PCEHR safety and liability: who takes the rap?

The issue of potential liability for misadventure due to errors in the PCEHR is still being worked out with doctors' professional associations, less than five weeks before the system is about to launch, a Senate Estimates hearing was told last night.

A clinical lead for the National E-Health Transition Authority (NEHTA), Dr Chris Mitchell, told the Senate Community Affairs committee that medico-legal issues could potentially affect adoption rates and enthusiasm amongst general practitioners.

He said while NEHTA had undertaken work with the Australian Medical Association (AMA) to develop guidelines and peer standards for the appropriate use of the PCEHR by clinicians to minimise risk, the guidelines were still in draft form.

“They are still being widely consulted through the profession,” Dr Mitchell said. “The intent would be to finalise them for other organisations to give consideration [to] and professional organisations to give advice to their members to provide a sense of better understanding. We believe that information is best coming from people's professional organisations so we are working to support that.

“The other issue is the terms and conditions for the use of the PCEHR, which are also currently under negotiation. It is ongoing work to make sure those terms and conditions meet the needs of the operator and users, and the [healthcare] providers, of the system.”

In answer to a question about “who takes the rap” for the safety of the PCEHR, representatives of NEHTA and the Department of Health and Ageing (DoHA) indicated it was a shared responsibility.

NEHTA CEO Peter Fleming told the hearing that clinical safety assessments involved clinical input throughout the process and were signed off by NEHTA's clinical affairs group.

“The work that we do is about the safety and the efficacy of the system, is it fit for purpose ... all the way through to how it will work in production, what the process is, what are the implications for the clinician using it, so it covers all of those areas,” Mr Fleming said. “It must be fit for purpose.

“NEHTA takes responsibility for all of the steps ... We have had clinicians involved in that all the way through. We have been working with [DoHA] very closely and the Chief Medical Officer is involved, looking at what happens on an ongoing basis in the operational context.”

Mr Fleming said that consumer ownership of the PCEHR can be considered another safety mechanism.

DoHA secretary Jane Halton said the Australian Commission on Safety and Quality in Health Care, established early last year, was also involved the process.

“What I would say from a safety perspective about this kind of work, is that in some ways it provides a better opportunity to 'systematise' some parts of safety than actually occur in the current world,” Ms Halton said.

“In the current world it is a one-on-one arrangement, which relies on the application and the diligence … of the particular clinician or the clinician's local IT staff. This is a bit like the airline industry – you have a capability to systematise safety in this world that you don't in the current world.”

Dr Mitchell said that from a GP's perspective, the quality of information in the PCEHR will be fundamentally dependent on the quality of data that is held in the clinical software that clinicians are using. He said his involvement in the PCEHR design had made dramatic improvements to the data quality in his own practice.

“For example, our practice is involved in a program called the eCollaborative, which is a clinical process of improving data quality in general practice and in preparation to share that information.

“Just the simple process of actually printing out my clinical records and giving them to my patient at the end of the consultation makes a dramatic difference to the quality of my notes and my records, and I think you'll see those same changes going through a whole lot of levels of the health system as we are increasing the transparency of the information.

“We all need to be very careful about this but we also need to respect that what we have got now is not perfect and what we are trying to build is better than what we've got at the moment.”

Posted in Australian eHealth

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