NEHTA – What is the Status of All These Specifications?

In a very recent press release from NEHTA there is the following:

http://www.nehta.gov.au/index.php?option=com_content&task=view&id=182&Itemid=144

“NEHTA sets direction for electronic messaging in health

NEHTA confirms Health Level 7 as the national standard for the electronic messaging of health information across Australia.”

This set me to wonder, just where does NEHTA derive its authority to reach such conclusions? It is neither a government entity nor is it actually funded to make any product procurements which would seem to be the point at which what NEHTA wants and what the market has to offer intersect.

NEHTA's position would appear to be stated in the following terms (From the National E-Health Standards Development A Management Framework Version 1.0 – 15/03/2006):

“3.3 Compliance

NEHTA's role includes the development of specifications for inclusion in Government and potentially other health sector procurement processes. These specifications will be technical in nature, normative, and incorporated into commercial contracts.

On their own, standards or technical specifications have no legal status and are free to be followed or not by manufacturers, consumers or the public. However, if a Standard or specification is referenced in legislation, or written into a commercial contract, it becomes enforceable by virtue of that legislation or contract. When this happens, Standards become mandatory and their reasonableness, quality and impact can be subject to the scrutiny of the courts. Accordingly, standards development organisations make every attempt to ensure that the principles and processes used to develop standards are based on good practice.

In respect of “specifications” such as those produced by NEHTA, the WTO Agreement on Government Procurement states that:

“Technical specifications prescribed by procuring entities shall, where appropriate:

(a) be in terms of performance rather than design or descriptive characteristics; and

(b) be based on international standards, where such exist; otherwise, on national technical regulations, recognized national standards, or building codes.”

Further to this the Council of Australian Governments (COAG) recently committed to: “promoting compliance with nationally-agreed standards in future government procurements related to electronic health systems and in areas of healthcare receiving government funding.”

While not being a lawyer, this seems pretty clear to me. The key points are:

1. Standards and specifications only become enforceable if they are either legislated or become part of a commercial contract.

2. If they become part of legislation or a commercial contract they are testable by the courts for their “reasonableness, quality and impact”.

3. To be valid they must be developed by appropriate processes.

4. They should be performance based (i.e. lead to an outcome if adopted – e.g. a level of fire resistance of material which if used will save life or property or with e-health, for example, be demonstrably workable and able to be implemented)

5. Be based on international standards unless there are compelling gaps in what is available internationally which need to be filled.

Most important, it seems to me, is the quality and depth of the development processes.

Standards Australia summarises the process needs very succinctly.

http://www.standards.org.au/cat.asp?catid=6

“Cardinal Principles of Australian Standardisation

Open
Any affected or interested representative organisation has the opportunity to participate.

Balanced
The committee shall be balanced and not dominated by any single interest category or organisation.

Due Process
All valid objections shall have an attempt made towards achieving resolutions.

Consensus
More than a majority but not necessarily unanimity.”

Standards Australia also succinctly summarises the legal status of their work as they see it:

http://www.standards.org.au/cat.asp?catid=7

“The legal status of Australian Standards®

Standards Australia is an independent organisation and our Standards are not legal documents. However, because of their convenience and the willingness of all parties to adopt them, many of the documents are called up in Federal or State legislation, with the result that they then become mandatory. Currently about 2400 of our Standards are mandatory, however most are used voluntarily by people who value their expertise and commonsense. They are practical and don't set impossible goals. They are based on sound industrial and scientific experience. And, because they are regularly revised, they keep pace with new technologies.”

It is interesting that much of the spirit of this is captured in the NEHTA Standards Development Framework document. However, I think there are many who think NEHTA's compliance with the requirements for openness, balance, due process and consensus is yet to be seen.

Equally the comments from Standards Australia on the need for practicality and the use of experience seem highly appropriate – and these have yet to really be taken to heart by NEHTA.

It is also interesting that after operating for over two years NEHTA finally perceived that it needed a formal documented relationship with Standards Australia on February 9 this year. See

http://www.nehta.gov.au/index.php?option=com_content&task=view&id=178&Itemid=144

I also find it fascinating that as of February 2, 2007 NEHTA can say – in the description of the document entitled “Supporting National E-Health Standards Implementation v1.0” the following.

“The consistent implementation of health informatics standards is critical to achieving an information technology enabled health sector within Australia. The structure of the health system in Australia is diverse and dynamic, which does not readily support standards implementation. To achieve the e-health goals for Australia it is necessary to address the current challenges associated with standards implementation.

The purpose of this document is to provide guidance to those in the health sector responsible for improving care delivery through information technology by identifying some of the challenges to health informatics standards implementation; defining adoption, uptake and implementation; and clarifying the strategies and activities that will assist in resolving the challenges. A framework to support successful standards implementation is also described.

This document completes the development of NEHTA's National E-Health Standards Plan.”

What is being said here, as I read it is:

1. This is all very hard (or, we think we need help, but who can help us?)

2. Someone – i.e. you out there - have to address the challenges it poses (or, we can only tell you what to do but you have to do it and make it work)

3. Here is a document to tell you how – with such memorable quotes as “The onset of e-health breeds confusion due to fear, uncertainty and doubt.[5]” – Page 6. (or, is it any wonder we are confused?)

4. We have done all we can – so over to you (or, we hope we’ve helped, good luck in your future endeavours).

Surely something as basic as a Standards Plan needs to be a living, developing, learning document – not a fait accompli.

That many in the Health IT industry are only reading NEHTA's documents “when there is nothing more useful to do” seems a valid approach to be adopting until the NEHTA processes move to a more appropriate level of consensus creation, communication and consultation.

It seems to me NEHTA has to do a much better job of explaining to the Health IT community the value and usefulness of their efforts for them to have much real impact and that pretending (with the words quoted in the compliance area above) they have legal enforceability on their side is probably little more than a rather pathetic bluff.

NEHTA does not have legislated authority and their specifications and recommendations are not the product of a recognisable standards creation process as they are traditionally undertaken.

For NEHTA to ever be really relevant a lot needs to change – and soon.

David.