HL7 Version 3 Impact Assessmentt

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HL7 Version 3
An impact assessment
Information for Personal Health
V1.0 March 2001
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Purpose of this document
To assess the implications of HL7 version 3 on
clinical messaging within the NHS. In particular
implications for strategy, terminology, drug
databases, and UK models.
Distribution
NHSIA Website
Authors
David Robinson, Paul Frosdick, Els
Briscoe
David Robinson,
NHS IA,
Aqueous 2
Rocky Lane
Aston Cross
Birmingham
Further copies from
B6 6RQ
E-mail: david.robinson@nhsia.nhs.uk
IA Reference
Number
2001-IA-566
Date of issue
23rd March 2001
Revision History
© Crown Copyright 2001
Published by the NHS Information Authority
on behalf of the NHS Executive.
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HL7 Version 3 Impact Assessment
1.
INTRODUCTION ............................................................................................................................. 4
2.
HL7 VERSIONS ............................................................................................................................... 6
3.
RELATED ORGANISATIONS AND STANDARDS ........................................................................ 9
4.
HL7-UK .......................................................................................................................................... 11
5.
USE OF HL7 AND THE UK HEALTHCARE MARKET ................................................................ 12
6.
THE HL7 REFERENCE INFORMATION MODEL VERSION 3 .................................................... 13
7.
THE MESSAGE DEVELOPMENT FRAMEWORK ....................................................................... 17
8.
CLINICAL TERMINOLOGY .......................................................................................................... 20
9.
SUMMARY .................................................................................................................................... 25
10. NEXT STEPS ................................................................................................................................. 26
APPENDIX A
GLOSSARY ................................................................................................................ 28
APPENDIX B
ACKNOWLEDGMENTS............................................................................................. 29
APPENDIX C IMPLICATIONS FOR THE UK THE HEALTH CARE MODEL ................................... 30
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1. Introduction
Health Level 7 (HL7) (www.hl7.org) is a clinical interface standard, the 7 refers to the 7th
(application Layer) of the International Standards Organisations (ISO) Open Systems
Interconnection (OSI) Reference Model for networks. This layer includes protocols for file
transfer, and is the prime focus for HL7.
HL7 was formed in 1987 in the USA to develop standards for electronic interchange of
clinical financial and administrative information between different clinical and supporting
systems. Within the application layer HL7 is concerned with definitions of data, timing of data
exchange and error handling. The stated goals of the standard include:
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The standard should support exchanges in the widest variety of technical
environments
The greatest possible degree of standardisation possible should be achieved,
although site-specific variations should be accommodated
The standard should support evolutionary growth
The standard should not favour interest of specific companies
The standard should define formats for all healthcare environments
Decisions are made by consensus balloting
Co-operation with other related healthcare standards is a stated priority
The HL7 working group has met approximately every 4 months since 1987. The group is
structured into a number of Technical Committees (TCs) each concerned with particular
aspects of the standard. There is overlap between many of these committees, and joint
meetings are also held during working group meetings.
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Architecture Review Board
Clinical Context Object Workgroup
Clinical Decision Support
Control Query
Education & Implementation
International Affiliates
Medical Records/Information
Modelling & Methodology
Orders/Observations
Patient Administration/Finance
Patient Care
Publishing
Scheduling & Logistics
Clinical Document Architecture
Vocabulary
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In addition to the technical committees there are a number of Special Interest Groups
(SIGs), these include:
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Arden Syntax
Blood Bank
Community-Based Health Services
Conformance
Guideline Interchange Format
Imaging Integration
Laboratory, Point of Care and Automated Testing
Security And Accountability
Clinical Templates
XML
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2. HL7 Versions
2.1. Version 1
The Version 1.0 draft standard was presented in October 1987. The available timeframe did
not permit the standard to address all the recognised issues.
2.2. Version 2
The prototype Version 2.0 was prepared following Version 1.0 and was first presented in
1988. There have been a number of subsequent revisions:
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2.0
2.1
2.2
2.3
2.3.1
2.4
(1988)
(1990)
(1994)
(1997)
(1998)
(2000)
Prototype
First standard
Widely adopted
Most widely used current ANSI standard
Current ANSI standard
Current ANSI standard
V2 includes message standards covering: patient admission, discharge, transfer and
registration, scheduling, order entry, patient accounting (billing) systems and clinical
observation data, such as laboratory results, that are sent as identifiable data elements
(rather than display oriented text).
2.3. Version 3
Since 1996, HL7 has been working on a new generation of standards known as Version 3.
The motivation for Version 3 arises from known implementation difficulties with Version 2.
The multi-disciplinary efforts to achieve a workable and in-use Version 2 standard have
resulted in:
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Complex integration process
Misunderstanding of specifications
Different and implicit information models
Difficulty in verifying conformance
Difficulty in measuring progress
Widespread optionality
Lack of explicit support for new technologies
Object oriented technologies
Extensible Mark-up Language (XML)
Web technologies
Lack of explicit support for security functions
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Version 3 differs from Version 2 in that all standards developed will arise from an underlying
Reference Information Model (RIM). Messages will be developed according to a defined set
of development requirements, the Message Development Framework (MDF). The aim is to
produce consistency in definition of different information objects and their representation in
messages, thus allowing for easier implementation and the definition of clearer conformance
requirements. Furthermore, the underlying modelling approach allows for the definition of
standards for information representation other than just messages including documentary
forms, decision-support mechanisms and electronic patient record structures.
The process of HL7 can be defined in terms of deliverables within 4 phases. The process
follows standard software development stages, and the methodology follows the Unified
Modelling Language (UML):
Analysis
Use Case Model
Information model
Reference Information Model
Domain Information Model
Vocabulary Domain Specification
Design
Interaction Model
Message Information Model (MIM)
Hierarchical Message Description (HMD)
Voting & Publishing
HL7 Management
Implementation guide
Implementation Technology Specification (ITS)
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Use case model
Identifies:
 Healthcare requirements
 Actors and events
 Scope
Information model
Drawn from:
 RIM
Models new concepts
Harmonise with the RIM
Produces:
 Class diagram
 State diagram
Interaction model
Drawn from:
 Use case model
Defines:
 Trigger events
 Interactions
Creates:
 Conformance claims
Message design
Drawn from:
 Interaction model
 Information model
Develops:
 Message information model (MIM)
 Refined message information
model (RMIM)
 Hierarchical message description
(HMD)
Figure 1: Summary of message development process
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3. Related organisations and standards
3.1. CEN TC251
CEN is the Committée Européan de Normalisation, Technical Committee 251 (CEN TC 251)
have produced a number of standards relating to messages e.g.
ENV 13606 1-4
Electronic healthcare record communication
ENV 1613
Messages for exchange of laboratory information
There has been considerable input from players within CEN TC251 and there are ongoing
processes to harmonise work within CEN and HL7. Implementation of CEN standards has
been limited.
3.2. ISO TC215
The International Standards Organisation (ISO) Technical Committee 215 was established in
1998 to support “standardisation in the field of information for health…and to reduce
duplication of effort and redundancies”.
There are a number of ongoing work items with the TC, but no standards for clinical
messaging. Under the Vienna Agreement ISO TC215 and CEN TC251 will not engage in
parallel work activities.
3.3. CORBAmed
CORBAmed is the Healthcare Domain Task force of the Object Management Group (OMG)
which promotes the use of Object oriented Methodologies. CORBAmed therefore presents
an alternative way of integrating a medical record through software components. Its focus is
therefore on software components, but does identify a need for an integrated presentation of
the medical record.
3.4. GEHR
The Good Electronic Health Record (www.gehr.org) is an evolving health record architecture
based on the Good European Health Record Project (www.chime.ucl.ac.uk/HealthI/GEHR ).
Trials are currently taking place in Australia in transforming records to GEHR format,
including pathology and radiology data. This work will maintain compatibility with HL7 and is
inputting into HL7 itself. Although GEHR is not in itself a standard, the original GEHR
influenced work within CEN.
3.5. HISA
The Healthcare Information Systems Architecture originated from CEN (ENV 12967). It
persists primarily as middleware services, including generic and specific healthcare
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categories. These are published as information models and service interaction definitions.
Information systems have been developed based on HISA in Europe and the Middle East.
3.6. SynEX
The SynEX consortium, with support from the Telematics Applications Programme of the
European Commission produced an open, generic solution for communicating and sharing
records. SynEX enables authorised persons to share and present medical records from any
system in any place, and assists them in understanding their clinical significance. SynEX is
offered as a set of components and these deal with issues such as security and
authorisation, terminology and protocols. Data exchange uses XML as preferred method but
also covers data exchange using HL7.
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4. HL7-UK
HL7-UK (www.hl7.org.uk ) is an official affiliate of HL7, membership includes
representatives of:
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Primary and secondary system suppliers
Universities
Consultancies
NHSIA
ACIG
Health Authorities
NHS Trusts
Pharmaceutical knowledge base providers
The Royal Pharmaceutical Society of Great Britain
The mission statement of HL7-UK is:
“To support the development, promotion and implementation of HL7 standards in ways
which meet the needs of healthcare organisations, health professionals and healthcare
