"A clinical safety case report for release 1a is currently being prepared," Nehta says in just-provided answers to Questions on Notice during a February Senate estimates hearing.
"This report does not focus on the live clinical environment; rather it primarily focuses on potential clinical hazards introduced through the delivery of the PCEHR national infrastructure.
"Testing by the software developers is still underway at this stage.
"Ongoing identification and analysis of clinical hazards will continue until it informs the go-live decision for PCEHR release 1b and, importantly, post deployment into the live clinical environment."
Nehta says release 1a provides an environment in which local software-makers can test their products against the national infrastructure, retrieve information from the PCEHR for test purposes, and upload clinical documents to the system.
"Nehta considers that there are no unacceptable residual risks present in release 1a, with respect to the delivery of PCEHR infrastructure."
However the "safety report" does not examine key patient safety concerns that may arise from the introduction of the personally controlled e-health record system across Australia.
The Medical Software Industry Association called on a recent Senate inquiry to subpoena all patient safety documents so they could be scrutinised by independent experts.
The MSIA's concerns were rejected by Nehta.
Nehta chief executive Peter Fleming assured the inquiry the authority was "working hard to provide copies of clinical safety documents as requested at the public hearing".
"These documents will be provided to the committee as soon as possible."
To date, these have not been released.
Last October, MSIA issued a white paper warning of unresolved patient safety and liability concerns to all members of the HI stakeholders working group, and later obtained by The Australian.
In December, Health rejected The Australian's Freedom of Information request for "any document of any name performing the function of examining risks to patient safety" on the grounds that "the documents do not exist".
Now Nehta has told the committee it is using BT's Sentry clinical safety management system to help identify and analyse hazards, and manage mitigations.
"The goal of Sentry is to ensure that the residual clinical risk associated with Nehta products is as low as reasonably practicable," it said.
"In addition to providing a safety case approach, Sentry promotes an effective safety culture within Nehta."
The BT Sentry system was used in Britain's National Health Service IT project in England, and to help deliver the NHS's national spine database, Nehta said.
"A full end-to-end risk assessment of the PCEHR eco-system -- from user to system and back -- is currently being conducted," it said.
"Work is underway as part of the change and adoption process to keep healthcare consumers informed of the security measures being provided to protect their health information."
Meanwhile, changes to the design of the Healthcare Identifiers service after it was switched on in July 2010 have cost $3.8 million.
In January, it was revealed that Medicare would be given an additional $34m to upgrade the 18-month-old and still barely used HI service to support the PCEHR.
The money would also allow Medicare to "build a PCEHR-conformant repository to potentially hold Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Australian Childhood Immunisation Register and Australian Organ Donation Register data".
The HI service, which cost $90m to build and was “launched” by former health minister Nicola Roxon on July 1, 2010, has lain largely idle due to a lack of interest from health providers. To date, it has only been used in limited pilot projects at sites trialling the PCEHR program.
As HI service operator, Medicare will be given new funding to "create interfaces with the PCEHR core systems to enable registrations, and to allow the Department of Human Services (DHS) to manage enquiries", the federal Health department says in its submission to the Senate inquiry into the PCEHR Bill and related matters.
The HI service, repositories and customer call centres are all needed to support the launch of the PCEHR system on July 1 this year.
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Autor(en)/Author(s): Karen Dearne
Quelle/Source: Australian IT, 04.04.2012
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