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[pic] |EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITè EUROPèEN DE NORMALISATION
EUROPäISCHES KOMITEE FýR NORMUNG |CEN/TC 251/02-005
2002-02-26 | |


|CEN/TC 251 |
|Health Informatics |
|Secretariat: SIS |





|TITLE/ |CEN/TC 251 Task Force 13606: |
|SUBJECT: |Electronic Health Record Communication |
| |Proposed Scope and Technical Approach |
| | |
|SOURCE: |Dipak Kalra |
| | |
|ACTION |For comments |
|REQUIRED: | |














CEN TC/251 Task Force 13606:
Electronic Health Record Communication

Proposed Scope and Technical Approach


This document presents the scope of the new CEN TC/251 EHRcom Task Force,
and outlines the key Tasks that comprise its technical approach. The
facilities proposed to support Task e-working are also described. The draft
letter to invite input from industrial and other parties is appended with
two accompanying annexes. Feedback is welcome on this proposal; please send
an e-mail to d.kalra@chime.ucl.ac.uk.


1 Background

In December 2001 CEN TC/251 confirmed a new Task Force, EHRcom, to review
and revise the four-part pre-standard ENV 13606 relating to Electronic
Healthcare Record Communications.



ENV 13606: Electronic Healthcare Record Communication (1999)

Part 1: Extended Architecture
Part 2: Domain Termlist
Part 3: Distribution Rules
Part 4: Messages for the Exchange of Information


ENV 13606 was originally published in 1999 and, as with all pre-standards,
intended for review and potential revision after three years. It is hoped
that the result of such revision now by the Task Force can lead to a
definitive standard (EN).

The timetable proposed for the EHRcom Task Force is shown below.

May 2002: INitial Report (INR)
Jan 2003: First Working Draft (FWD)
Jul2003: consolidated response to ENQuiries (ENQ)
Jan 2004: final draft For Formal Voting (FFV)

No funding has been made available to the Task Force.

Working Group 1 elected Dr Dipak Kalra from University College London, UK,
the EHRcom Task Force Leader in February 2002. He is now in the process of
confirming the principal participants and the initial work plan, as
outlined in this document. The final version of this scope and technical
approach document will be incorporated within the INR to be published in
May 2002 for consideration by CEN in June 2002 (at the next TC/251 meeting
in Madrid).


1 Scope of the new standard

The overall goal of the EHR communications standard proposed by the Task
Force is:

to produce a rigorous and durable information architecture for
representing the EHR, in order to support the interoperability of
systems and components that need to interact with EHR services:
. as discrete systems or as middleware components;
. to access, transfer, add or modify health record entries;
. via electronic messages or distributed objects;
. preserving the original clinical meaning intended by the author;
. reflecting the confidentiality of that data as intended by the
author and patient.


A more detailed description of the Task Force scope was published in N01-
044 as the new Work Item proposal (Klein G, Freriks G. Health informatics -
Electronic health record communication: revision of ENV 13606:1999 to a
full European Standard. December 2001.)

This work item consists of the revision of the four part standard ENV
13606 to a full European standard (EN).

The general scope of this standard is to provide a definition of the
essential elements to support the interoperability of software
components or record systems providing or requiring access to
electronic health record (EHR) data. The subject of the record or
record extract to be communicated is an individual person, and the
scope of the communication is predominantly with respect to that
person's care. However, the possibility of providing guidance or
extension to the use of the record architecture for such circumstances
where one record for a group of persons is appropriate, will be
considered during the project. Uses of healthcare records for other
purposes such as administration, management, research and epidemiology,
which require aggregations of individual people's records, are not the
focus of this standard but such secondary uses could also find the
standard useful.

The Architecture places no restrictions on the communication of the EHR
with respect to the location, the means used, and the timing of the
communication. Communication is defined as the act of imparting
information, and this standard does not restrict how that should be
done, permitting, for example the interchange mechanism to take the
form of either a message or a system view using e.g. middleware with
component technology.

The Architecture is therefore independent of organisation, (e.g.
secondary or primary care records), and independent of temporal
categories that are applied to records of care (e.g. episodic or
longitudinal). The Extended Architecture also makes minimal assumptions
regarding circumstances of its use. For example, it does not assume a
particular decomposition of the healthcare domain nor does it assume
that systems that might use this standard will be of a particular
implementation type or configuration. In particular, the fact that this
Reference Architecture is represented conceptually by an object-
oriented notation does not require conformant instances to be
implemented using object technology.

