIdData 51
RecPersPostCode 52
RecPersCountry 53
ContactPersons 54
RecPersVisitlnstr 55
PaymentProvisions 56
PatientPayments 57
OtherCodedAdminData 58
Linkages 59
ClinicaICodedData 60
LimEmergencyData 61
HcpData 62
Annex E (informative)
Devices that may function as Intermittently Connected Devices
Passive memory media
Magnetic
Standard Magstripe Cards
Nonstandard Magnetic techniques, low and high density
Optical
Printed barcode
Laser recorded reflex alteration
Transparent microsphere technology
Integrated Circuit Chip (Synchronous non-microprocessor type)
EPROM (non erasable)
EEPROM (erasable)
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Discs
Flexible diskettes
Hard diskettes
Smart diskettes
Removable winchesters
Removable optical disks
Removable magneto-optical
Tapes
Magnetic tape cassettes
Other digital tape cassettes
Optical tape cassettes
Magnetic tape on wheels
Optical tape on wheels
Portable computers
Handhold computers of all types
Notebook computers
Other portable computers
Other devices
Portable ECG and blood pressure monitors and similar devices
Portable imagers
Portable scanners
Etc.
Annex F (informative)
Data Dictionary
This Data Dictionary lists the data objects, of various data types, in a format different from the normative
ASN.1 objects previously described.
The data objects taken from within this data dictionary are combined in different combinations to produce
data objects that are identifiable by their tags and have defined structures intended for specific uses
e.g. providing for the function of identifying an individual or passing an electronic prescription. Some data
elements can be combined in many different structures whilst retaining the same format and content and
may be repeated with different tags in order to perform different functions i.e. identify different
individuals.
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It should be noted that the Data Dictionary description does not completely define the richness and
complexity of the ASN.1 syntax descriptions.
This table should not be regarded as being identical to the attribute layer specification as
described within EDIFACT syntax, in that it contains data types inadmissible within EDIFACT.
The reader is referred to the normative ASN.1 definitions in Annex A for full textual clarity.
F.1 Data types
The following data types are used in the data dictionary table:
a) string (S): a string of characters from the ISO 8859-1:1987 character sets; (This corresponds to the use
of the ASN.1 OCTET STRING in the normative part of the standard);
b) time of calendar date (D): string limited to the representation of the year, month, day, hour, minutes,
seconds. This time of calendar date is represented as UTC time (ISO 8824:1990);
c) boolean (B): a simple type with two distinguished values. Possibilities are true or false
(ISO 8824:1990);
d) integer (I): a simple type with distinguished values which are the positive and negative whole
numbers including zero (ISO 8824:1990);
e) real (R): a simple type whose distinguished values are members of the set of real numbers
(ISO 8824:1990);
f) coded data (C): this data type consists of 3 components:
1) a coding scheme indicator pointing to a device specific table of coding schemes used. This table will
contain a reference to the HCD (Healthcare Coding Scheme Designator) or ICD (International Coding
Scheme Designator): data type integer, mandatory component,
2) code value: data type string, mandatory component,
3) free text: data type string, optional component;
NOTE When there is an explicit definition of a particular coding scheme to be used within the normative standard, data values
may actually be codes but of data type string and with no reference to the coding scheme used, which is implicitly defined by the
standard.
g) set of coded values (SC): value which may be represented by a repetition of coded values;
h) bit string (BS): Data type represented as a bit string (ISO 8824:1990);
i) attribute group (AG): compound data type used to group together a set of logically coherent attributes
and/or attribute groups;
j) common attribute group (CAG): compound data type used to group together a set of logically coherent
attributes, described separately;
k) [Link].(RT) a reference tag of the integer type being a number. A pointer to a look up table containing
the reference tags of other objects.
l) Reference pointer (SRT) a sequence of [Link].
F.2 Status of the attributes within the objects
The abbreviations used in the table indicate the status of an attribute or attribute group when the related
object is present in a message. Instances are:
— M: mandatory;
— O: optional;
— NA: not applicable.
The status of an entry in the table for an attribute or attribute group for a given object is only applicable
when the higher level component (the object for attribute groups and attributes, the attribute group for
attributes and attribute groups belonging to such a group) is present in any stored data object or data
exchange.
