Health department chief information officer Paul Madden said a project governance group was needed to flag errors, and it should be able to assess and mitigate clinical risks detected by users or software makers.
Mr Madden said some technical specifications for the $500 million personally controlled e-health record system should be "signed off as ready to build" from October 31, with the rest finalised by November 30.
These specifications are being drafted by fast-track "tiger teams" set up by the National e-Health Transition Authority in response to pressure to meet Health Minister Nicola Roxon's deadline for a July 1 start.
"At this stage, the tiger teams are confident those dates will be met, but we're not going to put out a shoddy product on the basis we're out of time," Mr Madden said. "We do have to make sure we've got quality to the right level.
"But we are looking to make these specifications available so that vendors at least have the opportunity to start reading and to understand how this whole thing fits together.
"Wrapping that up in a change control process will give software makers certainty and stability.
"We'll support the specification as if it were a standard for a two-year period." Last week, Mr Madden told a Senate estimates hearing that the technical specifications "would be guaranteed not to change" in the short term, except in the case of system errors.
He later told The Australian: "If applications are thought to have a newly discovered patient safety risk when they are being built into clinical systems, then we would flag that as an immediate change.
"We're looking at an implementation governance body that can determine the intensity of a risk and assess how quickly we need to resolve it. There have been times where we've said, we'll have to stop this (application) because there's a clinical risk, but when you do a full assessment some of those risks are not found or they're considered to be easily mitigated."
Mr Madden wants the ICT Implementation Group -- comprising the Medical Software Industry Association, the Australian Information Industry Association, the Aged Care IT Association, Nehta, Medicare and Health -- to provide feedback on the proposals.
"We've asked the vendors what's required for them to understand and accept a commitment to keep the (finalised) specifications stable for that period," Mr Madden said.
They had also been asked for their views on which group should take on clinical safety oversight when a risk was identified, "so that we can nail it quickly".
"We need the capacity to quantify the risk, assess the likelihood as well as the consequences, and then quickly determine what actions to take."
Changes to specifications and alerts aimed at software makers will be published on a secure website from October 31.
"Vendors will register so we have a means of notifying alerts and expected changes," Mr Madden said. "Alerts will go out directly; we will consult on timing for less urgent changes."
A software industry source said an oversight body "would be welcome if it were actually independent, but there has been no history of that".
"Essentially, there's no real proposal on the table, it's just handwaving at this stage, as is this whole process," he said. "The tiger teams have not eventuated.
"Participation in two or three sessions have been called for at very short notice, with some 15 items on the agenda.
"If a specification that is implementable does come out of this process, it will be the first time Nehta has ever achieved that without serious revision by industry."
Mr Madden defended the tiger team approach, saying it was not a means of bypassing the usual standards-setting process through Standards Australia's IT-014 expert committees.
"There is a propensity in the health software industry to want to take things all the way through to full standards," Mr Madden said. "Other industries do rely a lot on specifications as a way of bundling components together.
"But the fact is, industry has committed to taking (some of) the specifications through that process, and this is not an attempt to undermine that.
"We could continue polishing them up, and not give the specs to anyone for another six months, but nobody gets the benefits of making decisions about the work needed so that their software can accommodate and connect to the PCEHR system."
Nehta's internal tiger teams had been working on the documents "for months", but Mr Madden had no details of participants or expertise.
The industry source said the approach was predicated on duplicating the standards process outside the formal organisations and their processes.
He feared Standards Australia would be put in the position of "rubber-stamping" specifications as national standards.
"They are proposing to turn the Nehta tiger team outcomes into unalterable standards," he said. "Unfortunately, because the Health department is funding SA's IT-014 work program, that could happen."
The source said the industry could not rely on the promise of stability, because it could not be enforced.
Documents released this month showed the tiger and review teams had to address 149 specifications still outstanding.
But Mr Madden said most of these were not essential immediately. "Picking out the key ones in front of me now, there are about a dozen," he said.
"Development didn't just start in the past few weeks. We've actually been going for months and some have been undergoing rigorous testing in consultation with clinicians and software makers.
"We're not starting from scratch. If elements exist, say in Snomed (clinical terminology standard) or Health Level 7 (messaging standard), then we've picked those up.
"So we've got a solid base, it's not like we're defining the whole world."
The key specifications for the e-health record rollout include the shared health summary, hospital discharge summary, electronic referrals and electronic prescribing.
"These are all specs that have been used and updated through the process Nehta is using with the lead sites," Mr Madden said.
Mr Madden expected these specifications would complete the Standards Australia publication process by the middle of next year.
But the entire national e-health record infrastructure build -- outsourced under contract to an Accenture-led consortium -- has been ruled out of scope.
Asked if the consortium would deliver its version of a core infrastructure based on existing and available standards in the marketplace, Mr Madden replied: "Correct.
"There is a review process for the Accenture specifications and design involving people external to Accenture, and external to Nehta as well," he said.
"But there's no intention to turn PCEHR specifications for the portal, the call centre systems, the B2B gateways, the core services and templates, into Australian standards."
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Autor(en)/Author(s): Karen Dearne
Quelle/Source: Australian IT, 25.10.2011
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