ISO/TC215 vh3

Seoul, 26-30 March 2001

Report by Michael Mair, New Zealand delegate

Contents:


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Executive Summary

The March 2001 ISOTC/215 meeting in Seoul Korea was dominated by the reality of HL7 takeover of the global Healthcare Standards arena. However, the US-derived standard is itself incomplete. The urgency perceived by many nations in getting a rudimentary National EHR implementation may force them to adopt an eclectic approach, in the short to medium term. The ISO committee itself is in danger of being trivialised into a media exercise by participation of consumer groups.

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Introduction

ISO/TC215 with a Korean Flavour

This is the final New Zealand report from me on the ISO Health Record Committee.

For many months there was doubt about whether the Korea meeting would be held at all, and notification was indirect and occurred about two weeks before the conference. I knew the Access work item would be formally withdrawn, but I wanted to 'own up' to it, and to give the ISO committee a chance to move on to another way to tackle the 'Access' question in an ordered and consistent manner. I also wanted to see 'what happened' in Seoul, so that I could better advise stakeholders in New Zealand where they should look for standards in this area, and so that they might know 'first hand' where the ISO committee was at. In common with other nations, New Zealand must inevitably move to electronic healthcare records, and there is now a major national project under way to achieve this (www.moh.govt.nz/wave).

The Scene, the Setting

The beautiful Sheraton Walker Hill Hotel is on a hill overlooking Seoul, and a good hour's drive away from the 'downtown' area even when the traffic is light. We were in a real 'ivory tower', where our hosts lavishly entertained us. This included a traditional Korean feast and display of traditional song and dance. The ISO committee has never stinted itself for luxury, but the Koreans were superb hosts.

Many of the delegates already knew each other from earlier meetings. This collegiality was reflected in the close-packed seating in the meeting rooms. A new addition to the delegations was observer representation from China. This was truly a 'global' meeting, but great swathes of the world were unrepresented, including the Indian subcontinent, South America, and most of Africa. South Africa was represented, and Robert Mayes, who has left the US Healthcare Funding Agency, is now seconded to Zimbabwe by the US-based Center for Disease Control.

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The Work Group One Meeting

The first meeting of this group was really packed, with about fifty people in a small room. First, Canada's 'Country Identifier Standards' were discussed.

Country Identifier Standards

This was one of the three work item from this group that had been at all fully explored, and Don Newsham, the project leader, argued that it was not as trivial as some had supposed, because the allocation of unique identifiers on the Internet was filling up fast. However, the US delegation head Peter Waegemann informed us that the US 'TAG' (the American Electronic Health Record Policy making group) had rejected it. The work item is going for ballot in April of this year, and might then become an actual standard.

Requirements for an Electronic Health Record Reference Architecture

Next discussed was Australian Peter Schoeffel's 'Requirements for an Electronic Health Record Reference Architecture.' This document, withdrawn in Tokyo, was re-introduced in Seoul and contains over 700 items. An example is 'Security', with the subsets: Authentication, Author identification, Data integrity/non-alterability, Non-repudiation, etc. It contains the 'universe of artifacts' (models, documents, designs) that enable 'architectures' for health information. It is in this repository that our Access work item is likely to end up, so it is worth bearing in mind, but as the Canadian delegate Richard Alvarez commented, it is hard to understand the utility of this exercise. I asked Peter whether such a classification does not duplicate the other 'ISO' repository of concepts in the 'General Domain Model', and I noted Peter Waegemann nodding in emphatic agreement with this notion.

The General Domain Model

Don Newsham from Canada also asked about the relationship between Peter's 'requirements' and the General Domain Model. This Canadian proposal used a 'Zachman framework' as a 'model of models' for healthcare (www.zifa.com/frmwork2.htm). Such a framework, in which models can co-exist, is not in itself a model, but more a map where models can be located along the dimensions of 'what', 'where', 'who', 'when', and 'why', and also in the dimension of 'specificity', from the most abstract (global healthcare), to the most specific (some actual data instance). Such a framework would act like a navigation device, allowing models that address related fields to be at least be set up in relation to this limited external grid. I reported on the Vancouver GDM meeting.