The revision of the ENV 13606 pre-standard will take into account the
experiences of implementations of the standard and the following new
standards developments:

. The principle of separating (1) a basic record reference architecture
from (2) domain specific models, the latter that have been called
archetypes.

. The CEN/TC 251 work on a standard for General purpose information
components that in its turn is partly based on developments that have
taken place in other organisations, for instance within the HL7
organisation for a reference information model.


This new revision by the Task Force needs to take into account the
following factors.

1. The new standard needs to achieve a fine balance between being:

. a robust, rigorous and complete set of models meeting published
requirements for generic health record information and the appropriate
access to it; and
. practically implementable, neither overcomplicated nor specifying areas
for which a definitive approach has not yet been established.

2. Since its publication much practical experience has been gained in
attempting to refine and implement ENV 13606 across Europe, both by
industry and in many pilot demonstrator settings. Much of this experience,
and the important lessons learnt, have not yet been widely disseminated.

3. The R&D inputs on which ENV 13606 was based have moved forward since
1998 and important new contributions to the field should be taken into
account in its revision.

4. In addition to a traditional message-based communication between
isolated clinical systems, the Electronic Health Record will in some cases
be implemented as a middleware component (a record server) using
distributed object technology.

5. "Customers" of such record services will be not only other electronic
health record systems but also other middleware services such as security
components, workflow systems, alerting and decision support services and
other medical knowledge agents.

6. There is wider international interest in this CEN work, and valuable
experience from beyond Europe can helpfully contribute to this revision.

7. HL7 is engaged in a significant revision of its information models, with
a partial overlap in purpose to this and other CEN activities.



2 General Approach

Since the announcement of the Task Force a number of parties have expressed
concern that the new revision should not present a radically new
information architecture for the EHR, but should aim to build on the
existing ENV. Other views have been expressed that some aspects of that ENV
were not easy to implement, were ambiguous, or considered unnecessarily
complex.

The Task Force declared, at the February 2002 CEN meeting in Berlin, the
intention to build on the existing ENV and to use implementation experience
and new generic requirements as the basis for the inclusion of new
constructs. It is also important for the work to remain focused on the EHR
as the persistent longitudinal and potentially multi-enterprise or multi-
national record of health and care provision relating to a single subject
of care (the patient) in order to inform the subject's future health care
and to provide a medico-legal record of care that has been provided. Whilst
an EHR service or system will need to interact with many other services or
systems providing terminology, medical knowledge, guidelines, workflow,
security, persons registries, billing etc. the Task Force scope should only
touch on those areas if some persistent trace of such interactions is
required in the EHR itself. The general principle of the Task Force should
be, where appropriate, to rely upon the existence of such services and not
arbitrarily to extend its scope to subsume these other significant areas of
health informatics.

The Task Force has to balance the need for improvements and advances in the
field to be taken into account with the need for changes to the existing
ENV to be justified and of benefit for future interoperability. The
eventual standard may offer a practical and useful contribution to the
design of EHR systems but might only be realised as a common set of
external interfaces or messages built on otherwise heterogeneous clinical
systems. The level of prescription in the standard needs to take into
account that the majority of deployed clinical systems will not be complete
EHR systems for some years, and that the current levels of health ICT
spending in most Member States is low in comparison with other industry
sectors, offering only a modest opportunity for radical systems redesign.

One significant area of change in the existing ENV has already been
proposed and has gained strong acceptance from many members of TC/251: the
use of Archetypes. This form of metadata about the EHR has dual origins in
work arising from the EU Project Synapses (1996-8) and subsequent parallel
work of former GEHR collaborators working in Australia. These concepts have
been harmonised through the OpenEHR Foundation. The work has been widely
recognised as an important complement to the core Reference Model of the
EHR, as a means of defining the domain specific hierarchies and templates
to be used within healthcare and of specifying constraints that should be
applied to the instantiation of the EHR at run time to ensure consistent
data quality and the reliable sharing of EHR entries. The Archetype
methodology serves as an important bridge between the normative
requirements for representing the EHR and the natural and inherent
diversity and evolving nature of clinical information, by providing a
standardised way in which that diversity can be represented.

