Major Standards Harmonisation Announcement and Other Things.

There have been three interesting developments in the e-Health standards world recently.

First, a week or so ago this press release was issued by the ‘heavies’ of Health Informatics Standardisation globally.

Joint Initiative of SDO Global Health Informatics Standardization

Press Release

CEN TC, ISO TC and HL7 Launch first Joint Working Group and Integrated Work Program Activities

August 28, 2007

Brisbane

CEN/TC 251, ISO/TC 215 and HL7 launched their inaugural Joint Initiative Council and Joint Working Group at a meeting in Brisbane, hosted by ISO/TC 215. This was the culmination of months of planning by the standards development organization (SDO) leaders responding to the strong call for coordination and collaboration of health informatics standards developments from government, health provider and vendor communities across the world.

The Joint Initiative Charter provides the basis, purpose, and structure of the Joint Initiative on SDO Global Health Informatics Standardization. It has been ratified by all three SDOs and was confirmed by their respective Chairs. The Charter is available from each of the SDO Secretariats.

The Joint Initiative Council and the first Joint Working Group meeting confirmed their work will build on existing agreements and recognize existing standards collaboration work already in place. The readiness to engage with other SDOs and organizations that are involved in standardization work across the globe and that have potential common work products was also confirmed.

This first Joint Working Group meeting addressed their scope, structure and related processes and introduced the first set of work items that form part of the integrated work program. That set includes an EHR communications architecture standard, a joint data types standard, care information model standards requirements and patient and medication safety standards.

To satisfy health business requirements and to identify additional integrated work items the full lists of ISO, CEN and HL7 work programs was shared at the meeting.

Along with strong support for ongoing sharing of all work programs the Joint Working Group initiated a process to identify gaps and overlaps and to rectify them.

It was noted with appreciation by all attending that there were many groups represented at the Joint Working Group meeting and the work such as the ICH pharmacy standards within ISO/TC 215 is a great example of collaboration and cooperation. Ed Hammond, newly elected Chair of the Joint Initiative Council stated “the contribution of the many experts from each of the SDOs, all working together, is a huge strength of the Joint Working Group and we fully support this collaborative

work that is so essential in delivering shared care through interoperability of our health information systems.”

The next meeting of the Joint Working Group is scheduled to coincide with the CEN

TC 251 meetings at Dublin on October 2nd, 2007.

Kees Molenaar

Chair, CEN/TC 251

Dr. Yun Sik Kwak

Chair, ISO/TC 215

Ed Hammond

Incoming Chair, HL7

ISO/TC 215 is the International Standards Organization Technical Committee for

Health Informatics http://www.tinyurl.com/2m8qxk

CEN/TC251 is the European Committee for Standardization Technical Committee for

Health Informatics http://www.tinyurl.com/2vr954

HL7 is the Health Level 7 Inc, an American National Standards Institute affiliated

Standards Development Organization http://www.hl7.org/

ICH is the International Council on Harmonization

http://www.ich.org/cache/compo/276-254-1.html

----- End Release

This looks to be an important step towards moving the international Health Informatics Standardisation process forward. It would seem to me that as the Joint Working Group starts to push forward on the areas it plans to address the scope for national standards making is going to inevitably become confined to localisation of global standards rather than de-novo standards development – recognising that each of these parties will be receiving national input as to areas that need to be addressed and suggestions as to appropriate Standards content from all those with an interest.

It is clear Australia must ensure it has a lot of solid representation in all the various working groups that will inevitably spin off from these processes.

Second, on a parallel and quite related matter I recently was alerted to a report – written by Richard Dixon-Hughes of DH4 Pty. Ltd. - on the CEN/TC 251 Working Group Meetings held in London - 11 to 12 June 2007.

As of the time of writing this report is available here.

While browsing this long and fascinating report I came upon the following section.

“7.3 NSAI (Eire) letter re standards implementation

NSAI (National Standards Association of Ireland) had written to CEN/TC 251 requesting that its standardization processes include explicit testing and evidence of implementation prior to a standard being adopted.

The WG I convener, Prof Stephen Kay, recounted the history and background to this subject and (as a member of the relevant NHS Assurance Board) noted that the NHS in the UK require implementation of a standard as part of their assurance process.