software suppliers in the United Kingdom. “
The policy of HL-UK is to:
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Work within HL7 to ensure its fitness for purpose in the UK
Identify those HL7 standards that are directly applicable to UK healthcare and those that
require adaptations or national implementation guidelines to meet UK requirements
Propose solutions that meet the need for consistent national implementation, while
avoiding the need for massive changes to systems and unnecessary divergence from
HL7 standards
Ensure the RIM can capture record architecture principles
Facilitate agreement between the boundaries of responsibility between modellers and
terminology maintenance organisations
Historically there are have been 2 sub-groups within HL7-UK:
HL7-UK Version 2 subgroup
Concerned with supporting consistent implementation of HL7 Version 2 for use within NHS
trusts.
HL7-UK Version 3 subgroup
Concerned with ensuring that HL7 Version 3 development meets the needs for widespread,
effective communications within and between UK healthcare institutions.
For the last eight months there has only been one group, the Technical Sub-group. This
group is divided ‘virtually’ into a number of interest groups that communicate via a list server.
One of the most active of these is drafting the Version 2 implementation guide.
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5. Use of HL7 and the UK Healthcare Market
Version 2 of the HL7 standard now has a widely installed base across many countries
outside the USA, including Canada, Australia, Japan, New Zealand, Germany, the UK, the
Netherlands, Finland, South Africa, Argentina and India. All these named countries have
national affiliate organisations to the parent body of HL7.
5.1. Primary Care
The UK primary care Clinical Information System (CIS) market is relatively well developed
and controlled, with approximately 85% of users being supplied by three main system
suppliers. Products have usually been developed within the UK, although the owners of such
systems may be from outside the UK. There has been input from primary care clinicians into
the development of these systems.
Some suppliers have been active within CEN TC251, and have contributed to standards
arising from that body. Some are active within HL7-UK, however it is felt to be unlikely that
the majority of suppliers will re-tool to HL7 without a strong business case, which currently
does not exist.
5.2. Secondary Care
The UK Industry for clinical information systems within Secondary Care has a much higher
proportion of international companies, with many of these systems being US-based. There
are a number of smaller enterprises who are potentially disadvantaged by the lack of a
universal standard.
The business requirements within this segment place emphasis on intra-organisational use,
and a requirement for automated production of data to support central returns and internal
governance. Clinicians who use systems have slightly differing requirements, e.g. real-time
use and decision support, however the two requirements cannot be divorced.
International companies, especially those that are US-based, are likely to be compliant with
some version of HL7, most probably version 2.3. HL7 Version 2 is used in at least two of the
major suppliers in the UK. They are unlikely therefore to subscribe to alternative standards
such as those arising from CEN TC251 unless they are mandated, the business case from
the UK market for these companies is unlikely to be sufficient to support this.
5.3. NHS Information Authority
The NHS Numbers for Babies project (www.nhsia.nhs.uk/nn4b) is using HL7 Version 2.3, in
messages between Maternity Units and the Central Issue System and Child Health. This
was specified in June 2000.
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6. The HL7 Reference Information Model version 3
This report provides an assessment of the usefulness of the HL7 Reference Information
Model (RIM) for current developments in the NHS more specifically the recommendations of
Information for Health. The NHS Information Authority’s Health care Model (HcM) has been
used as a check list to assess the HL7 RIM not because it is believed to be a better or more
complete model but because it does incorporate knowledge of years of clinical application
development in the NHS. A detailed comparison between the two models has been included
in Appendix C. The main focus of the work has been to find answers to the following
questions:
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Is the HL7 RIM a stable information model?
Is the HL7 RIM able to support both message development and interface design?
How well does HL7 support the clinical scope?
6.1. Status and stability of the HL7 RIM version 3
The current version of the model contains a considerable amount of open issues. These
include issues about the definition of classes and their attributes and the recognition that
some classes and attributes will need to be removed and their functionality incorporated into
other classes. It is not made clear what the relation of the USAM model version 2.6 is to this
version of the RIM. The RIM refers for information about important attributes to the USAM
model (no version number included) but does not take on board all of the classes in the
USAM model1. The RIM Version 3 is expected to undergo extensive revision as and when
messages are developed to support clinical requirements. An indication of the
developmental nature of the RIM is that it has already passed version 100, this instability is a
natural feature of the development phase and offers an opportunity for the NHS to
participate in development.
6.2. RIM, message development and interface design
The RIM is an essential part of the HL7 Version 3 development methodology, as it provides
an explicit representation of the semantic and lexical connections that exist between the
information carried in the fields of HL7 messages. The RIM is there to support the
development of messages. To date, no messages have been developed for Version 3 and
as such the model has not yet been tested, it is expected that this will start to happen in the
near future. HL7 Version 3 interfaces between systems via messages, however there are
viable alternatives to support electronic communication between systems such as standard
interfaces developed by OMG and SynEX. The NHS faces the task of implementing the EHR
and indications from the Electronic Record Development and Implementation Programme
(ERDIP) projects are that the functionality required will not be able to be supported solely by
messages. Common interfaces will need to be developed.
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For instance the class Condition Node.
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6.3. The RIM and clinical scope.
6.3.1. Security / confidentiality
This most important component of any clinical information system and a crucial factor in the
realisation of an EHR has not received a great deal of attention in the model. Confidentiality
is expressed as a coded 2 attribute of a limited number of classes such as Act and Clinical
Document. Therefore, because the RIM does not deal with security for the total of the clinical
record, the security requirements for EHR would not be met in this version of the RIM. It is
worth noting that there are structures available for this and one ought to be included within
the RIM. There is recent evidence that HL7 shares this view.
6.3.2. Clinical reasoning ( the Activity class)
There are limitations in ability of the RIM to express the clinical reasoning process. In
clinical reasoning it is necessary to focus attention on a specific property of a patient
(symptom, measurement, result), then assign an intention to it, before identifying specific
activities to change/understand it. The RIM cannot do this because the Act class
incorporates the results of the Act within its specification. This has a number of implications.
These include the fact that it restricts the ability to look at patient characteristics separately
from the activity observing them. It requires knowledge of the results of an activity before it is
undertaken. It does not allow for instance a single observing activity to observe multiple
properties. It also makes it difficult to relate clinical findings to one another since it is always
the activity that is being related.
The RIM does not include certain activity states which are particularly important when
dealing with referrals in the context of the NHS. The mood_cd attribute and state attribute of
Act do not cover several activity states distinguished in the HcM. These omissions include
performer accepted activity, performer selected activity, performer rejected activity and
performance rejected activity.
The RIM currently can only represent repeat prescribing and self-treatment with difficulty.
The specification of repetitive activities is incomplete with the sole attribute
maximum_repetition_nbr in the Act class.
The complex relationship between activities has been generalised in the many-to-many
Act_relationship class. The definition of the relationships is poor and overly complicated as it
is trying to also cater for the complex relationship between individual patient observations
(results).3
6.3.3. Consent
Clinical consent is a complex matter, often qualified and conditional. Because in the RIM,
consent is viewed as an Act but with no additional attributes or associations for this activity
nor for the resulting consent, it is limited in its ability to handle this issue. It is not possible to
talk about the consent without referring to the activity of giving consent This makes it difficult
2
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HL7 has a specific set of confidentiality codes.
Please refer to appendices for further detail.
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to store information particular to that consent such as which activities were consented to, if
consent was withdrawn or conditional to certain health care practitioners.
6.3.4. NHS number and other identifiers
All health systems have to deal with multiple patient identifiers. In this country there are the
NHS number, PAS numbers, GP practice numbers, lab numbers etc.. Similarly in the US, all
health providers have their own patient identifier (although their Government is planning to
create a unique national health number). In order to deal with multiple identifiers, it is
necessary to know which identifier is associated with which institution or practitioner and
whether it is currently valid. The RIM does not currently handle this.
The class Entity_name is an attempt to create identifiers, however it does not refer to any
context. There is no reference to the state of the Entity_name which may no longer be valid
and there is no association with the Agent that may prefer to use this name. Therefore it is
difficult to distinguish between the many entity names an entity may have. The unique
identification of the patient required for EHR would not be possible if this class is used.
Alternatively the Id attribute of Entity could be used but the RIM states it is not to store
information about the kind or type of entity this is, so no reference to NHS patients can be
made to distinguish this identifier.
6.3.5. Places and locations
Place is a subtype of Entity and hence inherits its attributes. However it is only used as the
location for an encounter. It is not currently possible to link a patient (person) with several
locations/places as they move through a process of care (information needed for booking of
ambulances, porters, etc). Additionally it is not possible to link a person with several
addresses or contact numbers or to document the relationship places have with one another.
6.3.6. Roles, participation and responsibilities
