A newsletter from CEN TC251 The value proposition is … 4th Newsletter... · quality interoperability standards for health within Europe. Welcome and our wishes of Seasons greetings

Dec. 2013

The 4th newsletter from CEN/ TC 251

The value proposition is to deliver de jure,

quality interoperability standards for

health within Europe.

Welcome and our wishes of Season’s greetings to all of our readers! The

previous Newsletter focussed upon how standardisation activities were

resourced. The emphasis in this issue is more upon results and the

promotion of our current work. We report on the on-going activities of

our TC 251 experts and the related activities with respect to FP7 projects,

European initiatives, and, further afield, in ISO and with the Joint Initiative

Council. As usual, we showcase selected work that is of interest to the

community, provide new updates on current work items, and discuss

topical issues.

Inside this 4th newsletter

Socialising the Standards 1 Concurrent Use 10

“Imagine there’s no …” 2 SemanticHealthNet 12

For the Record 3 Updates 13

Region matters 7 The New Year 15

Page | 1

Socialising the Standards For many, this time of year is a festive time. One which conjures up the thoughts of parties, dancing

and music, eating and drinking, a time for families to gather together, for present giving, receiving

and, perhaps, too for discretely disposing of the unwanted presents. It is a time for sharing best

wishes with distant friends and a time when people seem a little more courteous and friendly

towards mere acquaintances and even towards complete strangers. It is typically a very social

occasion, sprinkled with over-indulgence and a general feel-good factor that is almost tangible.

Sadly very few of these characteristics would seem to apply naturally to standardization (all the

people involved in the business are lovely, and of course, this fact goes without saying!).

Yet it has become quite common over this last year to hear these same wonderful

people speaking of the need to ‘socialise the standards’! To many it will be an alien

concept. It is certainly not a common action or defined term as far as we can tell.

When we used ‘Google’ to shed some light on this term, the first hit was a ‘Safer

Socialising Award’ from the Association of Business Crime Partnerships, and another was

about training a ‘puppy dog’ to have pleasant encounters with others! On the same page, however,

there was a reference to a more promising article on ‘Multi-stakeholder regulation: privatizing or

socializing global labor standards?’ but there was no available abstract, and we were too mean to

pay (Scrooge?). So in the spirit of standards developers everywhere, we define ‘socialising the

standard’ to mean the following (only in this particular document, of course!): Introducing a

specification document to a complete stranger in a meaningful way so that after their encounter they

develop a mutual, valued and long-term relationship.

Whatever the real provenance of the concept ‘socialising the standards’, it speaks of a need to

overcome a real barrier that currently exists and separates the standards developer from the would-

be user on so many levels, mismatching entire worlds with apparent ease. With respect to eHealth,

we identify 3 points of social alienation, defined as being "a condition in social relationships

reflected by a low degree of integration or common values and a high degree of distance or isolation

between individuals, or between an individual and a group of people in a community or work

environment."[1]:

First, there is a need to introduce the ‘newcomer’ to the world of useful and existing

documents that they are seemingly unaware of but which are nether the less believed by

SDOs to be relevant and important for the newcomer’s business.

Second, there is a need to support these strangers or outsiders, providing guides and

explanations to unlock the arcane secrets that specifications hold within them. Whereas, no

one doubts that SDO specifications could be better written and be more informative, it is

still the case that the technical nature of the subject matter will nearly always require more

explanation to permit safe implementations.

Third, the outsider must be welcomed and feel able to step inside and become comfortable,

perhaps as an insider themselves, although that is not a requirement! It is after all their

business. They should be confident and empowered to comment, to critique and to request

changes to existing standards and even to demand new things when nothing else satisfies.

The onus clearly seems to be on us as an SDO to make the first move, to make the introduction and

to provide the explanations. This newsletter then is all about ‘socialising the standards’.

Page | 2

“Imagine there’s no …”

Good standards are invisible. They are developed and used to get something done, and if it is done

well, then no one pays them attention. The standards (and the standards’ developers?) are taken

for granted and are the unsung heroes of progress.

For example, imagine life in a world where:

…credit cards were different sizes?

…light bulbs didn't fit into lamps?

…railway lines were different widths?

…microwave ovens emitted large amounts of harmful

radiation? [2]

The above are just a few examples of success in the standards’ world that raise no comment and

merit no discussion or complaint from users. Often, the users of these standards are simply unaware

of the role a standard plays or even of its existence.

Now, if you will, imagine life in a world where:

… records have different structures & semantics?