Models in Social Science have the peculiarity that they create the very phenomena that they then analyse. The philosopher of science Thomas Kuhn explored it in his book 'The Structure of Scientific Revolutions', and concluded that Social Science was 'pre-paradigmatic', which was the state of natural science before Newton, when the competing theories of the alchemists similarly each defined the territory of their craft.

The plethora of models and their ensuing behaviours that are active in global healthcare at present 'talk past each other', just as the alchemists did, and the competing paradigms of social science still do. They are hard to contemplate in their diversity precisely because moving between them often involves a significant change in mindset. There can be no containing model for such diversity, because each defines a reality that tries to be selfsufficient and self contained, which is another way of saying that they do not interoperate.

The approach has many benefits. It:

  1. Expresses the view that ALL phenomena that we deal with are models, including medical practice.
  2. Recognises that models can change in time.
  3. Recognises that competing paradigms talk past each other, do NOT translate but can co-exist.
  4. Sets them out, so perhaps they could change in time in relation to each other.

Contemporary cultural products will change in time, and indeed they must and are changing. By providing a locator grid and navigation tools, the General Domain Model might act as a catalyst for this 'computation' of mutual adjustment. Peter Tresseder's business plan for global healthcare will be facilitated by it.

Discussion on this model was generally positive. A delegate from France suggested that there was a need to reduce the number of standards and pre-standards going for the same territory. Robert Mayes said it was rare to find anyone who manages resources asking this kind of question, but that this or something like it could be a useful tool. Peter Williams pointed out that we lack a 'political model' to guide investment. He said that there was a multiplicity of ventures and perspectives, and this framework might help coordinate them. Tetsuro Kiyotani thought that this kind of framework helped to intertranslate cultures. The delegate from South African thought it necessary for the business plan for ISO. There was general support for the value of the work.

Alvarez from Canada asked 'please no more models', and thought that the concept was important for the TC, but perhaps it would not move to a standard, being more a resource management tool.

Gary Dickinson from the USA said he had worked on the Zachman framework concept with ASTM, and that it was 'where rubber meets the road.' An Australian delegate said that he would like to see the mapping of data dictionary elements to the model, and Stephen Kay from the UK thought it important that there was grounding of the lowest levels of the framework in things that actually work, and the framework could be considered to be connecting the conceptual worlds to the physical, or physical to conceptual. Don Newsham acknowledged that more work needed to be done on how to enter existing models on the framework.

Such an accord, an agreement to agree, has repercussions in other fields of human endeavour. At this time, when we need to set up the infrastructure for global survival, such an enterprise might resonate into global modelling generally, and point the way for other needed accords over the next few decades.

The Japanese Reference Enterprise Model

Kanji Nakai introduced this. He said that whereas he might have proposed it before as a General Model for ISO, he now recognised that there were cultural differences expressed in local healthcare environments. There might be common tools, but different cultural definitions might mean that the Japanese model might be local rather than a global in its provenance.

He said there was an understanding of the General Domain Model now. He said that it might permit the development of local enterprise models and it might promote harmonisation of enterprise models. He said also there might be harmonisation among key stakeholders such as HL7, CEN, OMG, ASTM, etc.

Details of the Japanese initiative can be found on www.jahis.gr.jp/english/index.htm.

The Access Work Item

I went to the Seoul conference partly to find out what would happen to the matter of access after the rejection of our work item by WG4. In the months and weeks leading up to the conference, I was uncertain how to proceed with it, since WG4 had refused to work with us on it, although it was still 'on the table'.

I had circulated an 'access manifesto', suggesting that whatever was agreed should be real (ie, effect interoperable access) yet permit difference practices and behaviours according to culture and circumstance. (See Appendix One.) I suggested that finance should not be a criterion for exclusion from ability to comply.

At the conference, I traced the history of the Access work item. In Sydney, some delegates had doubted that it would be possible to have an ISO access standard:

I argued then that the 'ownership' concept as a regulator of access to electronic health records might be deconstructed into a network of rights and obligations surrounding records. This idea subsequently got a lot of support, and with the help of other delegations, the 'ownership' concept was deleted from the work item definition at the Tokyo meeting.

The problems that we ran into in progressing the work item were several. They included:

We thought we should be trying to identify implementable concepts, but we were subsequently told that we should have been concentrating on 'policy'. However, 'policy' is the very thing that cannot be standardised, or 'normative'.