The RIM makes it complicated to represent that patients are treating themselves. A patient
would need to take on a Role of Healthcare practitioner, which seems to be an abuse of the
concept. The attributes for the class Health care practitioner refer to qualifications.
The relationship between roles has been generalised in the Role_relationship class. This
forces one to create a role for an Entity in order to express a relationship between two
entities for instance the relationship between the patient (living subject) and his/her sample.
No direct relationship between entities can be expressed. This is particularly significant in
the transplant arena.
Role relationship can not be further qualified through its attributes.
The specification of the Role class does not include an indication if the role was authorised
and by whom. No chain of devolved responsibility exists. No distinction has been made
between those roles which have been authorised and those that are not subject to
authorisation.
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6.3.7. Health Chart
A Health chart (patient health record) is composed of health chart deficiencies. There is no
definition what a deficiency is and this lack of clarity makes it impossible to assess what this
class means and how it would be implemented.
6.3.8. Encounter_drg
There is no association in the model between the class Encounter_drg and
Patient_encounter to which the first relates. The concept of DRG closely assembles the
HRG coding that takes place in the NHS but further investigation of the attributes of this
class may be needed to ensure adequate use in the NHS.
6.3.9. Knowledge
The RIM classes document the knowledge level within the same classes as would be used
to record individual patient information. This severely restricts its use. How would one
represent genus/species relationships between concepts and categories? Where do
protocols and guidelines fit within this model?
As the RIM currently exists, it appears that the use of attributes and code sets within classes
to represent knowledge will make it difficult to take on board SNOMED CT.
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7. The Message development framework
7.1. Overview of the HL7 MDF
The HL7 Version 3 MDF is a methodology describing the generic tasks which must be
undertaken in order to produce a set of technical products, to wit EDI message
specifications. The philosophy is that by following the steps rigorously, high quality products
will emerge. The MDF has evidently been conceived in a system4 development context in
that the method has distinct similarities in approach to other system development
methodologies (SSADM, Information Engineering etc), and much of the methodology is
familiar from elsewhere. UML modelling constructs are used almost exclusively: relying on
storyboards and Use Cases to capture the processes which are being performed, Interaction
and Sequence diagrams to show the detailed processing, Class and State diagrams to
indicate the information classes and their behaviour. The use of Use Cases both within the
method and as a means of describing it (a metamodel) highlights one of the weaknesses of
the technique in that the connections between Actors and Use Cases cannot have their
content described (e.g. in terms of Classes). There is also no conception of sequence in the
notation. The HL7 RIM is used as a standard Information Model for the process, and a
description is given of how the Rational Rose CASE tool is extended and used to support the
method.
The method falls into four major stages:
Stage
Identify the Message Requirements
Identify the Message Contents
Specify the Messaging Behaviour
Build the Message Specification(s)
Principal Product
Use Case Model
Information Model
Interaction Model
Message Design Model
A detailed worked example of using the methodology for generating a message set dealing
with patient encounters is provided but it is not made clear whether this is hypothetical or is a
real example.
The document is a substantial piece of work and clearly much effort has gone into its
development and production.
7.2. Scope of the MDF
The MDF describes a set of processes necessary to develop the specification for a set of
one or more messages from the point at which the messages have been considered
necessary to the point at which the specification is complete. It does not describe processes
for:
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Identifying the business requirement, and attaching relative priorities
Ensuring that the products generated are of appropriate quality5
Prototyping, testing and implementation of the messages
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The word system is used in its widest sense throughout this document to mean any electronic
mechanisms to support business processes.
5 There is a reference to the Architecture Review Board but this seems to be post-hoc and to have
few if any teeth.
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Supporting roll out
7.3. Some features of the Methodology
7.3.1. Approach
The process described in the manual does not recognise the benefits which can be gained
by adopting a rapid development approach, i.e. by multiple iterations of some processes,
and by using the early results of testing, prototyping and simulation to feed back into the
specification process. The result is that once the message requirements were defined that
these would remain constant for the whole of the process. There is no mention of prototyping
and how that may affect the requirements specification.
7.3.2. Modelling the Business
The MDF displays (along with many other methodologies) a weakness. It does not address
the question of “What should we be building” based on an understanding of the business
which the system is intended to support. One lesson, which has been learnt the hard way by
many a system developer, is that the most difficult task is understanding the working of the
environment into which any system is to be installed, and how the system is intended to
support that environment. All too often, assumptions are made about that environment and
although the process of designing and building the system may be of the highest quality, if it
does not support the business it is wasted effort.
An effective way of understanding the business is to model the processes which are
undertaken with no preconceptions as to which of these may be supported (or indeed
partially or completely performed) by IT systems. This understanding can then be used to
identify which business processes need to be supported by technology, and the nature of
this support. This provides a sound basis for taking forward the processes described in the
MDF such as storyboarding and Use Cases. It also helps to ensure that, especially if a
consistent business model is adopted, messages developed by different technical
committees are consistent in their approach and use of data.
The MDF could therefore be substantially improved by the adoption of such a business
model describing the processes of delivering healthcare, and its incorporation into the earlier
stages of the method.
7.3.3. Scaleability
A United States oriented approach is evident in some areas, for example the statement on
p5-18 of the MDF “....one can not expect that Location objects be tracked individually by
information systems, and one can not expect that information systems could know about all
persons associated with the same physical location”. In the UK this is precisely what many
systems do by means of the Post Office Address File (PAF). The RIM view in this case
weakens the model by making an address merely an attribute of Stakeholder (the supertype
of Person). This also has the drawback that only a single address can be so associated,
precluding both multiple concurrent addresses of different types (home, work, weekend
cottage) and the retention of a history with the timepoints at which each became effective.
Similar points may be made regarding other characteristics e.g. educational status, marital
status.
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7.3.4. Subject Classes
One concept, which is central to the methodology and the identification of messages, is that
of the “subject class”. This is defined as “...a class the committee designates as the central
focus of a collection of messages.” The document goes on to say “Identifying class states
and state transitions specifies behavioral characteristics of a class. Class states and state
transitions are defined for subject classes.” In other words, only where a class’s state
behaviour can be defined would it form the basis for a group of messages. However, it is
quite possible that the change of one of the attributes described for Person may be a
candidate for such a message - let us take the previous example of a person’s home
address. Change of such demographic details would quite feasibly be the topic for a
message. It seems unlikely that the mere change of the value of an attribute would be
considered as a state change as the state machine would be of little interest:
Person
change address
In Progress
Figure 2: Change of demographic details state chart
7.3.5. Metamodels
A series of metamodels describing the MDF in UML Class notation is provided, giving a very
useful view of the concepts being dealt with. There are however a few limitations in this (e.g.
the association between Subject_class and State is described as 1 to 0..* rather than 1..* (or
indeed 2..* to avoid triviality.
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8. Clinical Terminology
8.1. SNOMED Clinical Terms
SNOMED CT (www.nhsia.uk/clin_term/snomedct), is a new clinical terminology currently in
development through a collaborative project run jointly by the NHS Information Authority (on
behalf of the National Health Service throughout the United Kingdom and the College of
American Pathologists (CAP) in the United States of America. The project’s key deliverable
is to create a new terminology which, as a minimum standard contains a breadth of content
equivalent to the sum of its two constituent components; Clinical Terms Version 3 (The Read
Codes) produced by the NHS, and SNOMED RT produced by CAP.
Currently almost 2 years into a three-year programme, the new terminology is scheduled for
release on 10th December 2001. This scheduled delivery date was reinforced at the Editorial
Board of 09/10 February 2001, where it was reported that the product is still considered on
schedule at the time of reporting.
Information for Health discussed the need for SNOMED CT to be mandated for use within
the NHS, a situation that has been confirmed by statements with the strategies refresh
Building the Information Core published in January 2001. Section 1.7 introduces specific
time-scales for the terminology’s adoption across the service stating:
“By March 2003 - clinical information systems start to use SNOMED Clinical Terms”
a statement which is reinforced in Section 4.8 which says:
“Users/suppliers are advised not to develop new Read Code based systems from April
2003”
Section 4.7 outlines the strategic importance of SNOMED CT to NHS information policy by
saying:
“The use of a modern set of clinical terms underpins many aspects of the development
of health information systems . . . the development of SNOMED CT is being vigorously
supported”,
and is followed in Section 4.8 by the statement:
“After 1 April 2003 any computerised information system . . . should use the NHS preferred
clinical terminology, SNOMED CT”.
The proposed use of SNOMED CT in the UK means it is essential that the impact of HL7 on
the development of the terminology is considered:
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The impact of HL7 Version 3 on terminology use within the UK is related to the use of
terminologies and value sets within HL7. These can be considered in three areas:

Structural data - HL7 includes sets of codes representing structural constraints within a
message. These include ‘mood codes’ which provide additional information about the
meaning of a message, e.g. whether it refers to a test, its status or the results of the test.
There is potential for overlap with representation of Context of Care
(www.nhsia.uk/context) within SNOMED Clinical terms. it is important to ensure that
these facets of information within SNOMED Clinical terms can be represented within
HL7.

Small data sets – HL7 maintains a small set of coded data sets covering domains such
as site, ethnicity and healthcare professionals. These domains are also covered by large
scale vocabularies including SNOMED Clinical Terms These sets are maintained by
HL7, but are intended to be inclusive, it is important therefore that all SNOMED Clinical
Terms codes terms covering the UK realm are included.

Large-scale terminologies – HL7 has a process for registration of terminologies, covering
areas such as disorders, findings, procedures and drugs (considered in a separate
section). Currently Clinical Terms Version 3 is in the process of being registered.
SNOMED RT is already registered, and it is anticipated that SNOMED Clinical Terms will
be registered after its release in December 2001. HL7 has a datatype (CD –
Codephrase) which allows codes to be combined, This is consistent with the proposed
post-co-ordinated approach of SNOMED Clinical terms. However, some aspects of
information (e.g. negation, family history) likely to be represented by this mechanism in
SNOMED Clinical Terms are thought by HL7 to be sufficiently safety-critical as to require
explicit representation elsewhere within the message structure. These come under the
area of context of care, it is essential therefore that SNOMED Clinical Terms contextual
attributes and values are aligned with HL7.
8.2. Other vocabularies
8.2.1. LOINC
LOINC (Logical Observation Identifier Names and Codes) (www.regenstrief.org/loinc/) is a
terminology compiled and maintained by the Regenstrief Institute in Indianapolis. Initially it
aimed to ‘provide a set of universal names and ID codes for identifying laboratory test results
- to facilitate the exchange and pooling of clinical laboratory results, for clinical care,
outcomes management, and research’. Input has been predominantly from the USA, but
also from WHO, Sweden & Belgium.
Recently it has expanded into Clinical LOINC including:





Vital signs
CNS pressure monitoring
Intake and output
ECG measurements
Obstetric ultrasound measurements
It is updated quarterly, is free of charge, and is downloadable from the Internet. The LOINC
codes themselves are copyright.
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LOINC is in widespread use within the USA, and has had a considerable input into HL7. Its
use in the UK appears to be limited to a single laboratory. LOINC names go into more detail
than is present within either CTV3 or SNOMED CT, however there is a possibility of post-coordinated concept representations mapping onto LOINC concepts. SNOMED RT and Lab
LOINC have an agreement not to overlap, and this issue, while not an HL7 Version 3 issue
does need to be resolved for UK users.
8.2.2. DICOM
Digital Imaging Conformance (DICOM) (www.hl7.org/standards/dicom) evolved from
standards produced by a joint committee formed in 1983 by the American College of
Radiology (ACR) and the National Electrical Manufacturers Association (NEMA). DICOM
aims to:



Support communication of digital image information independent of device
Facilitate archiving systems
Be applicable to a networked environment
There are significant differences between HL7 and DICOM, indeed each was designed for
different applications. However there are areas of overlap such as diagnostic reports, and
efforts are underway within HL7 to promote interoperability between different image
management systems, and to ensure that the RIM has appropriate classes to support this.
DICOM is in use within the UK and the structure approximates to HL7 Version 2.x. Virtually
all digital image communications in the UK are DICOM compliant, and all new systems
within the last 5 years have been. Some manufacturers may have their own interpretation of
DICOM, (there are no use case profiles to which it is possible to comply) and as a result
inter- vendor connectivity is very difficult, but is possible if considerable care is taken.
DICOM are currently working with HL7 in the context of the Image Integration Special
Interest Group to their structured reporting methodology to introduce images into HL7
structured documents (CDA).
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8.3. Drug Terminology
The situation with respect to the representation of drugs messaging in Version 3 is the
subject of considerable ongoing debate within HL7 at present and can be described as ‘fluid’
at the time of writing.
One reason for the current debate is the need to ensure the Reference Information Model is
capable of representing the varying ways in which drugs can be expressed in messages.
These can be seen to lie on a spectrum from the atomic representation of generic concepts,
through to the specific representation of manufacturers’ products in particular pack sizes
(Figure 3).
Atomic
Representation
Specific
Representation
e.g.
e.g.
Atenolol; +
100mg; +
Oral;
Atenix 100mg Tablets
(Ashbourne
Pharmaceuticals) x28
Figure 3: Spectrum of Potential Drug Representation
Drug messaging will be managed through two elements working in combination; the
message structures (R-MIMS) which build the relationships between the components of the
RIM, and the registered vocabularies that provide the drug concepts to populate the
message. It is anticipated the contents of these vocabularies will be held in a ‘Medication
Master File’. However, as part of the ongoing debate there is currently some diverging
opinion over which elements of the message are required to be represented in the RIM and
which in the vocabulary.
One element of the Medication Master File which has been agreed in principle, although the
specific detail required to populate it is still being collated, relates to the representation of
standard dosage forms and routes of administration which will be recognised within the HL7
standard. Within the UK and Europe it will be necessary that HL7 recognises the ‘Standard
Terms, Pharmaceutical Dosage Forms, Routes of Administration and Containers’ which is
managed on behalf of the Council of Europe by the European Department for the Quality of
Medicines and The European Pharmacopoeia.
The impact of HL7 Version 3 on drug terminology within the NHS can be considered in six
areas:

A continuation of the ongoing positive input to the current development of drug
messaging standards through representatives of HL7-UK is required in order to ensure
HL7 Version 3 can support those use cases required specifically in the United Kingdom.

The structure of drug representation within SNOMED CT, as the NHS preferred clinical
terminology, will need to consider the messaging requirements of HL7 in order that any
necessary decomposition of drug concepts required to support messaging standards is
achievable from within the data provided by the terminology.
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
Any definition of drug concepts with respect to their dose form and route of
administration within SNOMED CT should ideally be consistent with the HL7 adopted
standard forms and routes.

It is a strategic necessity that SNOMED CT at its international core level, any UK specific
extension and the final format of the UK Standard Clinical Products Reference Source
must be fully integrated. This would be best achieved by the use of SNOMED CT
identifiers throughout, with the Reference Source concepts being hierarchically linked to
their terminological parents.

The hierarchy of SNOMED CT will need to consistently represent the types of concept
specified in HL7 as necessary components of some/all drug related messages.

Organisations involved in the procurement of systems intended to support drug and
appliance representations will need to consider the strategic requirement to support
messaging within the expected system lifetime when writing procurement specifications.
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9. Summary

HL7 has a momentum and uptake by suppliers world-wide, but particularly in the US,
that already makes it the world leading standard for clinical messages, at the very least
in secondary care. Other standards have not provided a “solution” of the scale of HL7.

Version 2 has a number of problems relating to the way it has evolved. Many, though not
all of these relate to the wide degree of optionality or interpretation permitted, an
approach that allowed the standard to be taken up, but which has generated problems in
later years. The HL7-UK Implementation guide should have a beneficial impact in this
problem in the UK.

Version 3 addresses these issues, and is likely to be a more generic approach but the
underlying RIM is not yet stable. The impact of ongoing development of messages on
the RIM has implications for the stability of the model.

The instability of the RIM, whilst a concern, also offers an opportunity for the NHS to
ensure its needs can be represented.

HL7 Version 3 signifies a big step change from Version 2 and there are no indications at
present when the RIM version 3 will be adopted and how successful its uptake will be.
Opinion amongst those consulted varies as to the timeframe for implementation, some
system suppliers are ready to implement in a limited environment while others believe it
will be 3 years or more.

There are a number of existing Version 2 users and vendors, predominantly in the
secondary care sector. It is unlikely to be productive to attempt to re-engineer all existing
messages as a first step, however new developments should be looking to Version 3.

Taking into account the NHS plans for widespread adoption of health information
systems, the NHS could become a major user of HL7, probably ranking alongside the
US Department of Defence and the US Healthcare Finance Administration (HCFA), the
funders of Medicare and Medicaid. This could be used as a negotiating lever with HL7 to
ask them to address any weaknesses and gaps identified in this report.

Any action taken by the NHS should also address the e-Government Interoperability
Framework version 2 (www.e-envoy.gov.uk/egovernment/egif2/intro.htm) which provides
the policies and standards for achieving interoperability across the public sector.
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10.
Next Steps
10.1.
Actions for the NHS

Given the likelihood of HL7 becoming a de-facto worldwide standard, The NHS needs to
decide at a strategic level whether to adopt HL7 as a standard and if so identify
appropriate timescales.

Most of he skills residing within the UK are currently outside the NHS, the NHS should
actively participate in ongoing development of Version 3 and look at how it can acquire
and develop the necessary skill mix.

The NHS has considerable experience, and has undertaken work in many areas covered
by HL7 Version 3. It is apparent that there are elements of the HcM within the RIM, and
concerns as to how these elements have been handled. It is important for this knowledge
to be fed into the HL7 process.

Implementation, including testing of Version 3 will require commitment of considerable
resources, along with effective stakeholder communication. This is consistent with
lessons learnt in previous NHSIA projects, and neglecting these aspects would be a
significant risk. The resource implications should therefore be assessed.

One way of addressing the scale of these resources set against the skills available to the
NHS and at the same time aligning with the modernisation and quality of care agenda
would be to break down larger work packages and to accelerate those associated with
key health conditions. For example with one or more of the major areas identified in the
NHS Plan – consideration should be given to how this might be achieved.

The HcM has had considerable investment, and is considered to have intellectual rigour
and integrity. However it does not appear to have had the impact on the marketplace of
HL7, and thus healthcare that one might have hoped. The NHS needs to learn from this,
both in this context, but also in other work areas within the NHSIA.
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10.2.
Risks of inaction by the NHS
Most observers agree that HL7 V3 is strategically correct (it is the only model that is subject
to a process of continual review and update). Failure to engage in the process could leave
the NHS disadvantaged in a number of ways:

Delay of adoption of any standard as part of a comprehensive clinical messaging
infrastructure to support the EHR approach

A need to implement international standards which do not fully support the needs of the
NHS

A shortage of appropriate knowledge and skills within the NHS

Considerable effort centred on producing and rolling out alternative messages of limited
value outside the NHS.