Table F.1 does not include the “data objects” used for commands and responses relating to initiation and
closure of sessions with ICDs, nor read and write requests and responses.
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DATE 2 12 D O
PLACE/PERSON 1 RT O
PLACE/PERSON 2 RT O
PLACE/PERSON 3 RT O
PERSON 3 TEXT 30 S O
SECURITY LEVELS 1 CAG O
READSECATTRIBUTE B O
WRITE SEC ATTRIBUTE B O
UPDATE SEC ATTRIBUTE B O
ERASE SEC ATTRIBUTE B O
COMPRESSION METHOD RT O
OBJECT SECURITY ATTRIBUTES CAG O
SIGNATURE ALGORITHM ID RT O
SIGNATURE KEY ID RT O
DIGITAL SIGNATURE BS O
ENCRYPTION ALGORITHM ID RT O
ENCRYPTION KEY ID RT O
FATHER RECORD PERSON AG O
FATHER RECORD PERSON MAJOR RECORD AG M
IDENTIFIER
FATHER RECORD PERSON MII 2 R M
FATHER RECORD PERSON COUNTRY 3 C M
FATHER RECORD PERSON ISSUER ID 5 R M
FATHER RECORD PERSON CHECK DIGIT 1 R M
FATHER RECORD PERSON RECORD ID NUMBER 21 S M
FATHER RECORD PERSON SOCIAL SECURITY AG O
NUMBER
FATHER RECORD PERSON SOCIAL SECURITY NUMBER 2 R M
MII
FATHER RECORD PERSON SOCIAL SECURITY NUMBER 3 C M
COUNTRY
FATHER RECORD PERSON SOCIAL SECURITY NUMBER 5 R M
ISSUER ID
FATHER RECORD PERSON SOCIAL SECURITY NUMBER 1 R M
CHECK DIGIT
FATHER RECORD PERSON SOCIAL SECURITY NUMBER 21 S M
RECORD ID NUMBER
FATHER RECORD PERSON ALTERNATIVE RECORD AG O
NUMBER
FATHER RECORD PERSON ALTERNATIVE RECORD 2 R M
NUMBER MII
FATHER RECORD PERSON ALTERNATIVE RECORD 3 C M
NUMBER COUNTRY
FATHER RECORD PERSON ALTERNATIVE RECORD 5 R M
NUMBER ISSUER ID
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CAG O
ID AUTHENTICATE DATA
ID AUTHENTICATE METHOD C M
ID AUTHENTICATE KEY 512 BS M
CERTIFICATE CAG M
AUTHENTICATION CERTIFICATE VERSION SERIAL S M
NUMBER
CERTIFICATION ALGORITHM IDENTIFIER BS M
CERTIFICATION ALGORITHM PARAMETERS BS O
CERTIFICATION AUTHORITY S M
AUTHENTICATION CERTIFICATE VERSION VALIDITY NOT 12 D M
BEFORE
AUTHENTICATION CERTIFICATE VERSION VALIDITY NOT 12 D M
AFTER
HCP ID NUMBER S M
ALGORITHM IDENTIFIER BS M
PUBLIC KEY BS M
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CODED DATA AG O
CODING SCHEME REF. RT M
CODE DATA VALUE S M
CODE DATA FREE TEXT S O
ACCESSORY ATTRIBUTES AG O
DATE 1 12 D O
DATE 2 12 D O
PLACE/PERSON 1 RT O
PLACE/PERSON 2 RT O
PLACE/PERSON 3 RT O
PERSON 3 TEXT 30 S O
OBJECT SECURITY ATTRIBUTES AG O
SIGNATURE ALGORITHM ID RT O
SIGNATURE KEY ID RT O
DIGITAL SIGNATURE BS O
ENCRYPTION ALGORITHM ID RT O
ENCRYPTION KEY ID RT O
LINKAGES CAG
LINK SRT M
HCP DATA AG
HEALTH CARE PERSON AG M
HEALTH CARE PERSON COUNTRY 3 C M
HEALTH CARE PERSON ID NUMBER 21 R M
HEALTH CARE PERSON NAME TITLE 7 S O
HEALTH CARE PERSON NAME SURNAME PREFIX 15 S O
HEALTH CARE PERSON PREFERRED SURNAME 27 S M
HEALTH CARE PERSON SURNAME 27 S M
HEALTH CARE PERSON SUFFIX 15 S O
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Annex G (informative)
EDIFACT representation of a sample of data objects
This European Prestandard defines the data structure of objects communicated to/from intermittently
connected devices. ASN.1 syntax is proposed in Annex B, Annex C, and Annex D for several reasons,
amongst them the fact that the object-oriented syntax allows a comprehensive and compact description of
a large number of possible data structures in a specific device whilst maintaining maximum flexibility,
according to various needs of the users of the standard. Another feature of the ASN.1 is that it allows for a
very compact coding according to ISO 8825:1990, very important for many machine readable cards where
memory space is a serious limiting factor.