The concepts that we explored recognise the importance of the concept of 'role', and 'role-bound access control'. We suggested that sets of roles should be self-defining and autonomous, and this would allow differences in practices and behaviors to be expressed.

After the Vancouver meeting, and the rejection by WG4 of the approach we had taken, it appeared that we were left with a 'mission impossible' to continue with the work item.

Comment: If there is to be interoperability of access, we think there will need to be an actual shared technique. In the 'manifesto' that was circulated before this meeting, in addition to the requirements, which we expressed in the access paper (and which are widely shared, including in the PKI paper), we suggested Accessibility and Interoperability as additional 'requirements' beyond the standard list. (See Appendix One.)

The standard should not only 'work', but should be widely available, to different record systems using different technological levels. It should be responsive to different cultural and ethical concepts and definitions. It should not 'lock out' half of the world, simply because they cannot use complex technology. In particular, open source solutions for electronic record keeping should be able to fully participate in the interoperable global 'record'. We still maintain that standards work in this area should lead to the adoption of a shared 'technique'.

'SOAP'

Information is recently available on the 'Simple Object Access Protocol' ('SOAP'). I suggest that the ISO committee explore the adoption of this protocol for mediating access. It is very similar to the 'access object' concept that we developed. It is 'open source' and freely available, and might do the job. It is being considered for adoption by the W3C (World Wide Web Consortium), and is also to be used by Microsoft for its new web environment (See Appendix Three.)

At the end of my exposition, I returned to the simple ancient poem that had accompanied our early requests for collaboration on the access proposal:

He who knows not and knows not he knows not
He is a fool, shun him.
He who knows not and knows he knows not
He is ignorant, teach him.
He who knows. and knows not he knows,
He is asleep, awake him.
He who knows and knows he knows
He is a wise man, follow him.
(Anon.)

I again pointed out the Boolean nature of these options and suggested, as we had in the Access paper, that they form a core set of 'final common pathways' in access control. (See www.health.nsw.gov.au/iasd/imcs/iso-215, user name 'wg1' and the password 'berlin'.) Superimposed on this there should be a culturally relativist generic access control matrix, and that this should be 'empty' of itself, but populated by culturally derived ontologies.

Discussion

Robert Mayes straightforwardly said 'No, that is not enough.' The task was meant to be to explore some kind a framework in which you could describe different roles and responsibilities around access. He said that somehow we got sidetracked into these implementation issues, which was why the work item was not successful. The next day when I again asked him what he would have done, and he said he was remote from that kind of anthropological literature now, but he remembered there had been discussions about classes of relationship, which might make some kind of a framework.

Later, on discussing the matter with Ken Toyoda, he again mentioned this diffuse concept, and I note that in the final resolution put by WG1 to the ISO plenary on the subject of our work item, it was stated that some more work on the matter 'might need to be done in the future', presumably again to identify some sort of a universal matrix.

I disagree with this notion. The outcome of the anthropological enquiry is not to identify a minimum set of access concepts, or a generative matrix of access rights and obligations, but rather to recognise that the space in which access rights are defined starts off empty. All through the argument, I have emphasised the 'games theory'-like nature of interdependent notions (ontologies) that define access rights among different cultural and political groupings, and that games cannot exchange pieces because they owe their identity to each other within each game.

I pointed out that we had not had collaboration from WG4, and therefore that it was unrealistic to continue with the work item, which in any case was beyond my personal resource. I said that we were probably going to try on the ideas in New Zealand, and in a later conversation was able to point out that one student masters thesis in Otago has already been completed on the subject, and another is under way in the University of Auckland.

Gunnar Klein suggested that access could be about 'sending' information, and about people deciding when to send. He said that there need not be an actual technique involved.

I disagree with that notion. It is certainly the case that people could regulate the exchange of messages between healthcare entities on a simple 'decide and send' basis. However, such a technique of regulation could never give 'browsable' access, and thus does not actually engage in the possibilities and difficulties of the new technologies. I made more progress with this at the WG4 meeting.