Inability to align NHSIA projects such as SNOMED Clinical Terms with international
standards
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Appendix A
Glossary
ACIG
Academy of Royal Colleges Information Group
ANSI
American National Standards Institute
ACR
American College of Radiologists
CAP
College of American Pathologists
CCOW
Clinical Context Object Workgroup
CEN
Committée Européan de Normalisation
CIS
Clinical Information System
CORBA
Common Object Broker Architecture
CTV3
Clinical Terms Version 3
EHR
Electronic Health Record
EN
Europäische Norm (European standard)
ENV
Europäische Vornorm (European pre-standard)
EPR
Electronic Patient Record
DICOM
Digital Imaging Conformance
DIM
Domain Information Model
ERDIP
Electronic Record Development and Implementation Programme
HcM
UK Health Care Model
ISO
International Standards Organisation
LOINC
Logical Observation Identifiers Names and Codes
LHSR
Left hand side of the RIM
MDF
Message Development Framework
MIM
Message Information Model
NEMA
National Electrical Manufacturers Association
OMG
Object Management Group
OSI
Open Systems Interconnection
RIM
Reference Information Model
RMIM
Refined Message Information Model
SIG
Special Interest Group
SNOMED RT SNOMED Reference Terminology
SNOMED CT SNOMED Clinical Terms
TC
Technical Committee
UML
Unified Modeling Language
XML
Extensible Markup Language
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Appendix B
Acknowledgments
This document has been reviewed, both internally within the NHSIA and externally. Thanks
are extended to the following people who have reviewed or contributed information.
NHSIA
Nigel Bell
Graham Folmer
Dr Colin Price
Dr David Jones
Peter Nicklin
Ian Soady
Andy Brown
John Willis
Chief Executive
Director, Programme and Service Delivery
Head of Delivery, Information for Personal Health
Head of Capability, Information Management
Senior Consultant
Senior Consultant
Project Manager, NHS Number for Babies
Senior Business Analyst, NHS Number for Babies
External
Dr Leo Fogarty
Professor Alan Rector
Dr David Markwell
Dr Peter Johnson
Ian Shepherd
Charlie Bishop
Melvin Reynolds
Ann Harding
Martin Whittaker
Dr Mike Robinson
Dr Dipak Kalra
ACIG, HL7-UK
University of Manchester, HL7-UK
Clinical Information Consultancy, HL7-UK
Newcastle University, HL7-UK
Royal Pharmaceutical Society
McKesson HBOC, HL7-UK
AMSC
iSOFT, HL7-UK
Touchstone Consultancy, STEP, HL7-UK
In Practice Solutions, HL7-UK
Centre for Health Informatics and Multi-professional Education
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Appendix C
one.
A comparison between the RIM version 0-100 and HcM version
RIM version 0-100 is a non-draft release that will be used to develop the initial set of HL7
Version 3 messages.
The model is divided in subject areas which each hold a collection of classes.6 Some subject
areas hold only a few classes and some of those classes are due to disappear from the
model in the near future. Although this further classification is not important in itself, it allows
for a quick overview and comparison to HcM.
Relevant Subject areas: Clinical documents, Healthcare service provider, Healthcare
Stakeholders, LHSR, Patient encounter, Patient service event, Patient service material,
Person, Scheduling. All other subject areas are or included in the relevant ones or related to
financial and insurance US specifics.
Comparison between HL7 classes and HcM classes7
Access
This class is a subtype of the class Role. The Access class has quite a few open issues
connected with it. Its description indicates that the class would map to the Subject class in
HcM, related to the Subject patient via an Inter subject relationship.
Attributes
Body_site_cd : subject characteristic type . HL7 provides a limited, coded set of anatomical
target sites for an Access, which HcM would list here as instances of the class Subject
Characteristic Type. Recorded for a specific access: Category Subject Characteristic of type
body site.
Entry_site_cd : subject characteristic type. The HL7 coding set is identical to the above.
Recorded for a specific access: Category subject characteristic of type entry site.
Gauge_qty : subject characteristic type. Recorded for a specific access: measured subject
characteristic of type gauge. Units are defined in the Unified Code for Units of measure, Unit
of Measure in HcM.
Act
Terms such as Action, Activity, Service or Service Action are used as synonyms. Act is
defined as an intentional action in the business domain of HL7. As such it corresponds to
Activity in HcM.
Composition
Originates_ in_context_of 1,1 Act_context : corresponds to Activity in Context in HcM.
Note however that the cardinality on this composition of HL7 suggests that an Act is always
an activity in context which is not correct. The Act_context class adds very little information
to the activity and is an open issue.
6
7
In the text the terms ‘subject areas’ and ‘classes’ appear to be used interchangeably.
References to HcM are in italic.
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Associations
Is_source_for 0..n Act_relationship : see under class Act_relationship
Is_target_for 0..n Act_relationship :see under class Act_relationship
Has
0..n Participation : see under class Participation
Attributes
Activity_time: completion timepoint association to State Change Activity.
Availability_dttm: would be recorded as an Activity Qualifier
Confidentiality_cd: code that limits disclosure of information about the service. In HcM
covered by the association of Access Group for Object to Object which will include Activity.
This association will also allow the specification of a level of confidentiality for the total of the
patient record which is not covered by this HL7 proposal. 8
Critical_time: This attribute has a different interpretation for activities in different moods and
for some of the subtypes of Act. This attribute is needed in HL7 because there is no
separation between the action and its results. In HcM actions can be separated from the
subject characteristics that they observe. Subject characteristics carry their own time points.
Additional time points that relate to the activity will be recorded as Activity Qualifiers.
Id: identifier attribute of Object in HcM.
Interruptible_ind : record as Activity Qualifier.
Max_repeat_nmr: In HcM if an activity is to be repeated it is recorded as a Repetitive
Activity. This attribute would be an Activity qualifier of a repetitive activity.
Mood_cd: corresponds to some of the Activity states in HcM. It is not totally clear from the
document which moods are used, whether they are the same as in the USAM model or if
changes have been made since the last version of that model and some additional moods
have been added here such as trigger mood.
Event mood: Completed Activity
Definition mood: Activity Type
Order mood: this could refer to Activity to be done, Performer selected activity,
Scheduled activity
Goal mood: Target property
Trigger mood: no mapping.
Orderable_ind: Activity Qualifier
Priority_cd: Urgency association to Activity.
Txt: Activity Qualifier
Type_cd: Activity Type that may or may not be coded.
Status_cd: is intended to cover activity states.
Aborted: Abandoned Activity
Active: could map to several activity states in HcM for instance Started Activity
Cancelled: Not required Activity
Completed: Completed activity
Held: could refer to Activity under consideration, Performer suspended, Performance
suspended
New: has no meaning as a state of an activity.
Superseded: Activity Substitution
Suspended: could be Performance suspended activity or Performer suspended
activity
The RIM document does not provide a full description of the moods and states of an Act but
it refers to the USAM model. What follows is from USAM version 2.6
States of action are a strictly defined code set, no exceptions allowed.
8
HL7 propose a code set from which the user will need to choose. This may not align with
confidentiality policies used by institutions in the UK
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The state transition model is uniform through all moods.
Definition mood
The states for this mood suggests some tips for the maintenance of the knowledge level in
HcM. Relates basically to the state of the Activity Type instance in the knowledge level.
New: service definition is in committee status, ie it is authored and may change before it can
be instantiated. No mapping to HcM
Cancelled: service definition has been abandoned before activation. No mapping.
Held: rarely used. No mapping.
Active; can be instantiated. Activity type instance
Aborted: definition was wrong and is withdrawn. No mapping.
Suspended: may be resumed later. No mapping.
Completed: definition is retired, no longer used. No mapping.
Superseded: service definition superseded by a new definition. New Activity Type.
Intent mood
New: service is being considered, Activity under consideration
Cancelled: service was considered but now abandoned, Not required Activity
Held: rarely used. No mapping.
Active: service intent is committed to (on TODO list), Activity to be done
Aborted: service intent is abandoned, Abandoned Activity
Suspended: active intent suspended, Performance suspended Activity or Performer
Suspended Activity
Completed: intent is completed if the intended action has been performed (ripple effect of
completion of the service event) Completed Activity
Superseded: intent is completed but the record of intent was corrected. No mapping.
Order mood
New: order is being authored or is waiting to be issued. The filler does not yet know about it.
Activity under consideration
Cancelled: abandoned by placer before issued. Not required Activity
Held: order is held before issued. No mapping
Active: order has been issued, Activity to be done
Aborted: Abandoned Activity
Suspended: Performance suspended Activity
Completed: as intent, only completed when event is completed, Completed Activity
Superseded: order is amended after it was completed. No mapping.
Event mood
New: service is in preparation, waiting to be activated, Activity under consideration
Cancelled: abandoned before activated Not required Activity
Held: event on hold Activity under consideration
Active: service event currently in progress Started Activity
Aborted: Abandoned Activity
Suspended: Performance suspended Activity
Completed: Completed Activity
Superseded: completed but superseded. In HcM the completed state is the final state of an
activity.
Predicate mood
Active: main state, predicates only evaluated when active. No mapping.
Aborted: active service is exceptionally terminated. No mapping.
Suspended: a suspended predicate will not be evaluated. No mapping.
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Goal (i.e. predicate used as a goal)
New: goal is being considered. Intention under consideration
Cancelled: goal was abandoned before it was set, Abandoned intention
Active: actively pursued goal, Established Focus
Aborted: dismissed as being unachievable, Rejected Focus
Completed: goal has been achieved Fulfilled intention