… clinical systems are functionally incompatible?

… different interchange capabilities exist?

… systems are designed without appropriate patient safety standards?

… new medical devices and new clinical Apps go unregulated? Etc.

“Imagine there’s no [standards]; its easy if you try” [3]. Actually no imagination is required, at all,

as this situation is simply fact! People are surprised, if not angry, that this is the case; they have

assumed that these standards are straight-forward, that they already exist (some do), and

furthermore they believe that those that exist work well, are useful for interoperability, and are

adopted enthusiastically by all. Unfortunately, they are wrong.

So, are Health Information Standards of value? Are they used? Are they useful?

– How can we show, tell, or even know?

"In all affairs it's a healthy thing to hang a question

mark on the things you have long taken for

granted." – Bertrand Russell

Page | 3

For the Record

Perhaps the most identifiable artefact, common place and mundane asset in Health Informatics is

the ‘record’. It is, in one sense, the perfect starting point or topic on which to ‘hang question marks’.

It is the object par excellence for Health Informatics, and it has been used for clinical purposes well

before the computer came into being, probably originating from the time the first clinician

attempted to bring order to his/her thoughts. It has been targeted both by research and

standardisation since the new discipline was named back in the 1970s. The record has been quested

after from the outset and has warranted terms such as ‘grand challenge’ and even the ‘Holy Grail’,

signifying attempts to describe the inherent levels of difficulty and its elusive and magical nature

respectively.

There are many types of record in our domain, but probably the most common terms for this object

are the ‘electronic health record’ (EHR), the ‘electronic patient record’ (EPR) or more recently the

‘personal health record’ (PHR). There are multiple standards, definitions and scopes for each record

type, and there are myriads of implementations of each type, albeit that consensus is far from

universal and the quality of product and service is variable.

These records, however, are perceived as being the silver bullet, with the potential to cure all our

ills, both economic and health related. They are deceptively easy to imagine…

By David Goldman, CNNMoney.com staff writer Jan 12, 2009: 4:05 AM ET President-elect Barack Obama, as part of the effort to revive the economy, has proposed a massive effort to modernize health care by making all health records standardized and electronic. Here's the audacious plan: Computerize all health records within five years. The quality of health care for all Americans gets a big boost, and costs decline. Sounds good. But it won't be easy.

Goldman’s assessment, “Sounds good. But it won’t be easy”, is a classic understatement that has proven to be true. Others have believed that instant results are achievable from off-the-shelf solutions; unfortunately, the same assessment applies as this has not been found to be even close.

June 27 2011

Google Inc. announced that its PHR service will be retired on Jan. 1, 2012. A senior product

manager for Google Health, said the product has not achieved the “broad impact” … hoped.

Though “tech-savvy patients and their caregivers, and more recently fitness and wellness

enthusiasts” have been using Google Health, the company could not “translate that limited usage

into widespread adoption”

So we need to ask the questions… Are record standards of value? Are they used? Are they useful?

– How can we show, tell, or even know?

Page | 4

In the 50th year and anniversary of the popular BBC’s ‘Doctor Who’ television series, we might pose one more question in a timely, albeit irreverent way. Imagine… In the slideshow, the Dalek* moves from top left to bottom right, revealing their latent threat and aspiration for world domination. (*Note: SDOs, policy-makers and researchers all have at least one thing in common, they all thrive on acronyms!)

As outraged Health Informaticians around the world rush to the defence of the misunderstood EHR,

we would also like to flag up a little hope of our own, and briefly indicate some current

‘record’ activity occurring on a number of fronts.

Perhaps because experience has shown the complexity of constructing the all-singing, all-dancing

record, there have been a number of policy-led initiatives that seek to do something with a more

constrained version or subset of the whole record.

In accord with America, Europe is focussing (and has been for some while now) on the idea of

creating and exchanging an agreed ‘summary record’. It has even become an operational part of the

Memorandum of Understanding (MOU) between the two realms. In conjunction with these efforts,

there is the EU-US eHealth/Health IT Cooperation Initiative. This initiative supports an innovative

collaborative community of public- and private-sector entities, including suppliers of eHealth solutions,

working toward the shared objective of developing, deploying, and using eHealth science and

technology to empower individuals, support care, improve clinical outcomes, enhance patient safety

and improve the health of populations.

You can find the recording of all the recent teleconferences and documentation via:

http://wiki.siframework.org/EU-US+eHealth+Cooperation+Initiative . If this is of interest to you or your

organisation, please consider joining the calls and participating.