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The Work Group Four Meeting

The PKI Infrastructure Documents

Lewis (Australia) and Fraser (Canada) presented the PKI infrastructure proposal. They said that ISO terms were used where possible, and where they were lacking, then CEN, or ASTM was as a source of definitions. Failing that, they then went back to textbooks. They said that a certificate binds a public key to a distinguished name, and that the private key binds to the individual. They noted that there was still no implementation of attribute certificates. They said that the technical form of the directory attribute extensions would allow for classification of consumers. They said that the X509 version 3 already spelt (?this) out by IETF Subject directory attributes. They suggested we want one healthcare specific identifier not multiple. It was pointed out that attribute certificates had been included in the PKI specification at the Japanese delegations request (they had been previously excluded).

There were various written responses to the documents discussed, including a long representation from the German team, which I gather included Bernd Bloebel, and occurred in the presence of the German WG 5 convener. It was generally agreed that the proposal should go on to the next stage, consideration for adoption as a technical specification.

The Access Discussion

First, I enlarged on the concept of the 'self-defining set', and pointed out that access ontology was about self-contained cultural worlds. I suggested that negotiation between peers would be by private treaty, and that it was only the infrastructure that would be shared. I pointed out the benefits that this would bring in the way of research availability of material, as well as a conduit for records in emergency situations. I pointed out the similarity of the concept to the CEN distribution rule, and that it was something that would travel with record components, and be definable right at the clinical interview.

I was able to introduce the group to the 'SOAP' (Simple Object Access Protocol) concepts that had been worked up by Terry Paddy (see Appendix Three). I was able to point the group to a paper from the HL7 site that tried applying the SOAP concepts to messaging using components of the CCOW model. The participants had mostly heard of the 'SOAP' idea, but were unfamiliar with its details.

Gunnar Klein at that point gave a brief presentation on the CEN 'distribution rule' concept. This was an elaborate and detailed model, presented in UML diagrams. It relates to the other components of the CEN 'extended architecture'. Lori Reed-Forquet (USA) seemed genuinely interested by this time, and I pointed out that the access concepts could just 'piggyback' on the PKI infrastructure work. At that point, there was general enthusiasm from the group that the access work should be the next thing that was dealt with now that the PKI infrastructure was delivered. Gunnar asked me if I would be a driver of that subgroup. I declined, explaining that regretfully I would have to withdraw from personally attending meetings and Gunnar noted 'You are only an e-mail away...' The Secretary took my three documents on the SOAP concept for distribution. Perhaps they will be on the table when the matter is discussed in London in September 2001.

Later I was told that Peter Waegemann had said at the HOD pre-meeting that it had not been fair for the ISO committee to 'lead me on', the implication being that I had been given an impossible task. I think the exercise has been valuable, not least because it may have helped the committee with its processes, but also because in the course of it I think we delivered an important batch of concepts that may, in fact, be used for access control at least in New Zealand, and may perhaps have global relevance. The text of the plenary session resolution suggesting withdrawal of the work item mentioned the 'many important concepts that had been discovered' (my emphasis) in the access work.

I venture to suggest that it is almost the only original work yet done on behalf of the ISO committee, and that with the 'takeover' by HL7 (see below), the committee henceforth will have a role only in 'rubber stamping' HL7 standards as ISO ones. However, the simple idea - that 'role for access' metadata should be applied to data collected at point of care - might be adapted for use with the HL7 concepts as well, such as the CDA (Common Data Architecture) templates. It would probably be put in the 'headers'.

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Other Miscellaneous Pieces

Image and marketing of TC215

Alvarez from Canada spoke He said we should give consideration to the image and marketing of TC215. He said in the creation of any group there were four stages:
forming, storming, norming, performing
and he indicated that we were now at the performing stage and therefore needed marketing. He said that many or most developers and agencies would want to look to ISO rather than making their own standards.

EHR

Bob Mayes spoke and said that we were not poised to move toward a unified end point at this time on this subject. Mr Waegemann agreed that is a concept with many components. Mayes emphasised the importance of work being done outside ISO - eg, on web security.

Schute

Prof Shute addressed the meeting on behalf of WG3. He said the task was not developing an ISO terminology, a standards of standards. He said WG3 planned to withdraw quiescent work items. Instead, they would concentrate on distribution formats for terminology - eg, codes, terms, synonymous translations relationships coding rules description logic.