Note here that the goal mood refers to a Subject Property which will be the goal.
Activity states in HcM not covered by this proposal: scheduled activity, performer accepted
activity, performer selected activity, performer rejected activity, performance rejected activity.
Act_context
This class is a subtype of Act. This class has open issues such as the implication of the
implied inheritance from Act. This class is equivalent to Activity in context.
Composition
Originates_in_context_of
Context Activity
1,1 Act = context association between Activity In Context and
Attributes
Level_cd: Is an open issue. Would be activity qualifier in HcM.
Act_relationship
This is a recursive associative class with a source association to Act and a target association
to Act. Relationships between acts are explicitly expressed in HcM and some of the
relationships in this class are covered by relationships between subject characteristics in
HcM.
Associations
Has_source 1,1 Act : no mapping
Has_target 1,1 Act: no mapping
Attributes
Checkpoint_cd: codes that indicate when associated pre-conditions are to be tested. No
mapping to HcM.
Conjunction_cd: no mapping
Inversion_ind: reverses meaning of the relationship type. Needed because of fixed
attribution of attribute to source of relationship. Not needed in HcM.
Join_cd: codes that indicate how concurrent activities are synchronised. No mapping.
Negation_ind: no mapping
Pause_qty: no mapping.
Priority_nbr: no mapping
Sequence_nbr: no mapping
Split_cd: no mapping
Type_cd: indicates the meaning of the relationship. This is the most important attribute
besides mood_cd, it is a structural attribute in that each of its values implies specific
constraints to what kinds of acts can be related and in which way.
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The document refers to the USAM. (No version indicated)
Act relationship types
Has component: parent/component association between Activities
Has specialisation : categorical knowledge about services – relation between Activity Types
in HcM, genus-species link with Category
Has pre-condition: this link restricts the target activity to be in pre-condition criterion mood :
Activity Qualifier
Has trigger: the target activity must be in pre-condition trigger mood. A delay
between the actions can be specified . Activity Qualifier and further qualifier of that
qualifier.
Has reason: the reason will be another activity. In HcM, Reason is a class (not an
Activity) associated with Activities in certain states: abandoned, rejected, not
required. For activities in other states you could use Activity Qualifier.
Suggests: inversion of above.
Has contra indication: target service in criterion mood. Activity Qualifier which could
be further qualified with the strength of the contra indication.
Has outcome: target must be an observation, source is condition node or action (Note that
condition node is not present in the RIM !): Property qualifiers, Outcome of Property or
Outcome of Activity
Has goal: target must be observation in goal mood. Target Property
Has final objective: target must be observation in criterion mood (desired outcome).
Target Property
Has continuing objective: target must be observation in criterion mood (desired state
to be maintained) Target Property
Has risk: noteworthy undesired outcome Activity qualifier
Has pertinent information : very unspecific relationship from one item of clinical information
to another
Has support: source must be observation: Subject Property Qualifier or a more
specific association such as Subject Property has as basis Basis for Hypothesis
Has explanation: reverse of above
Is cause for: Causal relation
Is manifestation of: reverse of above Causal relation
Is derived from: both target and source are observations: source association between
Subject Properties
Has reference values: target in criterion mood. Use the genus-species in the
knowledge level to associate a Subject Property Type with reference values.
Assigns name: source is a condition node. Condition node is not a class in RIM.
Is revision of: would be an Activity Qualifier
Amends: used in the sense of amending reported results. No mapping.
Updates (condition): used here for updates to condition nodes which are not present
in the RIM
Instantiates: maps to link between Activity and Activity Type
Fulfills (order): state link between Completed activity and an Activity To be done or
Scheduled Activity or Started Activity.
Dispensing for (order): links between activities of type drug therapy and type drug
administration
Substitutes (brand product): link between the two activities through their state
Matches (trigger): links actual service with service in criterion mood. Link between
activities in different state
Evaluates: the observation evaluates the goal link between Target Property and
Actual Property
Has option: source is in mood definition, intent or order. Activity Qualifier
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Billing_information_item
Subtype of Unmapped_financial_classes
This class is not relevant for the NHS at this point in time.
Champus coverage
Subtype of Healthcare_benefit_product_policy, itself subtype of Financial_act.
This class is not relevant for the NHS at this point in time.
Clinical document
This class is due to be deleted from the RIM and is to be incorporated within the Act class
and/or a high level meta-model. 9
Associations
Contains 1,1 clinical_document_body: clinical_document_body would be a subject
characteristic of Subject Clinical Document.
Attributes
Confidentiality_cd: as Act. Access Group For Object in HcM
Language_cd: Subject Characteristic
Local_id: Identifier in Domain in HcM
Originator: ‘performer’ association with Agent
Clinical document header
This class is a subtype of Entity and is due to be deleted from the RIM. Its functionality will
be integrated with the Act class. View as Subject. 10
Attributes
Availability_status_cd: this attribute is an open issue as no examples of codes for this
attribute exist. This attribute would be a Category Subject Characteristic of type availability in
HcM.
Change_reason_cd: Category Subject Characteristic of type change reason
Completion_status_cd: (Open issue), Category Subject Characteristic of type completion
status.
Confidentiality_status_cd: Access Group for Object association with Object
Content_presentation_cd: (Open issue), Category Subject Characteristic of type content
presentation
Document_change_cd: Category Subject Characteristic of type document change
Document_creation_dttm: Timepoint valued Subject Characteristic of type document
creation
9
The idea of information containers separate from information is suggested. From that perspective
the clinical document could be seen as a Subject in HcM with specific characteristics.
10 If integration with Act goes ahead then the document will be viewed as a container for information
about the service/activity.
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File_nm : Text valued Subject Characteristic of type file name
Last_edit_dttm: Timepoint valued Subject Characteristic of type of type last edit
Reporting_priority_cd: (Open issue) Category valued Subject Characteristic of type reporting
priority
Results_ report_dttm: start timepoint association with subject characteristics which are the
results.
Storage-status_cd: Category valued Subject Characteristic of type storage status
Transcription_dttm: Timepoint valued Subject Characteristic of type transcription
Version_dttm: Timepoint valued Subject Characteristic of type version
Version_nbr: (Open issue), replace with unique identifier for a document. Subject Identifier.
Consent
This class is a subtype of Act with no specific attributes or additional associations.
This maps to the class Subject responsibility Act in HcM. Subject Responsibility Act is also a
subtype of Activity but has mandatory link to a Subject Responsibility which is the result of
the act.
Container
This class is a subtype of Manufactured_material, which itself is a subtype of Material which
itself is a subtype of Entity. From that perspective Container would be viewed as a Subject
and its attributes as Subject Characteristics.
The attributes described for the class Container come from NCCLS it is unclear they
represent.
Device
This class is another subtype of Manufactured_material.
Again the Device can be considered to be a Subject in HcM.
Attributes
Alert_level_cd: Category Subject Characteristic
Last_calibration_dttm: Timepoint valued Subject Characteristic
Local_remote_control_state_cd: Category Subject Characteristic
Manufacured_model_nm: Text valued Subject Characteristic
Software_nm: Text valued Subject Characteristic
Diagnostic_related_group_definition
This class is a subtype of Financial_act and is associated with Encounter_drg.
The NHS uses HRGs, closely related to DRGs.
Diet
This class is a subtype of Supply, itself a subtype of Act.
Compares to HcM with an Activity of Activity Type Diet.
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Attributes
Carbohydrate_qty: Measured Activity Qualifier
Energy_qty: Measured Activity Qualifier
One would expect that additional qualifiers or attributes would be needed for an Activity of
type Diet such as for instance saturated/ unsaturated fat content of a diet, vitamins, minerals,
etc.
Document_service
This class is defined a subtype of Act and would be an Activity of Activity Type document
service.
Most of the attributes specified for this class seem to relate to the document produced and
not to the activity of document service (storage is a clear example of this). In HcM the
document would be viewed as a Subject and the attributes defined here would be Subject
Characteristics of the document as a Subject.
Attributes
Completion_cd: attribute may be deleted due to overlap with Act, Activity Qualifier of type
completion.
Copy_dttm: Activity qualifier of type copy (release_date)
Origination _dttm: Activity qualifier of type origination
Set_id: Activity qualifier of type set.
Storage_cd: Activity qualifier of type storage
Version_nbr: Activity qualifier of type version
Employee_employer
This class is a subtype of Role_relationship which is associated to Role.
Would call this in HcM an Authorised Agent (employee) who is associated with another
Agent (employer) which is given the Authorised agent authority.
Attributes
Addr: Authorised Agent at some specified (association) Location
Hazard_exposure_txt: no mapping
Job_cd: Authorised Agent Activity of type Activity Type
Job_class_cd: no mapping 11
Job_title_nm: no mapping
Protective_equipment_txt: no mapping
Salary_qty: no mapping
Salary_type: no mapping
Status_cd: Agent State for Authorised Agent
Telecom: no mapping12
11
The description of the job holds a job code, a job class (full time, part time), a job title. These
attributes e would be further qualifiers of the Authorised Agent Activity but this is not possible in the
current HcM .
12 The attributes for which no mapping is indicated point to changes required in HcM