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On the other hand EDIFACT syntax has been used widely to define messages between a variety of health
informatics systems for both clinical and administrative purposes due to its relative simplicity in
implementation and to the relatively wide spread knowledge of its use. It is very likely that data from ICDs
transferred according to this pre-standard will in many cases also be utilised in various applications that
will communicate with other health information systems using EDIFACT messages.
In order to facilitate the understanding of how such messages may be developed and the relation between
the ASN.1 format and the EDIFACT syntax description, the following text has been prepared.
The EDIFACT message outlined herein is not to be regarded as a standard; only as an example
to illustrate certain points of such implementations.
The actual future standardisation of EDIFACT messages for health care follows other routes and priorities
and it is specifically not recommended that particular ICD EDIFACT messages are created at this point.
The ICD data will however be available for use by several applications that need to create EDIFACT
messages according to current and future standards in various fields.
Most of the data objects of this European Prestandard may be transferred to EDIFACT syntax with few
problems, particularly when the possible variability of the standard has been reduced to a real life
implementation profile, making selections among the many options. There are however a few structures
that can not be correctly described in EDIFACT and some of these are pointed out below.
For the purpose of this exercise the scenario of data from a card designed to be used in an emergency
situation will be used. Data considered will primarily be used in identifying the individual, his carer,
payment provisions in terms of the E111 document and the very limited clinical emergency data set from
the European Emergency Health Care Card. For the sake of simplification this data and the other data
contained within the device have no access restrictions.
To conform to this European Prestandard the whole ICD-application should be considered to conform when
transferring the relevant data objects to the ICD-application. Assume that this application requires to
transfer data to another system for further consideration. It may for instance be the case that the
ICD-system is located in an ambulance and that the data from the emergency card is subsequently going
to be transferred to the nearby hospital using radio link and EDIFACT message syntax.
The relevant objects using the ASN.1 format are considered first. A hypothetical Emergency Card Data Set
is created from the relevant objects of the standard to encompass the totality of the data needed for this
application. The EmergencyCardDataSet used in this illustration is not itself part of the prestandard but
its component objects are taken directly from the Prestandard and reproduced here to provide a complete
illustration.
EmergencyCardDataSet 4 SET
{
RecordPerson [0]
RecPersVariableID [1]
ContactPerson [2]
Responsible Physician [3]
PaymentProvisions [4]
LimEmergDataSer [5]
}
{
RecordPerson [0]
MajorRecordIdentifier [0]
mII [0] NUMERIC STRING DEFAULT 80
(SIZE(2)),
issuerCountry [1] Country,
issuerIdentifier [2] NUMERIC STRING (SIZE(5)),
checkdigit [3] NUMERIC STRING (SIZE(1)),
-- Calculated according to Luhn
recordIdNumber [4] EvolRecordIdentifier
AlternativeRecordIdentifiers[1]
SocialSecurityNo [0]
mII [0] NUMERIC STRING DEFAULT 80
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(SIZE(2)),
issuerCountry [1] Country,
issuerIdentifier [2] NUMERIC STRING (SIZE(5)),
checkdigit [3] NUMERIC STRING (SIZE(1)),
-- Calculated according to Luhn
recordIdNumber [4] EvolRecordIdentifier
RecordIdVerification [2]
RecordPersonName [0] Fullname,
DateOfBirth [1] Date,
SexAtBirth [2] OCTET STRING (SIZE(1),
-- ISO 5218
PlaceOfBirth [3] Place
[4] AccessoryAttributes OPTIONAL
RecPersVariableID [1]
Address [0] Address OPTIONAL,
PreviousAddresses [1] SEQUENCE OF Address OPTIONAL,
ContactPerson [2]
name [0] Fullname,
ContactTelno [1] Telecom,
comment [2] OCTET STRING(SIZE(0..20))
OPTIONAL
[3]AccessoryAttributes OPTIONAL
HealthCarePerson [3]
HCPCountry [0] Country
HCPIdNo [1] NumericString (SIZE(1..21)),
HCPName [2] Fullname,
HCPRelationCode [3] CodedData OPTIONAL,
-- This is a code that would indicate things like
-- Primary responsible General Practitioner Specialist,
-- consultant, etc.