It was clear that this was a formal withdrawal by WG3 from standards-setting work except in the matter of formats. Standards development in this area will then continue chiefly in Snomed, which now appears to have a monopoly. All of the 'original work' that was promised for WG3 has been abandoned, and the work group demoted to a rubber stamping device for standards developed elsewhere.

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Brief International Review

CEN

Gunnar Klein summarised what he felt was the relationship to the ISO committee. He said that for the first time since the meetings started, he felt that the Committee had finally taken off. He said this meeting a turning point, and that now most of focus will move to ISO. It would not be tied to financial strength.

Historically, he noted that the European work began in 1990 when there was no international work. He pointed out the increased movement of people between countries, and that for example forty million visit Spain each year. There was a real need for movement of information across borders.

He said he was happy that we should all now follow the HL7 work for messages. He pointed out that it had originated in CEN.

About the relationship between CEN and HL7, he said that he did not want the old HL7 as ISO standard. By this he meant Version 2.x and its variant up to 2.4 (?), which are the current de facto standard for the US, and increasingly Europe and Australasia. Instead, he said we should concentrate on what we want for the future.

He said it should involve the joint work of the best experts in the world. He said that it was the same as the way other industrial products need standardisation. He said there were emerging requirements for cross-border communication - not a big thing yet today. He hoped that in time more and more work could be transferred to the ISO area 'which is a place where we all meet.'

The reality is that most CEN committee workers now attend HL7 meetings and recognise that the growing edge of standards development is now in or as part of that forum. Informed sources say that funding for CEN committee work appears to be drying up. Few countries or enterprises appear to be actually using CEN concepts, apart from Denmark. The CEN 'extended architecture' in any case appears to have been more in the nature of guidelines rather than a standard, for which compliance and conformance could be tested.

However, CEN did have crucial input into current HL7 work. CEN messaging concepts were borrowed by HL7 earlier on (ref RIM Dec '99 paper), but this work has now moved beyond them. The CEN distribution rule concept (Ext Arch Part 4) remains on the table. While this concept is in fact extremely valuable, the way that CEN has developed is dependent upon the rest of their Extended Architecture concept, which has not been widely applied.

The US Scene

Some important points are

It does appear that HL7 has become the forum and the standard, and so it is essential to try to understand the Reference Information Model (RIM). Jane Curry has claimed that it has been shorn of all commercial and scheduling material and is now therefore universal. (See Appendix Two.)

Canada

The Canadian Health Information Development is probably the most significant of all the National Players outside of HL7. The Canadian Data Model is a simple atomic concept not unlike the Health Event Summary. It is where the 'tyre meets the road', to quote from Jane curry, who works in Edmonton. They have also developed a Health Indicator Information Framework that will probably be the basis of the ISO standard, and this was also presented at the WG1 meeting in Seoul. They are keen participants in HL7, and relating to them in this regard is the same as relating to HL7. In particular, their 'data capture mode' will presumably be expressed in the HL7 CDA concept.

Finland

Mr Pekka Roustinalin told me where Finland is at with its implementation of an electronic health record. They are establishing a network of regional servers, and plan probably to use the HL7 CDA unit architecture for their basic Health Event Summary. Each server would have a dictionary of local data elements. He thought that the Access question would have to be done always by informed consent, and appeared to seriously take on board the option I told him of default consent through participating in the system, and access regulation with role metadata. He appeared to be interested in the idea that a 'search object' might look for a match with record metadata, making a dictionary of referents. He was returning early to Finland to take part in a meeting with politicians and "technos" to implement just such a system in Finland. He said that centralised registries of any sort were at present illegal in Finland. He mentioned the role of 'smart cards'. He said we should keep in touch, and took copies of my SOAP papers. He also said that he did not think anything implementable would come out of the CEN records work. I think we should keep in contact with developments here, perhaps including a site visit by a New Zealand representative.