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Encounter_drg
This class seems very specific to the US but as mentioned before DRGs are in use in the
NHS. There is however no link between this class and the Patient_encounter class to which
it must relate.
Encounter_facility_association
This class refers to the association between a Patient encounter and a Healthcare Facility
and is an open issue. The class maps to two different constructs in HcM. Activities in certain
states (started, scheduled, to be done, performer accepted and completed) will be
associated with a Location. The HcM also has a class Subject Location which represents the
association between a Subject and a Location which will have a timeperiod associated with it
and can be further qualified.
Associations
Is_sited_at 1,1 Healthcare Facility: location_for Subject Location 13
Is_used_by 1,1 Patient_encounter: refers to the Activities for Subject and where they take
place, which is the association of the Activity in certain states to a Location.
Attributes
Effective_tmr: Timepoint association with Subject Location
Status_cd: (Open issue) the meaning of this attribute is not clear.
Transfer_reason_cd: Category Subject Property Qualifier (of the Subject Location)
Entity
The closest mapping to HcM would be to Subject.
Associations
Has
0..n Entity_name : Subject has 0..n Subject Name
Sends 0..n Message : not represented as an association for Subject but would be an
association for Agent
Shall_receive 0..n
Message : not association for subject but would be an association for
Agent
Plays_a_role 0..n
Role : Subject has role 0..n Agent
Attributes
Desc: Text valued Subject Characteristic of Subject
Determiner_cd: (Open issue) unclear description of attribute
Id: Identifier association with Object
Importance_status_txt: (Open issue) Text valued Subject Characteristic
Qty: Measured Subject Characteristic 14
Status_cd: (Open issue) state as in state transition. Subject has no state in HcM and a state
attribute would not be relevant to all instantiations of Subject.
This construct makes it difficult to record a patient encounter at the patient’s home since that would
need to be a health care facility.
14 This could be added to HcM as an attribute of Subject.
13
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Telecom : Subject Contact association with Subject
Type_cd: (Open issue) main classifying attribute. No subject type is used in HcM, as it is not
envisaged that extra classes or associations will be needed.
Entity name
Would be mapped to HcM as Subject Name.
Associations
Is_for 1..1 Entity: subject
1..1
Subject
Attributes
Effective_tmr: start/end association of Timepoint with Subject characteristic
Nm: name attribute of Subject Name
Purpose_cd: Preferred name for Subject related to Agent
Financial Act
This class is a subtype of Act and is at present not applicable to the NHS.
All defined attributes for this class would be covered through Activity class in HcM.
Financial transaction
This class is a subtype of Financial Act and is related to a patient billing account and as such
not applicable to the NHS.
Guarantor_contract
This class is a subtype of Unmapped_financial_classes and seems specific to the US
situation.
Health_chart
This class is a subtype of Entity and is referring to an individual patient record. In the HcM no
subtypes of Subject are defined, so Subject should cover the Health Chart class.
Associations
Has_an_assessment_of
0..n
health_chart_deficiency : it is not clear what a
deficiency is and if that in effect is a characteristic of the patient rather than of the health
chart. The HcM has a class Object Representation which can be used to represent
information about any Object in a Subject. The Health chart as Subject will hold information
about another Subject, the patient.
It is unclear how the health chart is related to the patient since no associations are possible
between entities only between roles.
There is no relationship between this class and clinical document.
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Health chart deficiency
This class can only be mapped as Subject characteristic of type Health chart deficiency. The
subject here is the patient.
Associations
Is_assessed_against 1..1
Health_chart: see above comments.
Attributes
Assessment_dttm: Timepoint association with Subject Property
Desc: Text valued Subject Property Qualifier
Level_cd: Category Subject Property Qualifier
Type_cd: Category Subject Characteristic of type health chart deficiency
Healthcare_benefit_coverage_item
This class is a subtype of Financial_act and specific to US circumstances.
Healthcare_benefit_product_ policy
This class is a subtype of Financial_act and specific to US circumstances.
Healthcare_facility
This class is a subtype of Place, itself a subtype of Entity
(Open issue) admit insufficient definition which makes it difficult to determine what is meant.
As a subtype of Entity it would map to Subject, when it is used in the context of patient
encounters it maps as Location.
Associations (relevant for Location)
Is_site_for
states)
0..n
encounter_facility_association : location for 0..n
Activity (in some
Attributes (relevant for Subject)
Licensed_bed_nmr: Subject Characteristic of Healthcare_facility as Subject.
Mobile_ind: Subject Characteristic of Healthcare_facility as Subject.
Healthcare_provider
This class is a Subtype of Role and would be described as an Agent in HcM.
Attributes
Speciality_cd: (Open issue) because it is felt this attribute should be moved to
Individual_healthcare_practitioner: Would be a Subject Characteristic of the Subject linked to
the Agent.
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Individual_healthcare_practitioner
This class is a Subtype of Healthcare_provider and will map as the above to Agent in HcM.
The attributes specified for this class are specific to US certificates. They would be Subject
Characteristics of the Subject which has role of the Agent.
Inpatient_encounter
This class is a subtype of Patient_encounter. It would be viewed as an Activity of type
Patient encounter.
Attributes
Length_of_stay_qty : Activity Qualifier for the Activity
Insurance certification
This class is a subtype of Unmapped_financial_classes and specific to US circumstances.
Language ability
This class would be considered in HcM as a Subject Property Qualifier of type language
ability which qualifies Person Language as a Subject Characteristic for the Subject patient.
Associations
Specifies_ability_in
1,1
Person_language: qualifies
1,1 Subject Characteristic
Attributes
Mode_cd: Category Subject Property Qualifier of Subject Characteristic of type
person_language (this is an additional qualifier of Person_language)
Proficiency_level_cd: Category Subject Property Qualifier of Mode_cd. Qualifiers can
themselves be further qualified which is the case here.
Living_subject
This class is a subtype of Entity and maps to Subject in HcM.
Attributes
Administrative_gender_cd: Subject Characteristic
Birth_dttm: Subject Characteristic
Deceased_dttm: Subject Characteristic
Deceased_ind: Subject Characteristic
Multiple_birth_ind: Subject Characteristic
Organ_donor_ind: Subject Characteristic
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Manufactured material
This class is a subtype of Material, itself a subtype of Entity.
This would again refer to the view of resources/material as a Subject
Attributes
Expiration_dttm: (Open issue) Subject Characteristic
Lot_nbr: Subject Characteristic
Material
This class is a subtype of Entity and maps to Subject in HcM.
Attributes
Danger_cd: Subject Characteristic of type Danger/hazard
Effective_tmr: Subject Characteristic of type effective_time
Form_cd: Subject Characteristic of type form
Handling_cd: Subject Characteristic of type handling
Medication
This class is a subtype of Act and would map to Activity. Medication is not seen as a
separate activity in HcM and the material used is described as Qualifiers of the activity or
included in the Activity Type description of the medication activity.
Attributes
Body_site_cd: Activity Qualifier of type body_site
Dose_check_qty: Activity Qualifier of type dose check
Dose_qty: Activity Qualifier of type dose
Form_cd: Activity Qualifier of type form
Method_cd: Activity Qualifier of type method
Rate_qty: Activity Qualifier of type rate 15
Route_cd: Activity Qualifier of type route
Strength_qty: Activity Qualifier of type strength. 16
Substitution_cd: Activity Substitution
Military Person
This class has open issues on most attributes and needs a description.
This class will be mapped to Subject in HcM.
15
Dose_qty and rate_qty must be both used to express 100mL/h where 100mL = dose_qty and 1h =
rate_qty.
16 HL7 is discouraging use of this attribute, dose specification is usually sufficient and if specific
preparation is dispensed then the Material class is used.
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Attributes
Military_branch_of_service_cd: Subject Characteristic of type military branch of service
Military_rank_nm: Subject Characteristic of type military rank
Military_status_cd: Subject Characteristic of type military status
Non_Person_living_subject
This class is a subtype of Living_subject and will map again to Subject in HcM
Attributes
Breed_cd: Category Subject Characteristic of type breed
Euthanasia_ind: Category Subject Characteristic of type euthanasia
Gender_status_cd: Category Subject Characteristic of type gender status
Production_class_cd: Category Subject Characteristic of type production class
Strain_txt: Text valued Subject Characteristic of type strain
Taxonomic_classification_cd: Category Subject Characteristic of type taxonomic
classification
HL7 has fixed set of attributes for this class. This may not cover all characteristics that are
important to record about a Non_Person_living_subject.
Notary public
This class is a subtype of Role and will map to an Authorised Agent in HcM.
Attributes
Notary_county_cd: specific to US. Would be a Location attached to the Authorised Agent
Notary_state_cd: specific to US. Would be a Location attached to the Authorised Agent
Observation
This class is a subtype of Act. Activity in HcM covers the activity of observation.
Attributes
Body_site_cd: Activity Qualifier of type body_site
Derivation_expr: this refers to the result of the observation which is separately handled in
HcM. This attribute could be expressed as a Subject Property Qualifier of the subject
characteristic observed.
Interpretation_cd: again this attribute refers to the result/outcome of the observation which
are Subject Characteristics in HcM. If a coded classification existed to roughly interpret
subject characteristics then this would be a Subject Property Qualifier of the subject
characteristic observed during the observation
Method_cd: Activity Qualifier of type method
Value: Subject Properties observed by the activity
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Organisation
This class is subtype of Entity and will be Subject in HcM.
Attributes
