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:
- 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.
Posted in Australian eHealth