The UK and Ireland

The UK would appear to be in some health informational disarray at this time. The Read code fiasco has left them without a substantive contribution of their own. As one UK delegate said, they do not at present develop standards themselves, and the eclipse of CEN has left most of their key players going to HL7 meetings, often unfunded. It is now freely conceded that standards development is occurring at that forum. The UK GEHR work is continuing at University College Hospital, and I understand that there is an interface for 'legacy' systems, with an 'object dictionary' developed. It does appear that as with the Australian project, there is a lack of funds, and the relationship to the Australian effort remains obscure. There is also the 'Synex' project which is a collaboration of Trinity College, Dublin, with Norway, and this is also exploring XML as a transport format, and has an 'object dictionary', which will be an important source for a possible global 'object dictionary' (www.gca.org/papers/xmleurope2000/papers/s32-02.html).

China, Japan, and Korea

The Japanese healthcare system is different from Western ones in some of its key concepts, particularly over the use of in patient stay as a means of managing geriatric and mental health problems. The age structure of the Japanese population has implications for present practices that mean that they have to look at alternatives. In Japan, Chinese medicine is the first recourse for day-to-day aliments for the majority of the population. It was striking how at the Korean meeting, the Western nations completely monopolised the conversations. I got the feeling that the Japanese and Koreans were looking for a 'way in' to the discussions, and that we had really helped them by making it possible to talk about cultural differences in practices and behaviours in healthcare. I got the feeling that, like everybody else, they were finding it very difficult to make sense out of what was going on.

As the Chinese also begin to engage in the ISO process, we find a serious challenge mounted against the ubiquitous US concepts, or at least the recognition that they need to be shorn of US cultural and economic assumptions. It is of interest that Taiwan may be developing a Health Event Summary concept similar to the one proposed for New Zealand, within an HL7 environment (Ed Hammond, personal communication). Ken Toyoda also told me that these three nations were collaborating on developing electronic record keeping for Chinese medicine, and would meet again to discuss it at the next ISO TC215 meeting in London in September 2001.

Australia

Others in New Zealand may have a much better idea of the 'state of play' in Australia.

GEHR was strongly represented at the ISO conference (www.gehr.org).

So why don't we join in? Peter Schoeffel who energetically represents GEHR as part of the Australian delegation, said that New Zealand would be better putting its money in the bank, rather than invest in the Health Event Summary concept at this time. He clearly feels that money spent on GEHR is money well spent, and I told him that his proposition appeared to be: 'feed my horse and it will take you to heaven'.

I later asked Ed Hammond about it, and he thought that the notion that clinical concepts should be templates was interesting, but the thought the GOM Eiffel kernel would be 'hard to implement'.

It is not yet clear whether the architecture development could occur without adoption of the Eiffel kernel. The archetypes themselves may have great value, but we want to know how they could be expressed or conveyed using HL7 technology, which appears to be becoming the standard in all other areas. We need to understand what HL7 themselves are doing about clinical concepts, and my conversation with Ed Hammond suggested that this is a very active area at present. Ed mentioned that Peter had talked of a $5 million dollar project he was organising. Clearly we must monitor this group.

HEALTH ONLINE is the organisation set up to implement the 'Health Event Summaries' suggested in the 'HINA' (Health Information Networks Australia) report. Health Event Summaries are a simple concept that would summarise every health event in a standard format. The latest update on the progress of Health Connect is from January 2001 (www.health.gov.au/healthonline/update0101.htm).

It says that in the meeting in July 2000, ministers asked for a more vigorous and consistent approach to communicating the benefits of HealthConnect to industry, consumers and providers. It also suggested that a stronger emphasis would be placed on issues relating to privacy.

"Health Ministers are unanimous in their commitment to getting the privacy issues right. The long-term success of HealthConnect will rest on the development of a robust and effective privacy framework trusted by consumers and providers alike, prior to implementation of the network."

It does appear that Australia is in the same place as us with this concept, but that the HealthConnect organisation is at present much influenced by proponents of GEHR. We may be freer of this commitment, and thus able to devote ourselves more singly to development of the Health Event Summary network and its Access System. We may also be able to be more eclectic with sourcing the 'data dictionary' that we need.

Summary of Nation Reviews

HL7 is becoming the de facto environment for the development of Health Information Standards, and may shortly become the official ISO standard.

The role of GEHR remains problematic, but may have a place in collaboration with HL7 in medical concept development. However, investing in this process might be best left to other agencies.

Finland are well up with the play and are exactly where we are, in planning a national network of regional servers exchanging templates. They are technologically very sophisticated as well. We should try and establish formal links with them.