Addr: Subject Location linked to Location
Org_nm: Subject Name
Standard_industry_class_cd: Subject Characteristic of type standard industry class
Outbreak
This class is a subtype of Public_health_case itself a subtype of Observation.
This conflicts with the definition of Act (its supertype) as an intentional action. An outbreak is
not intentional.
HcM has a class Event which is the supertype of Activity and Incident.
Attributes
Tmr: start and end associations from Timepoint to Incident.
Participation
There is no equivalent class in HcM. The construct refers to Authorised Agent classes in
HcM and the functionality implied by its associations to Activity.
Associations
For
1..1
Act: Agents associated with Activities
Has_as_participant 0..1
Role: Authorised agents associated with Activities
Attributes
Awareness_cd: only for person targets. Would be a Subject Characteristic of the Subject
(patient)
Encounter_accommodation_cd: (Open issue) Maps to Subject location.
Function_cd: 17 Activities must be decomposed so the activity type indicates the function
performed by the role.
Note_txt: comment attribute on Object
Signature_cd: 18 could be viewed as a Qualifier of the Activity
Signature_txt: could be viewed as a Qualifier of the Activity
Status_cd: covered by states of activity related to agents such as performer
selected/rejected/suspended
Tmr: time points on the decomposed activities
Type_cd: activities must be decomposed to the level that individual agents are related to it
17
The text refers to Actors, which are a class in USAM but not in this RIM. There is no facility in HcM
to indicate the particular role an agent had in an activity other than those outlined in existing
associations with activity.
18 This also points towards Subject Responsibility.
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Patient billing account
This class is a subtype of financial act and not relevant to the NHS at this point in time.
Patient_encounter
This class is a subtype of Act and would be an Activity in HcM
Associations
Uses o..n
Encounter_facility_association : refers to location link to Activity
Is_authorised_by
0..1
Preauthorisation: related to finance. No equivalent in NHS
Utilises 0..n
Transportation : (Open issue) the activity of transportation would form part of
the overall Activity of type patient encounter
Attributes
Acuity_level_cd: (Open issue) Activity qualifier of type acuity
Birth_encounter_ind: indicates if person is new-born baby. This could be mapped to Activity
Qualifier
Classification_cd: Activity type of the Activity
Discharge_desposition_cd: Subject Characteristic observed by the Activity of type discharge
Effective_tmr: start/end timepoint associations with Activity
Encounter_classification_cd: Activity type of the activity or a further Activity Qualifier
Practice_setting_cd: Location for the Activity
Pre_admit_test_ind: Activity Qualifier
Source_cd: Activity Qualifier
Special_courtesies_cd: Activity Qualifier
Status_reason_cd: (Open issue) Activity Qualifier of the State change Activity
Valuables_desc: Subject Characteristic
Valuables_location_desc: Qualifier of the Subject Characteristic of type valuables
Patient _Provider
This class is a subtype of Role_relationship and would refer to Subject Responsibility in HcM
Attributes
Confidentiality_constraint_cd: this attribute relates to the person (Subject) so would be a
Subject Characteristic.
Preferred_pharmacy_id: (Open issue) could call this a Subject Responsibility of type
preferred pharmacy
Status_cd: state attribute of Subject Responsibility
Very_important_person_cd: Subject Characteristic
Person
This class is a subtype of Living_subject and has some open issues.
Would map to Subject in HcM
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Associations
Communicates_in
language
0..n
Person Language : Subject Characteristic of type Person
Attributes
Addr: Subject Location
Ambulatory_status_cd: (Open issue) Subject Characteristic of type ambulatory status
Birth_order_nbr: Subject Characteristic of type birth order
Credit_rating_cd: Subject Characteristic of type credit rating
Disability_cd: Subject Characteristic of type disability
Education_level: (Open issue) Subject Characteristic of type education level
Ethnic_group_cd: Subject Characteristic of type ethnic group
Living_arrangement_cd: (Open issue) Subject Characteristic of type living arrangement
Marital_status_cd: (Open issue) Subject Characteristic of type marital status
Race_cd: (Open issue) Subject Characteristic of type race
Religious_affiliation: (Open issue) Subject Characteristic of type religious affiliation
Special_accommodation_cd: (Open issue) Subject Characteristic of type special
accommodation
Student_cd: Subject Characteristic of type student
Person language
(Open issue) Would be a Subject Characteristic of type person language in HcM
Associations
Is specified_by
0..n
Is_communicated_by 1..1
Language_ability : qualified by 0..n Subject Property Qualifier
Person: subject 1..1 Subject
Attributes
Cd: Identifier associated with Object
Preference_cd: Subject Property Qualifier of type preference
Place
This class is a subtype of Entity and as such relates to Subject.
Attributes
Addr: Location
Directions_txt: Subject Characteristic of type directions
Gps_txt: (Open issue) specific US
Position_txt: Subject Characteristic of type position
Practitioner_Certifier
This class is a subtype of Role_ relationship and maps to Authorised Agent in HcM
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Attributes
Board_certification_type_cd: could be seen as the Activity types related to the Authorised
Agent
Certification_dttm: Timepoint start association with Authorised Agent
Recertification_dttm: Timepoint end association with Authorised Agent
Residency_field_cd: (Open issue) Location for the Authorised Agent
Practitioner provider
This class is a subtype of Role_relationship and as such another Authorised Agent
Attributes
Position_cd: no definition for this attribute
Primary_care_ind: would be included in the description / associations of the Authorised
Agent
Preauthorisation
This class is a subtype of Unmapped_financial_classes and is related to financial
authorisation before patient services are delivered. Therefore it is not applicable to the NHS.
Procedure
This class is a subtype of Act and would be covered under Activity in HcM
Attributes
Body_site_cd: Activity Qualifier of type procedure body_site
Entry_site_cd: Activity Qualifier of type procedure entry_site
Method_cd: Activity Qualifier of type procedure method
Public health case
This class is a subtype of Observation but could best be seen as an Incident of type Public
health case.
Attributes
Detection_method_cd: (Open issue). An Incident in itself in HcM cannot be qualified, would
need to be a Qualifier of Involvement in incident which relates to one Subject.19
Disease_imported_cd: Qualifier of Involvement in Incident for one Subject
Transmission_mode_cd: (Open issue) Qualifier of Involvement in Incident
Referral
This class is a subtype of Act and relates to Activity in HcM
19
This Subject may be a defined population
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Attributes
Authorised_visits_qty: (Open issue) Activity Qualifier
Desc: (Open issue) Activity Qualifier
Reason_text: (Open issue) Activity Qualifier
Resource slot
Would correspond to Temporal Resource Act in HcM.
Associations
Is_managed_by
1,1
Schedule: decomposition of Activities
Attributes
Status_cd: Activity State
Time_slot: Timepoint associations with Activity
Role
This class maps to Authorised Agent in HcM
Associations
Is_played_by 1..1
Participates_in
Is_source_of
Is_target_for 0..n
Entity: Agent 1..1 subject association with Subject
0..n
Participation: Agent 0..n
associations with Activity
0..n
Role_relationship: no mapping
Role_relationship: no mapping
Attributes
Addr: Location association with the Authorised Agent
Effective_tmr: timepoint association with the Authorised Agent
Telecom: can only be recorded on the subject as subject contact.
Type_cd: HcM has no types for authorised agent, the details lie in associations to Subject
Characteristic Type and Authorised Agent Activity
Role_relationship
Relates again to Authorised agent but also to Inter Subject Relationship. In HcM Authorised
Agents can only be linked together by creating another Authorised Agent .
Associations
Has_as_source
Has_as_target 1..1
Has_parts
0..n
Is_part_of
0..1
1..1
Role: no mapping
Role: no mapping
Role_relationship :no mapping
Role_relationship: no mapping
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Attributes
Certificate_txt: no mapping
Effective_tmr: Timepoint association to Authorised Agent
Id: cannot quite see the relevance of this attribute which is referring to material. Identifier
association with Object takes care of any additional identifiers.
Position_nbr: limited to associations between entities where position is important. In that
case this would refer to Inter subject relationship between Subjects which can be qualified
with Subject Property Qualifier of type position
Qty: how much of the target material is held in source material of a relationship, Subject
Property Qualifier.
Responsibility_cd: Access Group for Object
Status_cd: (Open issue) depends on states possible.
Type_cd: codes include codes for Inter subject relationships, Agents, and Authorised
Agents.
Schedule
This class is a subtype of Role_relationship and would map to Temporal Resource Act in
HcM.
Associations
Manages
0..n
Resource_slot: parent/component association between Activities
Attributes
Slot_size_increment_qty: quantity attribute of Activity
Status_cd: Activity State
Specimen
This class is a subtype of Role and would be viewed as a Subject in HcM.
Attributes
Body_site_cd: Subject Characteristic of type body_site
Supply
This class is a subtype of Act and maps to Activity in HcM
Attributes
Quantity: quantity attribute of Activity
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Transportation
This class is a subtype of Act and maps to Activity in HcM
Associations
Is_utilised_during
parent/ component
1..1
Patient_encounter: activities are linked with each other as
Unmapped financial classes
(Open issue) Not relevant to NHS
Working list
This class is a subtype of Act and an (Open issue). It would map to Activity in HcM.
Attributes
Ownership_level_cd: Access Group for Object
In addition to the above classes there are also a set of Infrastructure classes and Data Type
classes.
Infrastructure classes
These classes seem to be specific to the sending of messages/queries and the retrieval of
structured information from tables. Important is where these classes link to the above
classes.
Message (Infrastructure) is associated with Entity (sender/recipient): message would be
related to an Agent
Message interaction is subtype of Act_context : no mapping
Clinical_document_body is contained in Clinical_document and contains 1..n Structure.
: these classes are under revision.
HL7 Impact Assessment v1.0 March 2001
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