HCPClass [4] Sequence of BOOLEAN,hcpProfession
[5] SEQUENCE OF HcpProfCode OPTIONAL,
-- This will allow national codes for exact definitions of
-- various HCP groups.
HCPEmploymentNo [6] BitString OPTIONAL,
HCPEmploymentData [7] SEQUENCE OF CodedData OPTIONAL
PaymentProvision[4]
PaymentBodyID [1] SEQUENCE
PaymentBodyCountry [0] Country,
-- This represents the country of the Payment
-- BodyNumber
-- The country of address may be different
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Policy 4 SET
PolicyIdNo [0] OCTET STRING(SIZE(0..21))
MemberNo [1] OCTET STRING(SIZE(0..15))
OPTIONAL
CoveredPersonConditions [2] SET OF PersonCondition,
PersonCondition 4 SEQUENCE
RecPersPointer [0]RecPersPointer,
Conditions [1] SET OF Condition
Condition 4 SEQUENCE
ObligatoryStatus [0] BOOLEAN OPTIONAL,
-- True means obligatory
CareCoverageCode [1] SET OF CoverageCode
OPTIONAL,
CareCoverageText [2] OCTET STRING (SIZE(0..20)
OPTIONAL
CoverageAreas [3] SET OF Country OPTIONAL
PaymentLevel [4] SEQUENCE
LowerLimitCoverage [0] Money OPTIONAL,
-- The value above which provisions are valid
UpperLimitCoverage [1] Money OPTIONAL,
-- The value under which provisions are valid
BenefitsRate [2] INTEGER OPTIONAL,
-- Percentage of coverage
SetPrice [3] BOOLEAN OPTIONAL,
-- True means a SetPrice (fixed for the service exists)
SetPricevalue [4] MONEY OPTIONAL
ThirdParty [5] BOOLEAN OPTIONAL,
-- True means the payment body pays direct
EmploymentStatus [6] SET OPTIONAL,
Employed [0] BOOLEAN,
SelfEmployed [1] BOOLEAN,
EmployedPensionabl [2] BOOLEAN,
SelfEmployedPensionable [3] BOOLEAN
-- True means status applicable according to ECU
-- E 111 form
AuthorisationReq [7] BOOLEAN OPTIONAL,
-- True means authorisation by payer required.
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EmergencyData [5]
EmergencyDataBitMap [0] SEQUENCE OF BOOLEANS
Asthma [0]
HeartDisease [1]
EpilepsyFits [2]
NeurologicalDisorder [3]
Haemophilia [4]
ClottingDisorder [5]
Diabetes [6]
Glaucoma [7]
DialysisTreatment [8]
Transplant [9]
MissingOrgan [10]
PacemakerInSitu [12]
AntipsychoticMedication [13]
Anticonvulsants [14]
Antiarrythmics [15]
BloodPressureDrugs [16]
Anticoagulants [17]
AntidiabeticAgents [18]
Antihistamines [19]
[1] AccessoryAttributes OPTIONAL
The data dictionary for such an implementation is illustrated in Table G.1.
