The following e-mail was widely circulated among the Australian Health IT Standards Community last week. (Note ETP stands for Electronic Transfer of Prescriptions and ATS Australian Technical Standard)
From: Vincent McCauley
Sent: Thursday, April 18, 2013 5:59 AM
To - IT-14 Participating Members and Others
Subject: RE: Electronic Transfer of Prescriptions ATSs - IHE Australia votes NO to publication - objections and reasons follow
Dear IT14 Members,
We have been asked to approve the ETP ATS X 6 specifications with one week notice.
For the majority of IT14 members who have not seen these documents previously, that involves review of more than 1200 pages developed over 2 years.
This is unreasonable haste especially given that ETP is a high risk eHealth area and that the ATS's do not directly leverage existing implementations or international work.
To help assess this request for publication the following may be useful.
1. Has the process and does the specification comply with Australian International standards obligations and good standards practice?
Australia is a signatory to the World Trade Organisation Technical Barriers to Trade agreement – see:
The following extracts are relevant to Standards development and the current conduct of Standards Australia with respect to IT14 and IT14-6-4:
“Government officials of parties to the dispute shall not serve on a technical expert group. Members of technical expert groups shall serve in their individual capacities and not as government representatives, nor as representatives of any organization. Governments or organizations shall therefore not give them instructions with regard to matters before a technical expert group.”
This requirement was regularly not observed by NeHTA, DoHA and DHS/Medicare officers at the IT14-6-4 ETP meetings.
Government officials overrode consensus technical positions on the basis of "policy". This issue was raised by the committee and Chair with the Standards Australia management but resulted in no action.
“Members shall ensure that technical regulations are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade.”
Adoption of the proposed ETP specification will mean that standards based ETP products developed in the majority of the world will not be able to be used in Australia
“Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems.”
The Co-chair of IT14-6-4 has regularly participated for some years in the IHE Pharmacy committee, made excellent contributions and the IHE ETP content specifications have subsequently incorporated Australian requirements. The IHE CDA documents for prescription and dispense are mature international standards first published by IHE International in 2010. These specifications and the associated exchange mechanism, have been widely implemented. IHE is a full International Standards Development Organisation, member of the Standards JIC and liaison A member of ISO TC215.
Despite requests by IT14-6-4, no documentation has been provided describing why the international standard could not be adopted or at worst, adapted.
“With a view to harmonizing technical regulations on as wide a basis as possible, Members shall play a full part, within the limits of their resources, in the preparation by appropriate international standardizing bodies of international standards for products for which they either have adopted, or expect to adopt, technical regulations”
Australia has fulfilled this obligation but this resource commitment over a considerable time will be discarded by continuing with a local specification rather than adopting an international one. It calls into question the rationale for international standards development participation.
2. The IT14-6-4 committee spent considerable time preparing an impact statement which highlighted a number of serious issues with these specifications. The issues raised remain unaddressed.
This impact statement should be provided to IT14 to aid in considering whether the impact of these ATS's will result in net benefit which is a requirement for any new Standards Australia publication.
3. Is it safe?
The IT14-6-4 committee requested a clinical safety report from NeHTA but this has not been provided.
Is any information on test implementations available?
3. Is it necessary?
No justification for this work was provided in the initial project proposal statement provided by NeHTA.
Most sections of this mandatory documentation in the SA standards development process were blank.
The project proposal statement was not seen by the Committee for many months and when provided led to the Committee's work on a full impact statement.
The current ETP infrastructure is well-proven and now provides all significant functionality that was used as the justification for a new standards specification.
The impact statement discusses this in detail and was intended by the IT14-6-4 committee to be made available to IT14.
4. Is it competitive with other standards?
There is an existing HL7 V2 Australian Standard for ETP which has been implemented as part of the current ETP infrastructure.
There is an existing IHE ETP standard which would operate with our national PCEHR architecture and has been implemented across Europe.
5. Is it aligned with other similar National specifications?
The specification for both content and transport is different to that in the MEDView project which is to become the national medication repository.
The content is also different to the CDA dispense document being developed for upload to the PCEHR.
A motion in IT14-6-4 to separate content and transport/storage specifications was not permitted to be voted on by the technical Committee.
These issues require discussion and answers.
Given the timeframe allowed for consideration, IHE Australia will vote "Objection" until such time as further information and documentation is provided and an appropriate discussion forum takes place to consider process and other issues with this critical set of ATSs.
Regards
Vince
Dr Vincent McCauley
Chair, IHE Australia
Member IT14-6-4
----- End E-Mail.
That someone of the proven capacity and competence of Dr McCauley feels it necessary to “object” in such clear terms to both the process and content of a draft ATS to me reflects a wider problem. That is that there are simply utterly inadequate governance processes for the leadership and rational development of e-Health in Australia.
Let me be utterly clear in saying that until this broad issue is properly resolved we are going to see more and more a failure to achieve the objectives e-Health sets for itself.
Anyone who has been involved in e-Health in the last few years will be aware of the attempts by NEHTA and DoHA to railroad and subvert the consensus model of E-Health Standards setting with ‘Tiger Teams’ , committee stacking and the like and the effects that has had on the morale and commitment of the volunteers who contribute to what used to be working process. Ultimately this has led to a good number of valuable members being sidelined or just giving up in disgust.
This e-mail is just the tip of a festering governance iceberg and a boil which needs lancing. Without some real efforts restore / initiate proper governance and to re-empower the Standards Australia volunteers and put the clinical and technical experts back in charge (rather than the politically driven bureaucrats) of our Standards processes I predict little real progress for the foreseeable future.
David.
6 comments:
Truly gobsmacking!
Should DOHA executives be making decisions about ehealth standards and how they are managed, given that their performance contracts depend on projects (PCEHR and MedView/ETP) with short-term political deadlines and targets that are easier to meet if they themselves take shortcuts and/or ignore standards?
DOHA also fund the IT14 program of work to develop and implement standards, and they pick and choose which standards projects are funded or not. Will DOHA be tempted to prioritise and/or ignore standards work that does not further their own objectives (or those of the consultants advising them to buy their solutions and services?).
Of course DOHA will fund work that meets their stated objectives. Otherwise, why would they have them? As for whether their short term objectives are in any else's interests, well, welcome to a democracy. Business as usual...
Hmm. So Vince quotes that members of the standards body should act in their individual capacity, and not their employing organisations. And then says "IHE Australia will be voting no".
Any chance that Vince's commercial interests are influencing this? Any chance that using the international standard (licensed by IHE) would have a financial outcome for Vince?
Using the international standard from IHE would probably have a negative outcome for Vince - more work for not so much more money. IHE owns the specs, but the are used free from financial charge.
The thing with IHE specs is that the input that the purchaser - the government - has is quite limited compared to the existing ETP specs. If you're a vendor, that has obvious advantages, but if you're the purchaser, then the advantages of that are less than obvious.
On the subject of voting in your own interest, really, who doesn't vote in their own interest? (Vince?)
> The current ETP infrastructure is well-proven
> and now provides all significant functionality
Documentation for the current ETP infrastructure is not available publically, nor is it standardised - except to the extent there is an agreement between the two current players to play nice with each other. There is no scope for entry into the market - it is exactly what the large players want - a cosy little duopoly with the pharmacy guild on one side and the RACGP on the other.
If we are all happy with that then fine - it seems to work - but let's not kid ourselves it is some sort of transparent standards nirvana out there.
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