E-health software testing consensus statement released

Four peak industry groups have joined with the National E-Health Transition Authority (NEHTA) to develop a standards assessment approach for medical software in Australia.

A statement released in December defines ten key principles on which compliance, conformance and certification of software products will be based and outlines a cost-effective pathway to standards development using existing industry mechanisms.

NEHTA described the consensus statement as a “landmark agreement between heavyweights in Australia’s medical software and standards compliance industry.” Signatories to the agreement include the Medical Software Industry Association (MSIA), Australian Information Industry Association (AIIA), National Association of Testing Authorities (NATA) and Joint Accreditation System of Australia & New Zealand (JAS-ANZ), in addition to NEHTA itself.

NEHTA Chief Executive Peter Fleming touted the agreement as a milestone in private-public sector collaboration and a significant step towards the development of national e-health infrastructure for Australia. “The development and adoption of national specifications, and a supporting standards framework, is critical for improving patient care and healthcare delivery for all Australians,” he said.

“When systems work better together, the efficiency and accuracy of transactions improve, which creates a positive flow-on effect for clinical safety and quality.”

Dr Geoffrey Sayer, President of the MSIA, said the consensus statement reinforces the industry’s approach to medical software development.

“The commitment by the MSIA is an extension of the medical software industry’s existing commitment to quality and safety in product development and service delivery. The consensus statement supports an effective partnership for the medical software industry to deliver innovation in the best interests of patients and clinicians,” said Dr Sayer.

The signatories to the statement have achieved consensus on the following:

1. The focus in e-health for Conformity Assessment will be on specific functional capabilities of software products.
2. International and Australian standards will be used as the basis for conformity assessment.
3. A tiered approach to conformity assessment will be undertaken when applying conformity assessment for quality, safety and risk-based measures.
• Contingent on the risk involved, conformity assessment may consist of options from self- assessment through to accredited external assessment.
• Conformity assessment will be commensurate with risk and geared to minimise resources and time.
4. Accredited conformity assessment bodies (CABs) will be responsible for accredited external testing and certification.
5. Accreditation of CABs will be carried out by internationally recognised accreditation organisations, such as NATA and JAS-ANZ.
6. It is not the intention of NEHTA to become or perform the function of a CAB.
7. Existing and future conformity assessment bodies, such as AHML, will be leveraged as the basis for e-health conformity assessment.
8. Successful completion of an appropriate CCA process will be publicly recognised.
9. Whilst the CCA Framework’s primary focus is safety and quality, it will guide and assist other processes such as procurement and healthcare practice improvement.
10. The CCA Framework will focus on the foundations for e-health underpinning innovative development. Building on the agreement, NEHTA has indicated the organisation is working on an assessment framework for each of its major e-health specifications. The documentation will provide guidance on matters such as whether self assessment or third party assessment is appropriate, test specifications and test tools, and appropriate ways in which conformance claims may be presented to the market.

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