Another significant consideration is the present work of HL7 in developing
the version 3 Reference Information Model, and the use of this to specify
CMETs and HMDs. CEN TC/251 has already formed a relationship with this
work, and a well-advanced CEN Project Team has developed a draft set of
General Purpose Information Components (GPICs) that build on the RIM and
map these to a number of existing CEN standards. The Task Force has
proposed to utilise this work as the basis for exploring the appropriate
information interface to HL7, in order to take advantage of the expertise
that has already been acquired in Europe in this area and to ensure that
the future TC/251 standardisation field remains internally consistent. For
similar reasons, it has been informally agreed to work in collaboration
with the new Task Force that has been proposed to revise the original HISA
standard (ENV 12967).

The EHRcom Task Force has an exciting opportunity to take forward a good
pre-standard, in the light of the current climate reinforcing the
importance of well-informed clinical shared care, with health service
organisations increasingly gravitating towards regional health care
networks, and with increasing requirements of clinical information systems
to support this kind of interoperability.

The EuroRec Institute and the OpenEHR Foundation have indicated their
support to this Task Force, and our hope is that the publication of the
standard by CEN can be partnered by the publication of educational
materials, guidelines and one or more OpenSource reference implementations
that demonstrate how the standard might be used in practice.

The members of the Task Force so far identified share in this belief that a
good job can be done, and they are willing (enthusiastic!) to participate
actively in achieving these goals despite the lack of any identified funds
to date.


3 Work-plan approach

The general work-plan approach of each Task defined within the Task Force
will need to recognise the cyclical relationship of industry implementation
experience, new requirements and new R&D results to the standards-making
process, as depicted below.

[pic]


1 The cyclical evolution of specifications and standards





The most important first phase of the Task Force is to elicit inputs.
Examples of these are given below.


2 Implementation experience

. Industry - direct experience of implementing ENV 13606 based systems
. Industry fora e.g. via ProRec Centres and EHTEL
. National or regional EHR demonstrator sites
. The OpenEHR Foundation (combining EU and Australian record server and
archetype implementations)
. Other academic ENV 13606 - based systems and prototypes
. Any other comprehensive and open EHR architectures in clinical use


3 Health information stakeholders

. Patient groups and legislation
. Healthcare professional groups
. Regional and national policies and projects, taking healthcare
delivery and scientific trends into account e.g. trends in
bioinformatics
. Other CEN standards: e.g. GPIC, HISA, Categorial Structures, ContSys
. International health informatics standards e.g. HL7, OMG HDTF
. Requirements sources e.g. ISO 18308 (draft, incorporating requirements
from GEHR, Synapses, EHCR-SupA, I4C, RICHE, Nucleus, SPRI, US sources
and many other projects).


4 R&D results

. EHCR SupA recommendations to CEN
. Synapses and SynEx federated health record services
. InterCare and PICNIC tele-health record systems
. I4C integrated cardiac records, based on ORCA
. HANSA and its ancestors
. HARP security and record components
. Many other projects..


2 Involving industry

As stressed earlier, important implementation lessons have been learned and
probably the most critical liaison to nurture during the Task Force
lifetime will be the link with industry, initially to gather this feedback
and later to sound out reactions to proposals at an early stage.


1 Feedback we need to gather from pilots

. Which parts of the standard have been tackled in your pilot/system?
. Which constructs (classes, sections etc. ) have actually been
implemented?
. Which constructs were well-matched to your requirements, and which
proved a poor fit?
. What additional/new requirements need to be addressed by the Task
Force?
. Which classes and attributes were easy to understand and to implement?
. What obstacles did you experience (comprehension of the standard,
software engineering of certain classes, practical deployment issues,
performance etc.)?
. What changes to ENV 13606 would you recommend?
. Which features in ENV 13606 do you feel strongly about retaining?

A draft letter, in the form of a questionnaire, is appended to this
document. Readers of this are welcome to forward this letter to any
relevant organisation in order to elicit such feedback or for onward
dissemination.