Page | 5

CEN/TC 251 is linked to this EU-US Cooperation Initiative activity by our participation in the EU project ‘Trillium Bridge’, which is the FP7 research funded activity to exchange patient summary records between the EU and the US. This project is a €200000 project over 18 months and NEN, as a representative of CEN/TC 251, was an original part of the successful bid. Trillium Bridge is focussed upon patient and clinician mediated exchange of patient summaries using epSOS on the one hand

and the Meaningful Use initiative from the US on the other; the goal is to see what is feasible and to understand the implications for making this real in the future. Its specific objectives are to bridge the divide by:

Identifying appropriate use cases Assembling Interoperability assets Compiling a gap analysis Developing a feasibility study Facilitating policy alignment by utilising expert partners, including those from the

standardization community.

More strategically, Trillium Bridge has the goals to:

Create opportunities for transatlantic business engagement Reduce implementation/configuration costs Decrease standards development costs Accelerate convergence towards global standards Take the First steps towards realizing the vision of the MoU

The first kick-off meeting of Trillium Bridge was in Boston Massachusetts in September 2013. We

believe the project to be important, not least because it is likely to set future agenda activities for

both policy and standardisation in the interchange of summarised records containing clinical data.

‘Meaningful Use’ is to enable interoperability in the US; epSOS has been designed to enable cross-

border sharing in Europe. Trillium Bridge to bring the best of the work together is a compelling

story, and CEN with the other SDOs may have a role within and beyond the project to take pilot

outputs and turn them into formal standards that are based on working pilots or implementations.

In a separate initiative, the eHealth Network on the 19th November 2013, have unanimously adopted

the first release of the ‘Guidelines on Minimum/Non-exhaustive Patient Summary Dataset for

Electronic Exchange’ in accordance with the cross-border directive 2011/24/EU. The 3rd meeting of

the eHealth Network in May 2013 supported the use of basic and extended Patient Summary (PS)

datasets and these guidelines are the outcome of those agreements. There are two foci: the primary

one being “to support the objective of continuity of care and patient safety across borders” and the

secondary one is “for reference use at national level”. The use cases addressed by these guidelines

relate to emergency or unplanned care. It is important to note that these guidelines are ‘non-

binding’ and should be viewed as a set of recommendations for advice only.

Page | 6

The guidelines have been informed by the epSOS pilot. However the latter introduced the clinical

concept of a “maximum” set of information that may be sent for the specific epSOS purpose

whereas the guidelines work takes MS capability as its major criterion. As a result, there are some

differences between the pilot implementations in epSOS and the guidelines, which introduce the

concepts of basic and extended datasets for exchange.

The stated aim of the guidelines is to “enable Member States to understand not only what data is to

be included in the PS but also to assess the implications of adopting such a PS in practice...”

Consequently, the guidelines document is seen as a ‘live’ or evolving document and the 2nd release is

scheduled for May 2015, when it is to be “updated on the basis of technical developments and

feedback from users...”

Invitation to share experiences on EHR/PHR programmes and standards

CEN/ TC 251 would also like to gather feedback about the use and abuse of different types of records within Europe. There is school of thought that suggests there is a switch from EHR into PHR prioritisation and development. We should like to document any such change in policy and practice and invite all to tell us what is happening on the ground and whether or not there is such a shift within the European member states. The intent is for the TC to provide information about relevant, existing standards as appropriate, and to understand better how the requirements and experiences of European stakeholders compare with those within the US. The goal will be to learn more so that we can satisfy future requirements.

Please use our CEN/TC 251 Health Informatics facility or contact our secretariat directly ([email protected])

Current EHR/PHR standardization activities in ISO

As well as the ongoing revision of EN ISO 13606, there are two other standardisation initiatives in the

records area that have undergone ballot at this time and both are relevant to these issues:

ISO/HL7 10781 – Electronic Health Record Functional Model, Release 2 and

ISO/HL7 16527 – Personal Health Record Functional Model Release 1.