Table G.1 — Data dictionary illustration
TITLE FIELD FIELD TYPE M
LENGTH O
RECORD PERSONS CAG M
MAJOR RECORD PERSON AG M
MAJOR RECORD IDENTIFIER AG M
MAJOR RECORD PERSON MII 2 R M
MAJOR RECORD PERSON COUNTRY 3 C M
MAJOR RECORD PERSON ISSUER ID 5 R M
MAJOR RECORD PERSON CHECK DIGIT 1 R M
MAJOR RECORD PERSON RECORD ID NUMBER 21 S M
MAJOR RECORD PERSON SOCIAL SECURITY NUMBER AG O
MAJOR RECORD PERSON SOCIAL SECURITY NUMBER MII 2 R M
MAJOR RECORD PERSON SOCIAL SECURITY NUMBER 3 C M
COUNTRY
MAJOR RECORD PERSON SOCIAL SECURITY NUMBER 5 R M
ISSUER ID
MAJOR RECORD PERSON SOCIAL SECURITY NUMBER 1 R M
CHECK DIGIT
MAJOR RECORD PERSON SOCIAL SECURITY NUMBER 21 S M
RECORD ID NUMBER
MAJOR RECORD PERSON RECORD ID VERIFICATION AG M
MAJOR RECORD PERSON FULLNAME AG M
MAJOR RECORD PERSON TITLE 7 S M
MAJOR RECORD PERSON SURNAME PREFIX 15 S M
MAJOR RECORD PERSON PREFERRED SURNAME 27 S M
MAJOR RECORD PERSON SURNAME 27 S O
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SIGNATURE ALGORITHM ID I O
SIGNATURE KEY ID I O
DIGITAL SIGNATURE BS O
ENCRYPTION ALGORITHM ID I O
ENCRYPTION KEY ID I O
HEALTH CARE PERSON AG M
HEALTH CARE PERSON COUNTRY 3 C M
HEALTH CARE PERSON ID NUMBER 21 R M
HEALTH CARE PERSON NAME TITLE 7 S O
HEALTH CARE PERSON NAME SURNAME PREFIX 15 S O
HEALTH CARE PERSON PREFERRED SURNAME 27 S M
HEALTH CARE PERSON SURNAME 27 S M
HEALTH CARE PERSON SUFFIX 15 S O
HEALTH CARE PERSON PREFERRED FORENAME 27 S M
HEALTH CARE PERSON FORENAME 27 S M
HEALTH CARE PERSON RELATION CODE C O
HEALTH CARE PERSON CLASS 10 B M
HEALTH CARE PERSON PROFESSION SC O
HEALTH CARE PERSON EMPLOYMENT NO BS O
HEALTH CARE PERSON EMPLOYMENT DATA SC O
PAYMENT PROVISION AG M
PAYMENT BODY ID AG M
PAYMENT BODY COUNTRY C M
PAYMENT BODY NUMBER 9 S M
PAYMENT BODY NAME 20 S O
PAYMENT BODY ADDRESS AG O
PAYMENT BODY POSTAL ADDRESS S M
PAYMENT BODY EXT HEALTH CARE ADDRESS S M
PAYMENT BODY POST CODE 8 S M
PAYMENT BODY COUNTRY 3 C M
PAYMENT BODY TELECOM AG O
PAYMENT BODY TELNO 15 R O
PAYMENT BODY TELNO OTHER 15 R O
PAYMENT BODY FAXNO 15 R O
PAYMENT BODY X.400 ADDRESS 30 S O
POLICIES CAG M
POLICY AG M
POLICY ID NO 21 S M
MEMBER NUMBER 15 S O
COVERED PERSON CONDITIONS AG M
OBLIGATORY STATUS 1 B O
CARE COVERAGE CODE SC O
CARE COVERAGE TEXT 20 S O
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In the application illustrated by Table G.1 it is assumed that the implementors wish to conform to this
pre-standard and require the eventual ability to share data with other systems, thus designing their data
models as per the standard.
To be conformant with the original user requirement, the implementors will strip the data set of all
accessory attributes and security functions thereby providing the simplest system (with unprotected access
to data as already assumed). However they appreciate that the use of EDIFACT as the medium of
communication between the CAD and host renders certain data types inadmissible, so they will lose the
functionality of differential access to data. (Also if the system were to be implemented via a microprocessor
card with security functions then their application would not be able to access the bulk of the data on such
a card.) Furthermore, all data which is coded using coding systems not mandated by this standard will not
be interpreted by their application, and all fields with no upper limit defined within the standard will also
be inadmissible.
On these assumptions, the designed EDIFACT message between CAD and host is shown in Table G.2.
NOTE There exists the possibility for eight Boolean values per byte.
Table G.2 — EDIFACT message representation between CAD and host
NR DATA ELEMENT NAME LN TY END O/M
POS.
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