It was also noted that, within the broader standardization community, experts have not typically been successful in requiring practical implementation as part of the standardization process, although the ISO key objectives for 2005-10 includes an emphasis on implementation. Points raised in discussion included:

· Due to many factors including greater demands on time and resources, those who apply standards are often remote from the processes and experts who create them – and many users do not appreciate that they need to be involved in a standard until it has been produced

· Implementation guides and other forms of lower-consensus documentation may have a role in that they can be used as a bridge from standards makers to users – however, implementers must be prepared to use them, if they are to have value – often they prefer to hold off until a standard is fully normative.

· National or regional standardization bodies don't have a (strong) relationship with national or regional authorities which enforce the use of standards. This has to be established or reactivated.

· It may be useful to explore projects in which it is possible to handle implementation trials. In this way standards will be tested while establishing and not after when they are formally approved. Opportunities to leverage additional resources for trials need to be identified and exploited.

It was agreed that Prof Kay will draft a position paper for discussion for the next WG meetings which will address all these points.”

It is good to see the Irish stirring a little and can I say I would be much happier with all the present efforts in e-Health Standardisation if there were a set of practical but strict requirements for full demonstrable implementation of any standard that is to be balloted – let alone adopted. If interoperation is involved I would be keen to see fully developed implementation guides made available with the draft standard and at least 2-3 groups produce interoperable implementations before acceptance is contemplated.

Note: for anyone interested in the e-health standards area there is a lot of interesting reading in the full report. Thanks Richard.

Last – to bring it all together it is worth highlighting again this announcement from earlier in the week.

http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20070831/FREE/308310001/1029/FREE

Pact would coordinate key IT panels' activities

By: Joseph Conn / HITS staff writer

Story posted: August 31, 2007 - 5:59 am EDT

The leaders of two federally supported organizations—one tasked with anointing health information technology communications standards and the other with testing and certifying clinical IT systems—have proposed a formal agreement on how to coordinate their activities.

The proposed five-point memorandum of understanding would guide the relationship between the Certification Commission for Healthcare Information Technology and the Healthcare Information Technology Standards Panel. The proposal was worked out between the physician chairmen of the two organizations, Mark Leavitt of CCHIT and John Halamka of the HITSP. It is subject to review and possible amendment by the controlling bodies of the two organizations as well as their approval before it becomes effective, those leaders said. The proposal will be presented to the controlling bodies this month, they said.

The Certification Commission for Healthcare Information Technology was formed in 2004 by the American Health Information Management Association, Healthcare Information and Management Systems Society and the National Alliance for Health Information Technology as a private-sector organization to promote the adoption, particularly by office-based physicians of electronic health-record systems and other IT. In 2005, HHS awarded CCHIT a three-year contract totaling $7.5 million to develop a process to certify health IT products.

....( see the URL above for full article)

While I still see this co-ordination as very good news this paragraph – later in the article must cause some concern.

“As a result of the timing differences, at least one conflict resulted last year over data standards for the transmission of test results between laboratories and providers' EHR systems. CCHIT accepted for its criteria an older version of the Health Level Seven standard for lab results, a standard that its CCHIT members felt was, while a stretch, still reasonably attainable by the labs and EHR vendors. The HITSP, meanwhile, opted for a newer version, which would be far more of stretch, but would achieve goals set out in the AHIC use case. The HITSP's insistence on the as-yet largely unused and futuristic standard elicited protests from some providers and the national reference lab community.”

Again the flavour of standards making – if these organisations can be called Standards Development Organisations – without the discipline of implementation.

I am told informally that there is concern about the development processes used by these entities to ensure quality and robustness.

In summary of the above:

It seems to me there is getting to be too much haste and not enough speed and people are forgetting the need to make Standards both robust, agreed and implementable.

NEHTA has certainly produced a lot of documentation which has not suffered the test of implementation or practicality. This really should change.

I agree with the sentiments expressed in the second reference and reminds me of the comment a colleague used to use to describe similar situations. He used to say - "no time to do it properly - plenty of time to do it again". We need to avoid that outcome if at all possible.

David.