Other European nations, including the UK, appear to have hit a period of 'doldrums' and their activities have become dysfunctional in their own progress toward electronic medicine. There are suggestions that the UK NHS is trying to develop or acquire clinical decision support software to achieve clinical governance, and establish prescriptive care pathways based on 'best practice', but their expectations in this regard may be unrealistic.

The Australian 'HealthConnect' initiative would seem to be our closest natural ally in developing the Health Event Summary network, and might well collaborate with us.

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The HL7 Takeover

I was privileged to witness an event which must be rare at international meeting on healthcare; a direct power grab by one of the 'big name' participants. Ed Hammond may well be right in his assessment that a complete HL7 takeover of the 'means of production' of health information might have beneficial consequences. As Mr Hammond himself said, 'one cannot be two', and that a world standard should be a singular set of practices and processes, not many sets.

However, the way the putsch came about was pure street theatre. We should have guessed that there would be an explosion of some sort. In a document distributed by the HL7 organisation to members before the ISO meeting, Mr Hammond had admitted that progress in WG2 (the messaging work group) had become an HL7 outreach to the extent that many European and Australian delegates had ceased attending ISO meetings, because they saw no point in meeting the same people to go over the same material twice.

At an earlier session, there had been a fracas over the relationship between ISO and IEEE (the International Electronic and Electrical Engineering group). They were apparently being unified, through a pilot programme, but CEN chief Gunnar Klein was unhappy with this process. The meeting was adjourned while they sorted it out in camera, and then a smiling Mr Hammond came back to say that it had all been a misunderstanding. Later he returned to the relation between ISO and IEEE as an established reality.

In another previous address, Ed had made the case for a formal liaison between the ISO committee and HL7. He had said it was often not clear which hat he was wearing - HL7 or WG2. He declared he was 'Ed Hammond World Citizen'. He asserted that there was an immediate need for messaging and communication standards.

He said there was a better understanding of user needs now, and pointed out the growth of the international vendor market. He said that resources were limited for standards development work, and that it was an expensive process. H said there was duplication of effort by the same people. He stated that standards are merely a means to an end not the end itself. The new ISO business plan prioritises use of existing standards. Our accomplishments would be measured by what we do with those standards.

The HL7 position was that they were interested in pursuing a relationship that would enhance the sharing of standards but preserve the value of the standard to HL7 and its constituencies. HL7 is not motivated to become the producer of ISO standards but recognises an obligation.

He pointed out the changes in HL7 with its international affiliates. There were sixteen countries affiliated, and two in the wings, with interest from several others. He said that three nations have adopted HL7 as their national standard.

He said that HL7 's first priority is to its members, including the international affiliates. He felt the need to protect the integrity of the standard, but its financial basis would benefit from having ISO adopt HL7 standards. Barriers will be removed for the rapid adoption of the standard. ISO would benefit by not having to develop standards that are already in widespread use. ISO's role could be to insure the standards are responsive to the needs of the international community.

The risk of this course might be that we might not resolve or accommodate disagreements, and that the standards would not be accepted.

'But what are the alternatives'? he asked. He said that anything that is different is different, that the standard would be 'one' not 'many'. He wanted to put a resolution - 'That the meeting support the creation of an ISO/HL7 relationship similar to that between ISO and IEEE.' Then endorsement would be conveyed to the ISO TMB and ANSI.

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The 'Street Theatre'

Ed returned to this suggestion at the closing plenary session. He pointed out the special relationship between ISO and IEEE. He said CEN had its Vienna agreement with ISO, which made some CEN standards into ISO standards. He said that HL7 was owed the courtesy of such a relationship with ISO. He said there was an ambiguity in the relationship between ISO and HL7. He noted that some countries wanted HL7 standards as ISO standards, and some did not. He now wanted a sense of the mood of this audience about whether HL7 should prepare a formal approach to the ISO (managing body) to set up such a relationship, a similar relationship to ISO as IEEE.

This was strongly opposed by Klein, who said we should not make a resolution on this matter in this meeting.

Waegemann protested that HL7 is a reality, a big player like ISO. "Isn't it positive that it say it in advance so that we can discuss it in advance?"

Hammond insisted that such a relationship was necessary to protect the intellectual property of HL7.