4 Technical Approach

In drawing on the structure of the existing pre-standard, and recognising
the inclusion of the archetype methodology, the following core Tasks have
been proposed by the Task Force leader. It is not to be assumed at this
stage that each Task will give rise to an independent part of the new
standard, nor even that Task outputs will all be normative. These Tasks
represent significant areas of work requiring different expertise and
drawing on different areas of existing normative and non-normative
background work. The goals of each Task presented here are the proposal of
the Task Force leader, and on which discussion is welcome.

1 Reference Model (Task RM)

Task Manager (WGI) TorbjÜrn Nystadnes
To define a generic information model for representing the electronic
health record of any one patient, as a refinement of ENV 13606 part 1,
drawing on implementation feedback and relevant work in HL7 as incorporated
into the GPIC standard.

2 Archetype Model (Task AM)

Task Manager (WGI) Dipak Kalra
To define a generic information model for representing the definition of
individual instances of Archetypes. This work will draw particularly on
work arising from the EU Synapses project and from Australia, now
integrated through OpenEHR.

3 Archetype Generation (Task AG)

Task Manager (WGII) Jean Marie Rodrigues
WGI Liaison Angelo Rossi Mori
To generate a wide range of Archetypes reflecting a diversity of clinical
requirements and settings, as a "starter set" for adopters and to
illustrate how other clinical domains might similarly be represented (for
example by health professional groups). It will be relevant to draw on CEN
TC/251 WGI standards such as GPICs, WG II standards such as Categorial
Structures and on OpenEHR examples. It is proposed at this stage to leave
open the decision about whether any Archetypes should be published in the
Normative part of the standard. These might be provided only for guidance
to assist developers in different countries and other contexts to develop
their own Archetypes.

4 Terminology Support (Task TS)

Task Manager (WGI) Angelo Rossi Mori
WGII Liaison Jean Marie Rodrigues
Both the Reference Model and the Archetype Model will include attributes
whose values should themselves be drawn from enumerated lists, whether
normative or informative. Some values might appropriately be defined by
external terminology systems. This Task will identify which lists are
appropriate and provide enumerations of them, drawing on the previous
Domain Termlist part of ENV 13606 and subsequent work in Working Group II.

5 Security Features (Task SF)

Task Manager (WGIII) Bernd Blobel
WGI Liaison David Lloyd
To define those information model concepts that need to be reflected within
individual EHR instances to enable suitable interaction with the security
components that are anticipated to be required in any future EHR
deployment. This is likely to include information to:

1) ascertain and trust the authorship of individual EHR entries
2) represent the author's and/or patient's consent for the disclosure
of all or part of the EHR
3) represent the actual accesses to a patient's EHR .

The work will draw on ENV 13606 Part 3 and experience from Working Group
III.

6 Exchange Models (Task XM)

Task Manager (WGI) Edgar GlÝck
To identify the requirements of the different means of exchanging record
information and to propose a set of models that build on the above Tasks
and can form the basis of message-based or service based communication.
This may need to include the request specification as well as the models by
which the response is represented, and deal with the communication of both
EHR and Archetype instances. The work will draw on ENV 13606 Part 4 and
other standards from Working Group I. Interest has been expressed in having
an informative version of the standard in XML Schema.

7 Horizontal Task: Liaison with Industry (Task LI)

Task Manager (WGI) Alain Maskens
To provide a channel for encouraging and receiving input from industry on
their experience with implementing ENV 13606 and other requirements they
have of the new standard. Later, to provide a means of co-ordinating the
dissemination of early drafts of the standard for feedback. This Task will
take advantage of the networks established by each national standards
mirror panel, by ProRec Centres and by EHTEL.

8 Horizontal Task: Documentation and Dissemination (Task DD)

Task Manager (WGI) Patrick Lefebvre
To review the work output of each other Task from the point of view of
educational requirements, and to collaborate with each Task to develop
suitable materials to assist non-experts to gain an understanding of the
standard and implementation guidance for industry; such materials might not
all form part of the standard itself but might be made available through
other channels such as OpenEHR and the EuroRec Institute.



9 Task Organisation

Each Task Manager will champion the cause of his Task, identifying
expertise and eliciting contributions, working collaboratively and
democratically to synthesise input and propose successive specification
drafts. He may need to explore some difficult or controversial issues and
seek wider input and support on those, including cross Task collaboration
and input from the wider CEN community.