In short the projects are scheduled as below (these expected dates may change):

ISO/HL7 10781 - EHRS FM Release 2 7th January 2014 - Joint Ballot Closes January - Ballot Reconciliation February 2014 – Publication

------------------------------------------

ISO/HL7 16527.2 - PHRS FM Release 2 3rd December 2013 - Joint Ballot Closes (Passed) December - Ballot Reconciliation January 2014 – Publication

Page | 7

Region Matters

It is always a difficult task to classify standards (hence the new work item ISO TS 18528 – Health informatics standards functional classification, 2013 – being led by Andrew Grant of Canada). The new work related to records mentioned above, the

FP7 projects and the concurrent use initiative could as easily be mentioned under this ‘Region Matters’ heading. In truth they multi-task well! Here, though, we would mention just

three things: 2013, Europe’s Year of the Citizen

The pharmacy-related part of the epSOS project

And the idea of a European standardization collaborative

2013, Europe’s Year of the Citizen As one emerges from the Schuman metro station in Brussels, it is almost impossible to miss the huge

banner proclaiming 2013 to be Europe’s year of the

citizen. We suspect not many people know that, or are

aware of its intent and significance. It is a little abstract

and remote, and perhaps the people on the ground are

just too close to appreciate the sentiment. We suspect

too that the Commission knows all this too, and hence the

marketing folk have tried to concretize the ideal in a

snappy slogan, “Its about Europe; its about you”.

We note too that this slogan is equally applicable to our

‘CEN/ TC 251’, and also to our take on ‘socialising the

standards’, in that we are trying to make the abstract a

little more meaningful.

The World Health Organisation made a declaration in 1948 defining ‘health’ to be

“... a state of complete physical, mental and social well-being and not merely the absence of

disease or infirmity”.

In 1986 two amendments were made to the above definition:

“resource for everyday life, not the objective of living”, and

“health is a positive concept emphasising social and personal resources, as well as physical

capacities”.

This declaration is repeated in the introduction to the System of Concepts for Continuity of Care

specification (ContSys, see page 14). In this festive season it is worth reminding ourselves why we

do this and what the main driver of Health Informatics is. The technical standards and specifications

can be dull and dry, but they are one important means of integrating health and care, and of

improving the quality of both. The standards speak of inclusion, and perhaps at this time, we can

take further liberties with ‘socialising the standards’ and suggests a further objective beyond

awareness, speaking also to the ultimate benefit of our work, ‘Health first’.

Page | 8

epSOS: ePrescriptions CEN/ TC 251 was asked to review the final deliverable of epSOS work package 3 related to the

transmission of electronic prescriptions. CEN experts reviewed the material and completed the ‘soft

questionnaire’, the results of which are included, in full, in the WP3.D appendix.

TC 251 is active in many of the central areas of the epSOS project, but in this pharmacy context we

specifically referred the project lead to the following:

EN ISO 17523, Requirements for electronic prescriptions

EN ISO DTS 19256, Requirements for Medical Product Dictionaries

EN ISO DTS 19293, Requirements for a record of the dispense of a medicinal product

EN ISO 19294, Data elements and structures for identification of extemporaneous and

magistral (compound) pharmaceutical preparations without marketing authorisation

The first of these is close to being published, and the other 3 are in the early stages of development,

and we would welcome input from interested, expert parties.

EpSOS has been extended for a brief spell, but there will be other follow on activities. In particular,

it is still necessary to bring through its results for standardization so as to ensure the widest public

availability of its work. CEN/ TC 251 looks forward to further opportunities to help and collaborate.

The European standardization collaborative The last issue of the newsletter introduced the new European Multi-Stakeholder Platform for ICT Standardization (MSP), which seeks to provide a horizontal cross-sector approach to the market. Benoit Abeloos on behalf of the Commission brought eHealth to the attention of the platform. A presentation was also given by the CEN/ TC 251 Chair. The two presentations raised a number of questions as to how eHealth might be addressed. To provide some answers, a summit was convened and hosted by TC 251 that reached out to members of the platform and included representatives from the Commission, the standardisation bodies within the JIC, ETSI and OMG as well as commercial players such as COCIR. The summit concluded that coordination of the eHealth specifications needed to be strengthened to be able to respond to the needs of the respective stakeholders. The summit was essentially asked two things by the Platform: Was it appropriate to create a new body to do this, and secondly was the ‘task force’ idea a viable solution to accomplish this? The response was clear. We did not require an entirely new organisation, which would merely add a layer of bureaucracy and duplicate the functions of what was already there. However given the challenge and complexity of the eHealth ecosystem, it was also clear that we needed to work together more collaboratively and in a new way to fix the problems and improve outcomes. The idea of a virtual collaboration was raised and a proposal made for an eHealth Specification Platform (eSP) comprising independent organisations, taking upon the task of coordination of eHealth standards across Europe. A preliminary list of 14 organisations was identified. Although the eSP might be considered to be like the Joint Initiative Council in some respects, the more eclectic membership involving policy makers and industry mean that the model is more similar to the Canadian standards collaborative, but extended still further across the multiple countries of Europe.

