NEHTA rejects PCEHR safety criticisms

The National E-Health Transition Authority (NEHTA) has rejected claims by the Medical Software Industry Association (MSIA) that there are serious design flaws in important components of the PCEHR.

In a written reply to questions put on notice during a Senate committee hearing into the PCEHR in February, NEHTA defended its governance mechanisms and rejected arguments that the electronic health record would pose a threat to patient safety.

In a written submission to the Senate committee and in live testimony, the MSIA raised concerns about the functioning of some aspects of the PCEHR, in particular the Healthcare Identifiers Service and the Australian Medicines Terminology (AMT).

MSIA treasurer Vince McCauley told the hearing that in its current form, provider and individual identifiers cannot be operated safely as individual identifiers can be changed and there was the prospect of data being mis-allocated or lost completely.

“The IHI can in fact change under a number of defined circumstances but there is no system to tell practitioners of the change,” Dr McCauley said.

“We are concerned that the number cannot be validated and if it changes, the IHI will no longer be usable and the information will disappear. The specification has been shown to be inadequate and badly designed."

In its reply, NEHTA said it disagreed that this was a design flaw.

“The MSIA submission incorrectly raises issues about the safety of the Healthcare Identifiers Service which are based on misconceptions of the system design in relation to the assignment, management and retrieval of Individual Healthcare Identifiers (IHIs),” NEHTA said.

“The submission asserts that a person’s IHI can change or new IHIs are issued under certain circumstances, in particular when their date of birth or gender record changes rendering the IHIs unusable as it would not be able to be matched with the person’s demographics and therefore irretrievable and unable to be validated.

“The submission appears to confuse the management of demographic changes within the HI system with the management of duplicates.

“Duplicate IHIs do not create risks that do not already exist today. Healthcare providers today deal with duplicate records in their systems.

“Replica IHIs are not tolerated within the HI Service. No replicas have been found in the HI Service since commencement of the service on 1 July 2010.”

The MSIA also criticised the use of the AMT, claiming there were serious issues due to changes that have occurred while it was in the NEHTA process.

Dr McCauley said there were medicines terminologies already in use such as those provided by MIMS that could be easily adapted.

NEHTA said that “any statement that the AMT is not correct is false”.

“The AMT goes through rigorous verification and validation processes before it is released,” the statement read. “The eHealth ICT Implementation Committee was briefed in May 2011 on all the safety steps undertaken by NEHTA before an AMT release and Dr McCauley was present at this meeting.

“The AMT is the nationally agreed terminology for the identification of medicines in electronic health systems … The key benefit of AMT is that it enables interoperability between systems.

“These outcomes cannot be achieved by proprietary drug databases like MIMS and those used by vendors such as HCN, which may work within a specific application but are not interoperable with other systems on a national level.”

The MSIA had also raised the issue of the AMT only having been implemented in a trial of one system, and that it was not generally available. It also said it understood the auditing firm Ernst & Young had been asked to review the AMT.

NEHTA said the AMT was first released in 2007 and is now used in commercial software and deployed in 11 hospitals in Victoria within Cerner’s Millennium software.

“These are not trial systems. Since the introduction of the systems using AMT into these sites, preliminary results show major reductions in prescription errors, so it is incorrect to say that these implementations are not meaningful.

“Contrary to the statement that AMT is not generally available, in fact the AMT is released every month, free of charge by NEHTA, so is widely available.”

NEHTA said the statement that Ernst & Young had been asked to review the AMT was wrong. “Ernst & Young has not been engaged, to NEHTA’s knowledge, to conduct any such review.”

NEHTA also defended its governance arrangements, saying it was governed by a board of directors consisting of the CEOs and director‐generals of the nine Australian state, territory and Commonwealth health departments, plus two independent directors, one of which holds the position of chair.

“The NEHTA CEO also appears before Senate Estimate hearings to provide additional transparency, although there is no requirement to do so.”

The MSIA had suggested a 12-month extension to the roll out of the PCEHR in order to fix what it saw as serious design flaws. It recommended that instead, a solution could include images of reports that are currently generated, including discharge summaries, event summaries and referrals.

NEHTA said that although the task of building the specifications is not trivial, it has proven to be within the capability of typical software vendors, both large and small.

“NEHTA is working with software vendors to implement NEHTA specifications and software vendors have worked successfully with NEHTA on integrating the specifications.

One of the strongest criticisms the MSIA made was in reference to the industry's confidence in NEHTA's ability to deliver the PCEHR. It said the industry had lost that confidence, and that there was “evidence of a lack of probity, ineffective governance and an inability to deliver targeted programs”.

NEHTA said that statement was not supported by the industry.

“Since the Senate hearing NEHTA has been contacted by numerous members of the MSIA and broader industry to distance themselves and their organisations from Dr McCauley’s testimony.

“NEHTA is committed to and actively working towards the timelines agreed with the sector which would see consumers able to register for a PCEHR on July 1.”

An MSIA spokesperson said the association had not prepared a response to NEHTA's statement but would be holding a forum on April 24 at which its response to the Senate committee's report, to be released this evening, would be discussed in full.

Posted in Australian eHealth

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