Each Task will have:
. Active participants: this should be several persons (<10), adopting an
e-working approach to discussion and document sharing
. Contributors: those who have experience or other relevant input to
offer
. Reviewers: those who will wish to closely monitor the outputs of the
active participants and provide feedback on internal drafts and
working papers before these are circulated to the wider Task Force or
TC for comment.

Each Task Manager is being asked to provide a mission statement and an
outline of the main activities (primarily for 2002 at this stage), plus an
indication of what will be delivered by the end of 2002 and by the end of
the Task Force. These deliverables might extend beyond the intended content
of the standard itself.


10 E-Working Facilities

TC/251 and SIS have established the Alta Vista Forum site for the support
of e-working, at:

http://www.centc25.org/altavistalink.htm

This has been customised for the Task Force by Christina Strange (SIS) and
David Lloyd (UCL), as described below. SIS will arrange the regular backup
of the site. Readers unfamiliar with the TC/251 Alta Vista Forum are
advised to read Christina's user guide document first, available from her
by e-mail (christina.stange@sis.se).

The whole TC/251 Forum is restricted to registered members - so you will
need to register before you can get in (A number of TC members are already
registered, so check first).


1 The TF13606 EHRcom Forum

This overall Forum is open to access by all members of TC/251. A folder for
the Task Force has been created as a sub-folder under TC/251. This folder
is intended to permit members to:

. host an open discussion group relating to the overall Task Force (root
of TF13606 EHRcom)
. offer contributions and feedback (Contributions sub-folder)
. review drafts published by the Task Managers (Documents for Review sub-
folder)
. hold definitive publications from the Task Force (Documents for
Publication sub-folder)

Screen shots of the TC/251 folder, and of the TF13606 folder, are shown
below.





[pic]


[pic]




2 EHRcom Teams

These are private Teams defined within the site for close collaborative
working, one per Task. These are restricted to the Task Manager, Active
participants and the Task Force leader. Each Team site is to be moderated
by the Task Manager with respect to membership, documents and the
discussion.

Active participants may join more than one Team but only if they are
seriously working on the Tasks: each Task needs to be open and transparent
but we also need to permit these groups to get down to matters of fine
detail which is well-known to be more effective when the number of
participants is small. "Good" drafts and position papers will be posted on
to the TF13606EHRcom Forum for wider review.

To access the Team site, choose the Summit option from the Forum pages. You
will be taken to a screen like that shown below - it will only show the
Teams for which you are a member.
[pic]

The main page for each Team is shown below. It is important that members
avoid choosing the Team Properties Icon - please leave this for the Task
Manager only. The main area for e-working is under Documents and
Discussions.

[pic]



3 How to become involved

If you wish to become an Active Participant in one of the Tasks, please
send an e-mail to the Task Force Leader with a short description of the
experience and expertise you wish to bring to the Task. These requests will
be forwarded to the Task Manager to allow them to assemble their core
members.

If you have a contribution to offer to a Task, please do so via the
TF13606EHRcomForum, using the Contributions sub-folder. Please prefix your
contribution name with the two-letter Task acronym. If you have made a
contribution we would very much hope you will become a reviewer.

If you wish to become a reviewer, please send an e-mail to the Task Force
Leader indicating which Tasks you wish to follow closely. Your name will be
added to an announce mailing list informing you of documents posted on the
Forum by that Task Manager (in the sub-folder marked Documents for Review).
Any member of the Alta Vista Forum is able to access these folders, so you
do not have to "register" as a reviewer unless you wish to receive e-mail
notifications.

Several other Task Force participants were identified at meeting in Aix-en-
Provence in November 2001 and in Berlin in February 2002. These members
have not been listed in this document but will be included within the
templates produced by Task Managers in the coming weeks.

These guidelines may be revised inviting you to contact Task Managers
directly in the future.


5 Draft time-table

The first major publication of results by the Task Force is the FWD due in
January 2003. Ideally this should contain a first good draft of the entire
standard. However, in reality the Reference Model is the key aspect that
industry will need to review forst, and progress in many other Tasks will
be to some extent dependent upon this being stable. The priority will
therefore be to this Task being carried out urgently with successive drafts
available in the autumn of 2002, so that the FWD is not a first airing of
the Task Force proposals for this.