Page | 9

As this collaborative was perceived to have an on-going advisory function as part of its remit, the idea of a time-limited task force as a solution was ruled out. CEN/ TC 251 perceive a double role for the eSP:

1. providing consistent standards-related advice to the MSP and all other European initiatives,

rooted in a global eHealth perspective and

2. taking an active role in delivering eHealth specifications, as developed in a European context, fit

for endorsement and adoption across the membership of participating eHealth organisations, in

close collaboration with national eHealth programmes and national eHealth competence

centres.

A second presentation reflecting the answers and position were made to the MSP. The next steps are to:

discuss the proposal with the member states through the eHealth Governance Initiative and eHealth Network,

discuss with national eHealth competence centres and explore the eSP contribution to the adoption of epSOS and/or eHealth Network specifications.

These discussions are particularly important because there are several initiatives that are intent on

producing a better coordination and a more sustainable approach to eHealth applications within

Europe. The vision for future collaboration has to be clear and inclusive of the major stakeholders.

It is important too that responsibilities and scope are clearly defined to avoid a fragmented and

ultimately unproductive way forward. The following stakeholder map is admittedly an over-

simplification of parties and roles

that the EU affect in general, but any

effective collaborative envisaged has

to address the whole picture; that

includes stakeholders working

together within the regional context

that underpins its scope of eHealth.

What this might mean for CEN/ TC

251 is that the eSP collaborative, in

which it will participate, will

effectively support the take up of the

norms (standards and specifications)

that the EU requires in eHealth. The

partnership of SDO, MS, and Business

supports the National Member

Bodies and competence centres, to

provide robust implementations of

products and services for the benefit

of their own citizens for whom they are responsible and therefore have a duty of care.

Page | 10

Concepts to support

governance, coordination,

planning, delivery and

documentation in health & care

Comprehensive, life-long

health & care records,

combining data from

multiple systems

Technology-independent

services, integrating common

data and business logic in

health & care systems

HISA

EN ISO 12967

EHRcom

EN ISO 13606

ContSys

EN ISO 13940

Integrated services supporting all

record exchanges and accesses

All patients, carers,

professionals and

organizations

are fully informed

whenever and wherever

they need to act

The Concurrent Use Initiative The 3rd Concurrent Use workshop was held at the NEN premises

in the beautiful city of Delft. It was for two days, 8th-9th August.

As with the other two workshops a report was produced that

shows how far we reached and how far we still have to go. The

1st, 2nd, and 3rd reports can be found here.

This workshop was, however, very different from its

predecessors in terms of its objectives and was more focussed

on delivering a set of outputs that would explain our work and our ambition. There were 7 in all:

1. Two page summary of the Concurrent Use Initiative

2. Template for mapping the specifications in the Concurrent Use Initiative

3. The Concurrent Use landscape, positioning other relevant initiatives

4. Disposition of comments from the previous 2 workshops

5. Use Case definition: an early WG1 template

6. The Business Use Case approach for a ‘Standard Application’ of Concurrent Use

7. A possible structure for a Technical Report on Concurrent Use

A particular emphasis was on how we could make our progress accessible to others in the

community and further afield to the wider public. In the current parlance, we wished to find ways to

socialise our standards! For

example, the use case

definition from WG1 has

now been promoted in 2

FP7 projects (ANTILOPE and

Trillium Bridge) and in ISO

where a new work item is

being developed for a re-

use strategy, based on both

US and CEN’s experiences.

In keeping with this

newsletter’s mission and

theme, we specifically wish

to address the idea of a 2

page summary as an output

and show how the flyer

evolved, sparking exciting &

innovative developments.

We needed something like

the “Its about Europe, its about you” slogan produced by the Commission’s marketing people. We

were acutely aware that we were far too comfortable working with abstract concepts, models, and

architectures, to the detriment of our potential customer. We needed to explain our abstractions in

ways that did not require the interested party to become an expert in UML, and proficient at reading

large, complex specifications before they could understand the purpose of the overall work.

Page | 11

We came up with the idea of producing an A4 page flyer that illustrated our work, showing the inter-

relationships between the 3 specifications and examples of use. It would have been a single sheet

of A4, but we decided that we needed a diagram. It is good to report that the flyer has been a great

success, the diagram too! For a copy of the flyer with further details on the three featured

specifications and how they are used, see here). However, the specification triangle illustrated in

the diagram is still quite an abstract representation and is necessarily a very static one.