A French delegate said it was a very important decision, and they would have to discuss this at a national level. They said it was different situation with IEEE. The insisted that they were not empowered to decide at that meeting.

The UK delegate head thought that the proposal might make sense, but he did not have the information to decide then and there. A formal proposition should be made and discussed at the August meeting.

Alvarez from Canada also though there did need to be a better defined position put forward, and wondered if the proposal would impact on WG2.

Ed Hammond replied that he was trying to set up a process, and that it would not affect any project. He wanted a sense of the kind of direction we should take 'from this group'. He said there were issues that need to be dealt with, and that it was a courtesy, at least to give him a message to see where we are going. Is it a direction that HL7 needs to put work into?

Chairman Peter Tresseder asked "Are you talking about HL7 standards becoming ISO standards?"

Ed repeated that he wanted a feel for the mood of this particular body. If positive, would prepare a document.

Gunnar Klein asked whether, if approved, would HL7 then contact the TNB before August (the date of the next ISO meeting), thus creating international tension. He said it was not the issue that we must have a relation with HL7, but whether this was the proper procedure. The implication was clear that if Ed went ahead and contacted the TNB before August, it would make the ISO/TC215 committee process irrelevant. A little shiver of fear went around the room.

The UK Head of Delegation again repeated that his concern is much the same as Gunnar's, which was that we did not know what we are agreeing to. If HL7 went to the THB, it would end up with HL7 versus ISO. Presumably he meant 'this group', since Ed would be bypassing the group if he went straight to the THB.

Ed repeated that he wanted HL7 to have the courtesy that other organisations have had.

Canada tried to defuse the issue by saying it was on the agenda already, and therefore did not need a resolution to put it there at that time.

France protested that it was like giving HL7 a ... she looked for the word, and somebody suggested "Carte blanche...?", to general merriment. She affirmed this, "We cannot give HL7 a carte blanche."

Ed Hammond forced the vote. For many delegates, it seemed like voting for HL7, or being cast off as part of the unborn of history. Ed Hammond herded the committee over the brink. The UK, Sweden, and New Zealand abstained, France voted against, the rest went along with it, and a simple majority passed the vote. The de facto reality had become confirmed, and I left the meeting at that point.

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Conclusion

As things happen, events conspire to produce outcomes, which, with a little push from some of the participants, can be more like some contributors intended than others. There are many conspiracy theories surrounding the ISO TC/215 process, and some may be partly true, yet the process as it develops is never quite as had been foreseen by any of the participants.

I had an opportunity to discuss the HL7 takeover with the WG5 convener, from Germany. He confirmed that it was true that HL7 committees had become the place where standards work was being done now. He said that 'it did not matter, it is good.' We discussed the Health Event Summary concept, and I suggested that these could be HL7 templates of some sort; a concept that he agreed was appropriate.

On the positive side, the HL7 takeover might mean the emergence of strong and homogeneous standards for healthcare communication. However, this view may prove superficial. There are dangers in this situation.

I asked ken Toyoda whether he thought that this might be happening. He thought that the many small vendor organisations in the US would never allow it. Also HL7 material often specifically declares that is not partisan, and there is a believability about this from meeting some of the key players.

However, it was heartening to see Peter Waegemann's next records spectacular is being held in Malaysia and will feature traditional medicine. It is good that the commercial records market is driving home the insight that 4.6 billion of the world's 6 billion people live in developing or 'under resourced' lands. He also points out that seventy percent of the medicine that is delivered in the world is 'traditional' in the sense of non western, and that only ten percent of it has access to the kind of full-on technological medicine that electronic health records are developed to deal with.

Trying to go with HL7 is hard because their RIM model and its interfaces are not stable. It may be committing all nations to a certain path, which then proves empty. One hopes that the medium is not the only message here.

However, if we 'seize the moment' and try to work with HL7 as they complete their RIM and its interfaces, we may end up with something we could use. I suggest we now try to engage with them in developing the tools for a Health Event Summary network in New Zealand.

Said Alvarez, as I puzzled with him about Health Event Summaries and their SOAP wrappings, 'It is an enigma wrapped in a conundrum.' Hopefully the matters discussed in this report will become less obscure in the near future.

Mike Mair
New Zealand delegate
15 March 2001