The draft timetable below attempts to reflect the phases of the work of
each Task, starting with gathering input. The Reference Model and Security
Features Tasks should aim to be at a near definitive point by the time of
the FWD. The others should have substantive proposals but realistically
might need further active drafting in the light of the stable RM. In
particular, Archetype Generation might lag behind the others as it will be
dependent upon authoring tools that can only be updated from those
available now once the RM and AM are stable.

[pic]


6 Task Templates

The following draft template is to be completed jointly by each Task
Manager and the Task Force leader over next few weeks. The set of these
will be circulated via the Alta Vista TF13606 EHRcom Forum.


|TASK NAME: |
| |
|ACRONYM: |
|Task Manager: |
|Mission Statement |
|Main Activities |
| |
| |
|Expected Deliverables |
| |
|Initial Activities |
| |
|Active Participants (members of the Alta Vista Team) |
| |
|Known Contributors (this list may be updated frequently) |
| |
|Known Reviewers (this list may be updated frequently) |
| |
| |
|Date last updated: |





CENTRE FOR HEALTH INFORMATICS AND MULTIPROFESSIONAL
EDUCATION (CHIME)

4th Floor, Holborn Union Building Direct Line: 020-7-288-3362
Archway Campus Fax: 020-7-288-3322
Highgate Hill E-mail: d.kalra@chime.ucl.ac.uk
London N19 3UA
February 2002


INVITATION TO CONTRIBUTE TO THE WORK OF THE
NEW CEN TC251 TASK FORCE ON THE EHR

TO: Companies or organisations active in the field of EHR development
Circulated c/o: CEN TC251 national mirror groups
The EUROREC organisation
The EHTEL organisation

The TC 251 of CEN has recently created a new Task Force on the electronic
health record. The objectives of this Task Force are to produce a rigorous,
generic and clinically adaptable information architecture for representing
the EHR, building on the current CEN standard for EHCR Communication (ENV
13606), in order to support the interoperability of systems and components
that need to interact with EHR services.

The Task Force has identified, as an important prerequisite for the success
of its work, to obtain an input from those IT companies or healthcare
organisations which have implemented features of the current EHCR pre-
standard in their current products or services.

If your enterprise does fall into this category, we would very much
appreciate receiving your views and comments, preferably structured on the
basis of the accompanying questionnaire (Annexe 1). In addition to this
questionnaire-based input, the Task Force will invite companies or
healthcare organisations with a strong commitment to the standard to
demonstrate their products at the TF meeting which will be held in Madrid
on 2002-06-03. If your enterprise is interested, please do also fill in the
corresponding application form (Annexe 2).

It will be useful for the organisation of our work to receive these forms
by 2002-05-15.

We thank you in advance for your contribution and look forward to receiving
your contribution to this important standards-making process.


Dr. Dipak Kalra
Task Force Leader

PS: Please note that this task force is not a funded activity. Your
possible participation in the meeting and demonstration will therefore
regrettably have to be at your own expense.
ANNEX 1
(Please extend the space in each section below as required)


Which parts of the standard have been tackled in your pilot/system?

Which constructs (classes, sections etc.) have actually been implemented?

Which constructs were well matched to your requirements,

and which proved a poor fit?

What additional/new requirements need to be addressed by ENV 13606?

Which classes and attributes were easy to understand and to implement?

What obstacles did you experience (comprehension of the standard, software
engineering of certain classes, practical deployment issues, performance
etc.)?

What changes to ENV 13606 would you recommend?

What features in ENV 13606 do you feel strongly about retaining?



ANNEX 2

APPLICATION FOR DEMONSTRATION OF AN EHR APPLICATION
CONFORMANT WITH ENV 13606 of CEN TC 251

(Please extend the space in each section below as required)


. Name of company or organisation:
. Address
. Contact person
. Product name
. Brief product description



. Type of healthcare organisation in which the product
. Can be used
. Is being used

. Approximate number of current users:
. Countries in which the product is being used:
. Communication capabilities of the product;
. Specialised messages
. In
. Out
. HCR extracts
. In
. Out

. Main ENV 13606 features implemented:





-----------------------
[pic]