We felt that we needed a more dynamic presentation. The King’s Fund, in the UK, had recently been

very successful at providing an animated cartoon to show the complexities of stakeholder

organisations in NHS England after the recent reorganisation. We decided that we wanted

something similar and ‘commissioned’ Catherine Oughtibridge to represent the Concurrent Use

concept from a lay person’s perspective. She produced an excellent video for us, and her father,

Nicholas (the project lead for ContSys (see page 14)) helped with the scripting narrative.

The end result has been extremely successful, with hundreds of recorded views, and there has

already been translations made into French, Italian, and Norwegian. It has also been referenced on

a number of SDO websites, and the Joint Initiative Council intends to include it on their site too.

This was a new venture for us with using this type of social media and exploiting it to inform the

public of our work. We think it was worthwhile, but we would love to hear what you think of it as a

way forward… CEN/TC 251 Health Informatics

The next TC 251 Concurrent Use meeting is in March with a full workshop is to be held jointly with

SemanticHealthNet later in 2014.

Page | 12

SemanticHealthNet is a European Commission sponsored Network of Excellence on ‘Semantic

Interoperability’, and spans 2011-2015. It was awarded €3 million and it now comprises 17 partners

and over 40 internationally recognised experts. See http://www.semantichealthnet.eu/

SemanticHealthNet (SHN) has a number of objectives:

To leverage a clinically-driven work-plan, focusing on ‘heart failure’ to exemplify chronic

disease management, and cardiovascular prevention, exemplifying public health

To bring together globally best of breed semantic resource producers including commitment

from SDOs

To draw on a rich body of expertise from past European projects and initiatives

To maximise stakeholder engagement and resourced commitment

To have a robust business approach

To develop a scalable, sustainable, well-governed European Virtual Organisation for

semantic interoperability.

Since its start, the landscape has continued to change. For example, SHN is now in collaboration

with the Clinical Information Modelling Initiative (CIMI). CIMI has been introduced in our past

newsletters, and Stan Huff was at ISO bringing CIMI and the revision of EN ISO 13606 closer

together. CEN/ TC 251 is a voting member of CIMI, and its representatives are experts within SHN.

CEN/ TC 251 and SHN

CEN/ TC 251 was not originally involved as a partner with SHN. At that point in time, CEN/ TC 251

was re-inventing itself as a delivery focussed body. Consequently, a number of individuals from the

TC were involved and participated as experts in their own right. CEN/ TC 251’s relationship with

SHN has since changed and is now more similar in nature to the CIMI collaboration, and like CIMI, it

has a shared agenda with SHN. There is a joint SHN CIMI meeting planned for March and it is

intended that there should also be a workshop with CEN’s concurrent use initiative, later in the year.

The shared agenda is also apparent in the need and vision to develop a longer term, more

sustainable way to coordinate and deliver semantic interoperability assets. SDOs, along with policy

makers, health authorities, national competence centres, service providers, insurers, industry,

professional bodies, and academia are among the diverse set of stakeholders required to make this

happen.

SHN is a project that has two distinct parts related to its interoperability vision, infostructure for

semantic interoperable resources and infostructure for a European virtual organisation. The eSP

collaborative (see pages 8 and 9 of this Newsletter) is an initiative which shares this vision and

consequently CEN/ TC 251 wil work closely with SHN to achieve our mutual goals.

Page | 13

Updates

Is ‘time’ European? The revision of EN 12381:2005 Health informatics - Time standards for healthcare specific

problems will be discussed at the next joint CEN/ TC 251 WG1-WG2 meeting in the New Year.

The Standard communication protocol - Computer-assisted

electrocardiography

The revision of EN 1064 SCP-ECG has begun. A team of experts within CEN/TC 251/WG IV has

started the revision of the electrocardiography data exchange standard EN 1064 Standard

Communication Protocol-Computer-Assisted Electrocardiography (SCP-ECG). This standard dates

back to 1993 when it was first published. Since then it has become a national ANSI standard in the

USA and also an ISO standard with the number 11073-91064. For this reason the revision team

needs to be in close contact with the international users of the standard not to create a piece which

the other parties cannot approve.

