The standards setting processes are broken and no one seems to care

---

Before discussing the present issues in Australian E-Health setting a little background in two areas seems justified. We can consider these issues by responding to key questions.

---

1. Why do Standards matter?
Standards are important in all industries to ensure the quality, safety and predictability of all goods and services. We have food standards to help prevent food poisoning and building standards to help ensure buildings are safe, fit for purpose and proof to reasonable environmental impacts (earthquake, bushfire etc.). Another vital function of standards is to permit safe interchangeability and interoperability; think of things like screw threads etc.
E-Health has, as its primary concern, the safe and secure transmission of clinical information between healthcare providers and between providers and their patients. To this end standards have been developed covering such things as electronic health records, secure health communication, health data and information standards and so on.
You can see the scope of the various standards that have been developed for Australia (in association with the IT-14 Committee of Standards Australia) on this web-page: www.e-health.standards.org.au/Home/Publications.aspx
Interestingly the Australian Institute of Health and Welfare (AIHW - www.aihw.gov.au) also has a role in developing a range of data definitions, and the National E-Health Transition Authority (NEHTA) has also had a role in clinical terminologies as well as attempting to manage / interfere with (depending on your perspective) the standards development process over the last few years.
Before discussion proceeds it is also important to point out that standards adoption by commercial and government entities can minimise risk and reduce the costs of bringing new services and products to market while also assisting in broadening the capabilities that may be offered. It is quite usual for companies to find that there are distinct advantages in standards adoption and use - not the least in facilitating future-proofing development efforts. Of course, for some standards adoption is compulsory and enforced by laws (e.g. food standards).

---

“E-Health has, as  its primary concern, the safe and secure transmission of clinical information between healthcare providers  and between  providers and  their patients.”
DR DAVID MORE

---

2. What is the present process in Australia for their setting?
In ordinary times - and the last few years in e-Health can hardly be seen as ordinary - there was a stable and well thought out, consultative and inclusive process for e-Health standards development. Work began seriously on the Health Informatics domain around 20 years ago with Standards Australia creating a steering committee (to become termed IT-14) to develop and implement a work plan. Key to this plan was to leverage all available international work (especially EU and USA) and to only develop new standards if international approaches could not be reasonably adopted. The intent was to maximise the level of international engagement of the local development committees.
IT-14 has a range of sub-committees and a wide range of members. This page provides a useful collection of links: www.e-health.standards.org.au/ABOUTIT014.aspx
Once a work plan is developed for a period the chairs of the various subcommittees - facilitated by Standards Australia staff convene meetings of volunteer experts representing a full range of stakeholders to develop a draft standards document. The draft is then workshopped as needed and a balanced consensus document is developed. Only once this is fully agreed is an Australian Standard, Technical Report or Technical Standard published.
The keys to the process are seeking conscious involvement of as many interested parties and technical experts as possible and a consensual open way of working and document development.
3. What has changed and what has gone wrong?
By my reckoning the system of e-Health standards setting was working relatively well until around 2010. Most needed standards were being developed with reasonable speed and quality with the help of a large and expert volunteer workforce and reasonable support from Standards Australia. This is not to say all was ideal, but in most areas some progress was being made, especially in terms of clinical messaging while - as in the rest of the world - many aspects in interoperability were being found complex and difficult. The whole area is recognised as being very complex as was well articulated in a blog by Thomas Beale in 2009. (http://wolandscat.net/2009/09/17/the-crisis-in-e-health-standards/). Only recently have we seen some steps to try and address these issues by initiatives such as HL7’s FHIR (Fast Healthcare Interoperability Resources) initiative.
Also, the Commonwealth Department of Health was funding access to the relevant standards for no charge and providing funds to ensure Australian experts were able to attend relevant major international meetings of bodies like HL7 and the ISO-TC-215 Committee so Australia was well linked into international trends and contributing where appropriate.
In 2010 the then Government announced it was going to implement a National Personally Controlled Electronic Record (PCEHR) and that it was going to be operational 1 July, 2012. In an attempt to have all the needed standards in place well before the deadline (so they could be actually implemented) many of the usual processes were abandoned with NEHTA led ‘Tiger Teams’ developing specifications which were then to be signed off by the volunteers. Not surprisingly there was considerable dissension and friction with many of the volunteers simply walking away and being replaced by NEHTA Staff. Additionally there was quite substantial funding provided by government in this period to shape what activities were ramped up and what were deferred.
Also there were a range of quite fundamental technical directional choices where the was considerable disagreement between NEHTA staff and many of the volunteers. Many of the volunteers felt they were being ignored and so became rather disillusioned.
To make matters worse NEHTA continued to pressure the acceptance of untested and unimplemented specifications which rather went against the usual standardisation approach of incremental development, testing and proof of concept and then implementation. Only when implementation was successful would further development take place. The failure to assess the quality of the various standards proposals by way of formal evaluated implementation was, in my view pressured by artificial deadlines and a fatal flaw in what was being done by DoH and NEHTA.
In more recent times we have seen an accelerating loss of volunteers, failure to develop, agree and fund the 2014-2016 Work Program for IT-14. As of the time of writing (Oct 2014) there has been no update of the Standards Australia e-Health site since May 2014 and most funding for meeting travel has been curtailed or cancelled.
Also, as of the time of writing, the fate and plans for the PCEHR are still in limbo with no outcome after a consultation period which closed late August 2014.
It would be fair to say, I believe, that for the present the Australian e-Health setting system is essentially ‘down for the count’. Whether it will ever recover in any useful form would have to be a completely open question. Essentially a largely working and valuable system has been damaged out of recognition by government / NEHTA blundering, impatience and incompetence. Sad!
As always it seems it is the quality of leadership and governance, along with the preparedness for honesty and appropriate introspection and insight, that offers the best hope. Right now these do not seem to be in place.
History link:
books.google.com.au/books?id=DHzOJaNaOYkC&pg=PA25&lpg=PA25&dq=Standards+IT-14+History&source=bl&ots=FyGwX0AxD8&sig=8KMdCbTxGeWK_ hNdGGKrP60aoyA&hl=en&sa=X&ei=JjMqVMPnE8S78gXUlICoCg&redir_esc=y#v=onepage&q=Standards%20IT-14%20History&f=false
Dr David More
Health IT Consultant
Dr David More is a  Health IT consultant with  more than 20 years’ experience in the e-Health area. His blog can be found at aushealthit.blogspot.com and covers all matters e-Health. He may be contacted via the links provided on the blog.