PCEHR legislation likely to pass: report

Written by Kate McDonald on .

Opposition MPs are likely to vote for the PCEHR legislation in the lower house, The Australian newspaper is reporting.

The Australian quoted Andrew Southcott, shadow parliamentary secretary for primary healthcare, as saying his party's MPs will probably vote for the passage of the legislation, but may recommended changes after the report by the Senate Community Affairs committee is released.

The committee is currently examining the legislation that will enable the PCEHR and is due to make its report to the government on February 29.

While the report and its recommendations are not binding on the government, the committee heard from a number of witnesses at a hearing in Canberra recently that there were serious concerns about a number of aspects of the bill and its amendments.

These included the governance arrangements for the PCEHR, privacy and consumer access, software glitches and functionality issues, and in particular concerns over the short time frame allowed before the PCEHR is meant to be up and running.

The Australian Privacy Foundation (APF) made perhaps the strongest criticisms on governance, calling for the legislation to be completely rewritten to ensure an orthodox governance arrangement was put in place.

The chair of the APF, Roger Clarke, told the committee the foundation did not believe the PCEHR should commence operations with the current governance arrangements intact.

“Therefore, we believe you should recommend a completely different set of governance, an orthodox governance arrangement, which does not just have an advisory arrangement with consumers and possibly—although we do not think there are any—privacy arrangements,” Dr Clarke said.

“There is at least some consumer representation in the advisory panel, but advisory is not sufficient. It has got to be a board which includes representation which has responsibilities. So I believe you have to rewrite it. That is the only way I believe that governance can be fixed.”

The Consumers eHealth Alliance also raised these concerns. Eric Browne, a member of the alliance's steering committee who appeared at the hearing, told Pulse+IT that the main issue from his group's perspective was governance.

“We need a better governance arrangement whereby the parties that have an interest in the PCEHR – the consumers, the healthcare providers, the software developers and vendors and the policy makers – all need to come together rather than being just a top-down, [Department of Health and Ageing (DoHA)/National E-Health Transition Authority (NEHTA)]-driven system,” Dr Browne said.

“The claims are made and are part of the NEHTA and DoHA submissions that consultation has been widespread, and they cite a number of meetings and roundtables, but the agendas are always controlled by NEHTA or DoHA. NEHTA sees it as a vehicle for getting answers to specific questions rather than a two-way consultation and engagement process.”

In addition to his role with the Consumers eHealth Alliance, Dr Browne is also a health IT specialist of many years' standing and a well-informed commentator on the topic of eHealth. In a post on his blog in January, Dr Browne found some serious problems with the underlying architecture of the PCEHR, especially concerning the Clinical Document Architecture (CDA) specifications.

“Having studied both the HL7 specifications in detail as well as dozens, if not hundreds of examples of CDA documents from around the world over the past 5 years, I have come to the conclusion that there are significant safety and quality risks associated with relying on the structured clinical data in many of these electronic documents,” he wrote.

“So concerned am I by this issue that I am notifying key stakeholders and urging all individuals and organisations who take safety and quality of clinical data seriously, to investigate this issue thoroughly before committing to any further involvement with the PCEHR system being rushed through by the federal Department of Health and Ageing.”

Dr Browne said that while it was test data that he used, it stood as an example of what could possibly go wrong with one of the core components of the PCEHR.

“There are two separate aspects of the living CDA document,” he said. “There are the ones that are easy to see and ones that have all the coded data, which at the moment is very difficult to see.

“One of the reasons it is very difficult to see is it is dependent on a whole lot of terminologies that clinical systems don't currently have access to and they won't have access to on the first of July.

“Even if one test site has access to it, the majority of systems that might have to read these CDA documents or even supply them won't have access to the range of terminologies and therefore it is going to be very difficult to know whether there are any risks.

“It is a potential issue and it is going to depend on how the whole thing is implemented and rolled out, and that will depend very much on what sort of compliance, conformance and accreditation (CCA) processes are going to be put in place.

“I think it would be very hard, given the architecture of the CDA and what I know about the implementation guides that NEHTA has introduced, I think it is going to be very hard to introduce a compliance, conformance and accreditation framework to validate these things in the time frame that has been laid out.”

The deep concerns of the Medical Software Industry Association (MSIA) are also on record, particularly regarding what it says are serious threats to patient safety.

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 12-month extension to the PCEHR roll out and for a much more simple record to be made available by the deadline of July 1.

The government has long said that the July 1 deadline was when consumers will be able to register for their PCEHR, not that all of the components will be ready by then.

“If all they can do is sign up to an empty folder then it is a waste of $470 million,” Dr Browne said. “If it is going to cost more to provide all of the data further down the track and to set up these CCA regimes, then who is going to pay for it?

“We don't know who is going to pay for it, we don't know what obligations are going to be passed on to the states or the software vendors – I think the software vendors have been put in a very difficult position with regards to all this because they have got to sign up to contracts when may be they don't have all of the information at the moment. That is very problematic.

“That is why we want to get the governance right. Until we get the governance right then these issues are just not going to be resolved. Not everyone is hearing all the sides of the arguments at the same time.”

The MSIA and Dr Browne raised concerns about the Australian Medicines Terminology (AMT), which both the MSIA's Vince McCauley and Dr Browne have been involved with for many years.

Dr McCauley, who was part of the group that did the initial work on the AMT for NEHTA, said it still had serious issues due to changes made concerning its correctness and its utility.

“We already have medicines terminologies in use in the system,” Dr McCauley said. “They are provided by companies like MIMS, HCN and others. They have said, 'Why would we change from using a medicines terminology that we understand and has proven safety and quality for another that is of unknown quality, unknown safety and introduces a whole range of new issues'.

“The Australian Medicines Terminology, which is a NEHTA work item, has been implemented in a trial in one system. It is not used across the sector. It is not generally available. The transition from the current usage of diverse terminology to a single terminology is a very substantial piece of work that is not going to occur before 1 July.”

Dr Browne said he was aware of some exercises where the medicines terminologies in some of the existing GP software have tried to be mapped to the AMT, and believes that also has safety implications.

“In the time frame it is doubtful that is going to happen so if the vendors are going to make an investment in changing their systems then they have to have some certainty into the future about when these promised or foreshadows improvements of AMT are going to occur,” he said.

As to whether the committee should recommend the legislation be rewritten or delayed, Dr Browne said the Consumers eHealth Alliance view was to get the governance right first and then make a decision, whether it is delaying it or reviewing it.

“Otherwise we risk repeating the same unsatisfactory outcomes that have been common overseas,” he said.

“I think it is very problematic for [the committee members] to digest all of the material, which is very complex and and which is conflicting at times.

“It is going to be very hard to make a reasonable working recommendation. I'm not an expert in Senate committees but it is going to be very difficult in such a short time frame – it is time frame pressure that causes compromise in the quality and standard of what we are trying to do.”

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