The kick-off meeting of the revision took place in Brussels on 25.11.2013. Alois Schloegl and Paul

Rubel were elected as co-leaders of the revision project. The first thing to do is to study the extent of

the required and useful revision of the standard taking into account the available resources to the

revision work. The project team will determine, for example, would it be feasible to implement the

extensions to long-term (Holter) and exercise ECG into the new version of the standard. At the same

time the project team keeps in mind that unnecessary changes to the standard should be avoided to

protect the investments of the companies who have implemented the standard. The applied

nomenclature in the standard will be checked for compatibility with the Annotated ECG standard

11073-10102 and the normative references will be checked, as well. The SCP-ECG standard is

supported by the OpenECG community, see http://openecg.ifc.cnr.it/ for details.

ISO/ TC 215 and JIC, October, Sydney Australia This was the first meeting after the TC reorganisation had been finalised, and the subsequent business plan had been launched. As such it was the first meetings that the coordination advisory groups of the TC met to operationalize the plan. Stephen Kay has been asked to lead a task force focused on NMB engagement in particular as part of putting the communication plan into action.

Whilst there were no earthquakes to contend with as in Mexico, we did have wild bush fires that cast a smoky haze over the proceedings! Fortunately, the fires were miles away and no threat to the attendees. Standards Australia were excellent hosts and the meeting took place in their country’s Olympic Stadium complex (see picture below).

Despite the distance, there were European attendees in most groups and their contributions were appreciated and valued. Some too were able to attend ‘virtually’ via teleconference and with the help of Standards Australia’s technicians, this worked reasonably well. Two European-led projects to be noted here are Detailed Clinical models (DCM) and the System of Concepts for Continuity of care (ContSys).

Page | 14

Detailed Clinical Models (DCM)

William Goossen, Netherlands, has been the originator of the Detailed Clinical Model specification.

It has had an extended time of scrutiny as people have come to grips with this important

contribution. In the Sydney meeting, WG1 approved the disposition of comments and a resolution

was made, and accepted, to publish EN ISO TS 13972 Health informatics - Detailed clinical models,

characteristics and processes. Well done William!

System of Concepts for Continuity of Care (ContSys)

ContSys had 598 comments on its first ballot. A full disposition is being made, but the main

substantive points were presented in a joint meeting of ISO WG1 and WG3. The technical

committee was informed of progress and it was decided that the next steps should be as follows:

1. The two WGs to provide feedback on the disposition of comments circulated 2. The project team complete a candidate FDIS document for the end of January 3. The working groups review the document and provide feedback by the end of March 4. JIC members also to review the document and feedback by 31st March 2014 5. The project team revise the candidate FDIS in light of the feedback received 6. The working groups jointly review the candidate FDIS in the WG meetings in Japan 7. The committee consider the working group recommendations and (if agreed) resolve (at the plenary in Japan, May 2014) to ballot as an FDIS

There was a spurious ‘obsolete’ resolution that appeared after the meeting that will be redacted or

changed in due course. However, whilst changing some of the agreed timings, the final date given in

that resolution was for December next year, which is easily met by the above schedule.

The Joint Initiative Council (JIC), October, Sydney Australia A JIC meeting took place at the close of the ISO meeting. It was noted that DICOM had asked to join. Whereas all are supportive of increasing the membership of JIC, it was felt that the JIC Charter needed refreshing and made clearer so as to facilitate participation, and this is seen as a priority before extending the Council. There were a number of action points that arose from the ISO meeting (for example, issues around ContSys requiring specific JIC Comments) that has led to some work being undertaken to clarify how JIC can support joint initiatives in a more productive way.

CEN/ TC 251 Plenary, 26th November, Brussels The 70th Committee meeting of CEN/ TC 251 took place in its Brussels meeting centre. Considering

this auspicious anniversary, and in the spirit of the living longer, living

active EU initiatives, we regard 70 as the new 46 (at least in

hexadecimal), and we push on to the 80th (or rather our 50th!)

celebrations with renewed vigour!!!

There were 23 attendees (5 via teleconferencing); and some of what

was said is presented here. We would also like to take this opportunity

to show our appreciation and celebrate ‘new blood’, by offering a very warm welcome to Steinuum

Valdimarsdottir from STRI, Iceland, who was able to attend her first meeting by teleconference.

Another welcome attendee at the committee meeting was Lisa Spellman, who is the ISO/ TC 215

secretariat, as well as serving as the current JIC secretariat; her presence underlines the synergy and

shared interests of the CEN, ISO, and JIC communities. Lisa flew in from the States and met with

members of the TC 251 management team for dinner on the night before the plenary.

