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Tuesday, September 29, 2009

NEHTA and Software Certification and Accreditation. Where is it Up To?

A few months ago there was a meeting of the Senate Budget Estimates Committee for 2009-2010. It was held on 4 June 2009.

We now have some answers to Questions on Notice.


Question: E09-142

OUTCOME 10: Health System Capacity and Quality


Hansard Page: CA 70

Senator Boyce asked:

Provide an indication of what work NEHTA is due to complete and to implement this (calendar) year.


The work that National E-health Transition Authority (NEHTA) is expected to complete and implement for the remainder of this calendar year includes the following:

For the Month of July, 2009


Conformance, compliance and accreditation

(Ensuring that software complies with Australian Standards and NEHTA specifications)


A document describing how a national certification authority for e-Health related software will function will be completed during July.

----- Extract Ends.

From NEHTA we have what this is about.

E-Health Compliance and Conformance

To achieve the promised benefits that e-health offers, it is important for healthcare providers and medical software vendors to comply with e-health specifications and standards.

Compliance with these standards has two requirements:

  • conformance in the way medical software systems implement the relevant e-health specifications and standards
  • compliance by organisations that operate an e-health system or supply an e-health service with the relevant laws, codes of conduct, industry standards and principles of good governance.

Conformance, which relates to how products and services implement e-health specifications, is generally conducted through self-assessment by the party implementing the software system or by an independent third party such as a test laboratory. Conformance may also be assessed by a second party, such as a healthcare provider that is evaluating a software system prior to purchase.

Compliance, which ensures consistency among e-health specifications, usually takes the form of self-assessment, but may also be performed by an independent inspection body.

Assessment scheme

NEHTA is creating an Assessment Scheme for each of its major e-health specifications. The documentation will describe the process for assessing compliance and conformance for NEHTA’s e-health specifications and the assistance that NEHTA provides to organisations performing the assessment.

The Assessment Scheme documentation will give the following information:

  • who may perform assessment (e.g. the scope of self assessment and the role of independent test laboratories and inspection bodies)
  • guidance concerning assessment methods, test specifications and test tools
  • levels of conformance and the timeframes for achieving conformance
  • guidance concerning conformance claims by implementers and the presentation of assessment results.

For most e-health specifications, NEHTA will also provide conformance test specifications and a comprehensive list of test cases to be used in conformance testing. NEHTA may also provide test software and assistance in understanding e-health specifications.

Assistance for procurers

NEHTA provides assistance to healthcare providers procuring an e-health system with regard to tender specifications and evaluation. In particular, NEHTA can help in correctly stating compliance and conformance requirements in tender specifications. NEHTA also makes available to procurers its conformance test specifications and test tools to assist in evaluating candidate e-health systems.

This information is found here:


Needless to say this work is yet to be made public and I suspect it has not been done. It is now some months later than July. So yet again we have underperformance and in this case not properly informing Parliament of their progress.

NEHTA has been prattling on all this stuff since as far back as 2006. Indeed here we have a proposed time-line from March 2006:



  • Organisational, Informational, Technical

What do you certify?

  • Organisation
  • Implementation


  • Self-certification
  • National certification organisation
  • Certify the certifier

Leverage existing assets

Way Forward

  • Analysis of national and international approaches
  • Available options
  • Cost/benefit analysis
  • Recommended approach

By June 2006

---- End Slide

It really is about time we had some delivery in this area. For everyone’s sake we need to get some clarity about just what NEHTA is planning, where it will lead and how it is going to work.

It also needs to be presented in Draft for Discussion with industry etc so practicality and common sense prevail.

Note I much prefer the CCHIT and HITSB approach from the US to any of the ideas I see from NEHTA.

See www.cchit.org.


As I was finalising this blog MO alerted me to a related certification issue that needs to be sorted out as well. Here it is from the horse’s mouth.

Pre Publication Comment from Medical-Objects:

While a forward looking certification plan is good we are now 3 years down the track and nothing has happened.

There has recently been agreement by HCN, Healthlink and Medical-Objects that the only sensible way forward is enforced accreditation of all producers and consumers of the common HL7 V2 messages.

This was said by the CEO of Australia's most common GP package on the GPCG list:

"The only way we'll all move out of the dark ages of non-compliant messages is mandatory compliance and accreditation. Supporting old formats, non-standard formats, partially compliant formats, and lots of versions of each is a nightmare for us all. So yes to accreditation - bring it on with one key stipulation. It must be across the entire health sector not just primary care - else the result will be an even bigger mess. "

This view is widely supported and we have AHML accreditation available which would achieve 60% of this aim without setting up and specific governement organisation.

Its time it just happened. In my view this would be the single biggest advance in Health IT in the last decade.

Andrew McIntyre



Anonymous said...

One word to describe it all is - TRAGIC.

NEHTA is creating an Assessment Scheme ………..

The Assessment Scheme documentation will give …………..

NEHTA will also provide conformance test specifications ……………

NEHTA may also provide test software and assistance ……………

NEHTA provides assistance to healthcare providers procuring an e-health system with regard to tender specifications and evaluation

NEHTA can help in correctly stating compliance and conformance requirements in tender specifications

NEHTA also makes available to procurers its conformance test specifications

Nothing delivered yet ever since 2006 as you say NEHTA has been prattling away about this stuff. The language NEHTA uses here says it all . …………. will, may, provides, can …………..

No where can I see the word DOES and HAS.

You sum it up so well when you write “Needless to say this work is yet to be made public and I suspect it has not been done”.

This organisation called NEHTA is NOT ACCOUNTABLE. There are no names, no people, no faces who have publicly said “I am Harry Blogs and I am accountable for delivering this by ……………… and it shall be done”. Instead it seems we have hundreds of nameless unaccountable people beavering away for what purpose?

Anonymous said...

What happens when you are caught misleading Budget Estimates?

Anonymous said...

Good question. Ask Jane Halton.

Jim Cocks said...

Hear hear Andrew. Agreed.
This is why the Argus/MO announcement was important - it is the fundamental building block for ehealth. I think the primary healh care software providers (who have a market share to protect)have got it right despite their commercial interests - it's the Government providers who have allowed this issue to wallow in a sea of indifference for so long because their systems are either out-of-date or are in other ways non-compliant.

Other sectors like Pharmacy and Pathology providers are seemingly headed on a convergent course.

I'm increasingly coming around to the view that this is only going to occur from the "bottom up" when commercial providers will enforce the standards by sheer market pressure.

In response to the other correspondent's comments regarding Senate Estimates Committees, having appeared before one or two in my time, what happens when you (succesfully) mislead them is - you are congratulated by your Departmental Head and/or Minister!