MSIA calls for extension to PCEHR deadline due to safety risk

The Medical Software Industry Association (MSIA) has called for a 12-month extension to the roll out of the PCEHR in order to fix what it says are serious threats to patient safety.

Addressing the Senate hearing into the PCEHR bill this morning, Dr Vince McCauley, treasurer of the MSIA and CEO of McCauley Software, raised serious concerns about the functioning of some aspects of the PCEHR, in particular the national healthcare provider and individual identifiers, as well as the Australian Medicines Terminology (AMT).

Dr McCauley raised specific concerns about the national Healthcare Identifiers Service, telling the committee that the MSIA believes that in its current form, the 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 McAuley 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."

He said the MSIA has had concerns about patient safety due to the identifiers service for some time, and was particularly concerned that there were no risk safety assessments available to reassure healthcare providers that the system was safe.

"We initially believed they could be addressed, but over the last few months we realised those safety concerns cannot be addressed without an independent assessment," he said.

"In its current form the service cannot be operated safely. NEHTA's safety committee was asked to assess the situation and they also endorsed that conclusion."

He said the problem was not due to the operator of the service, Medicare, as it had implemented the specification provided by the National E-Health Transition Authority (NEHTA).

He also raised concerns about the AMT, saying medical software companies had devised their own coding systems for medicines that have been validated and work, and they were now questioning why they should change to a system that has still not been completed and was an unknown quantity.

“The AMT has serious issues around its correctness and its utility,” he said. “The AMT has been implemented in a trial in one sector and is not widely available. Moving from diverse systems to a single terminology is not going to happen before July 1, and there is no intention to audit or manage that medicines list.

“Those terminologies that will result in patient safety have not been completed or rolled out. Despite five years of work those terminologies are not ready. So to expect those terminologies to be used to populate the PCEHR is not possible.”

Jon Hughes, president of the MSIA and CEO of Smart Health Solutions, which is taking part in two of the Wave 2 trials in NSW, called for an immediate extension to the PCEHR roll out of 12 months from July, and for a much more simple record to be made available by the Federal Government's deadline of July 1.

“The PCEHR is extremely complex in the clinical documents it contains,” Mr Hughes said. “A feasible solution is to simply contain images of reports that are currently produced by health information systems (such as specialist letters etc) as PDF documents.”

He said PDF copies of documents currently produced by health providers could be viewed online and would mean a PCEHR would be available by July 1, with more work over the next year required to correctly design technology to view the more complex, atomised data for the complete PCEHR.

“That would work fine without needing to get to the detail that needs to be interpreted by computer systems,” he said. “The risks and complexities have not yet been solved. Setting aside the health identifiers, [the current pause in NEHTA's roll out] would largely be obviated by a move to a simpler document.

“Clinicians share these documents now and it would work perfectly well in a PCEHR rather than a re-presentation that relies on new technology.”

Mr Hughes said the MSIA, while strongly supportive of the PCEHR and having participated in many of the technology groups to ensure the program was a success, is highly concerned about four key issues: These include:

  • The PCEHR is characterised by risks to patient safety even before development has been completed. The MSIA recommended several months ago that the PCEHR program should be paused or significantly reduced in scope until safety and other implementation issues have been addressed.
  • With less than five months to go before the deadline of July 1, NEHTA has not provided a commercial model that will support the national eHealth program in the long term.
  • The program has ineffective project management, unrealistic deadlines, inadequate review processes for specifications and a lack of progress to Australian Standards, with consequences for patient safety.
  • The industry has lost confidence in NEHTA's ability to manage the program. A joke within the industry was that NEHTA stands for 'never ever having to achieve'.

Mr Hughes said the MSIA had four recommendations to fix what it sees as the major issues:

  • Reduce the complexity and scope of the program. A reduced scope can still be delivered by July 1 if certain components are removed, he said. He called for a new 12-month program, extending to 1 July 2013.
  • The provision of certainty for the health sector by requiring the Department of Health and Ageing to develop a sustainable business model for eHealth that pays healthcare professionals and their technology providers fair fees for helping to deliver better health outcomes through the use of eHealth technologies.
  • Regarding patient safety, the committee should immediately subpoena documents from NEHTA concerning patient safety assessments.
  • The Commonwealth should take steps to restore industry confidence in the system with a formal inquiry into what has gone wrong. The MSIA recommends that the government replace, re-structure or supplement NEHTA with an eHealth management team that has a proven record in the successful implementation of eHealth programs. The MSIA proposes that an industry led task force could provide this capability.

“[A PCEHR] is a laudable goal and a desirable end point but it is not possible before the first of July,” Mr Hughes said.

NEHTA and the Department of Health and Ageing (DoHA) will address the committee this afternoon.

Posted in Australian eHealth

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