Page | 15

The New Year

As reported last issue, NEN is still examining its business case for

continuing with the secretariat in the light of reduced resources. We

wish them well and hope they are able to continue with their excellent

support. But the area of resourcing is very difficult. In a similar vein, value propositions for

standardisation are extremely important. Such propositions are key for articulating value and

thereby sustaining the role of all technical standardization work; the benefits, costs and risks are

intrinsic parts of the equation and should all be assessed from the customers’ perspective.

This important discussion within TC 251 has been taken forward by Frederik Endsleff, who is the

head of Delegation for the National Member Body, Denmark. Mr Endsleff has been considering the

current and future potential of CEN/ TC 251 within the context of global eHealth and circulated a

paper to the NMBs prior to the TC plenary in November.

From the perspective of TC 251, Mr Endsleff seems to be a satisfied customer, and is very supportive

of the role and activities that CEN/ TC 251 carries out. He seems to applaud many of the new

initiatives that we have taken in the last two years, including the newsletter! Furthermore, he

strongly believes that CEN/ TC 251 is required to maintain a regional presence and to function in

partnership alongside of ISO/ TC 215.

At this time though, he thinks it is difficult for any one nation to foot the bill and

he believes the TC should continue to liaise more with the European governance

fora (eHealth Network, Connecting Europe Facility Governance, eHealth Stakeholder

Group, ICT Standards Multi Stakeholders Platform, etc.) assuring a strong running dialogue and

linkages with EC policy and decision makers.

In considering possible roles, Mr Endsleff mentioned that NMBs would appreciate it if CEN/ TC 251

could actually lift some of the burden they felt when having to deal with a variety of players and many

specifications with little authoritative advice or guidance.

The view of the Danish NMB seems

in accordance with the present TC’s

strategy and the central place the

eSP proposal might play in serving

the community.

We are grateful to Mr Endsleff for

leading this debate and we would

welcome further comments on his

presentation).

It is traditional in such meetings to

finish business with a list of dates and venues for forthcoming meetings as part of the agenda; so too

with these TC 251 newsletters. And in closing this issue, we announce the next topic for the 5th

News Letter and provide you with the details of the forthcoming events in the New Year, so …

Page | 16

Future Events for your diary & information

18th March 2014: CEN/ TC 251 Joint WG1-WG2 meeting, at BSI, London.

19th March 2014: Concurrent Use Initiative, BSI, London

19th -23

rd May 2014: ISO/ TC 215 meeting, Karuizawa, Japan.

25th June 2014: CEN/ TC 251 plenary meeting, Brussels.

July/August 2014 (TBC): joint CEN/ TC 251 Concurrent Use Initiative and SHN workshop. 6

th -10

th October 2014: joint ISO and CEN WG meetings, Berlin, Germany.

The CEN/ TC 251 Newsletters, the TC 251 WG1 Concurrent Use Workshop Reports and other materials can be found on our web site: http://www.ehealth-interop.nen.nl/

The 5th Issue of the CEN/ TC 251 News Letter will be all about Open Standards.

As usual any views you wish to air and share can be made via our Linked-In facility or

directly via the editor or the NEN secretariat.

Contact Details If you wish to contribute, or have suggestions as to how we can improve our publications, then…

Contact the editor, Stephen, ([email protected]) for newsletter-related topics,

and the TC 251 Secretariat, ([email protected]) for all other matters.

For their contributions to our work and this newsletter, we wish to thank:

Catherine and Nicholas Oughtibridge (video) (page 11) Dipak Kalra (page 12) Christian Hay (photo) (page 13) Frederik Endsleff (page 15) Alpo Varri (photo) (page 15)

References: 1. Robert C. Ankony and Thomas M. Kelly, "The Impact of Perceived Alienation on Police

Officer's Sense of Mastery and Subsequent Motivation for Proactive Enforcement," Policing: An

International Journal of Police Strategies and Management, vol. 22, no.2 (1999): 120-32. 2. British Standards Institute (BSI publicity material). 3. John Lennon’s lyrics and inspiration from “Imagine”, 1971. Adapted; [standards] inserted.

And finally… Our last two newsletters have been ‘bumper editions’. This is partly because the 2013 scheduled

ISO/ TC 215 meetings have unfortunately been outside of Europe, and partly because there has been

so much going on in Europe to report. We hope you have found this News Letter informative and

easy to digest, despite its size! We hope too that you will now have some free time for peace and

quiet, away from the frenetic pace of our business and events, and, with the spirit of ‘Health First’,

we would wish you all a good time to relax, refresh and enjoy!

Happy seasonal greetings from all in CEN/ TC 251