Industry heavyweights unite on Australian e-health software standards
4 December 2009. Consensus reached on a new direction for product compliance and conformance assessment. Four peak industry groups have joined with NEHTA to develop a standards assessment approach for medical software in Australia. A joint statement released this week defines the principles on which compliance, conformance and certification of software producrs will be based and outlines a cost-effective pathway to standards development using existing industry mechanisms.
The consensus statement represents a landmark agreement between heavyweights in Australia’s medical software and standards compliance industry including 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).
It also addresses issues of concern for the commercial software industry, helping to clarify market confusion around roles and processes, and guiding NEHTA in the development of Australia’s premier e‑health conformity assessment scheme.
Conformity assessment will be based on existing national and international standards and will focus on the specific software functionality components that align with NEHTA requirements.
A tiered system, ranging from self-assessment through to accredited external assessment, will be introduced to minimise the time and cost of compliance in line with product risk.
Where appropriate, external third-party assessment will be undertaken by independent agencies accredited through internationally-recognised accreditation organisations, such as NATA and JAS-ANZ in Australia.
NEHTA Chief Executive Peter Fleming applauded the agreement as a milestone in private-public sector collaboration and a significant step in the development of a 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.”
Read the Consenus Statement here.
Partner quotes
NATA is delighted to take part in this significant agreement. It recognises the key role of NATA-accredited laboratories in the assurance of technical standards in the important area of e-health.
Alan Patterson Chief Executive National Association of Testing Authorities
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.
Dr Geoffrey Sayer President Medical Software Industry Association
This is an important step towards realising the genuine benefits that the ICT industry can offer healthcare reform in Australia. Based on these foundations, the intelligent application of technology will lead to vast improvements in efficiency and high-quality outcomes for healthcare professionals and patients across the board.
Ian Birks Chief Executive Office Australian Information Industry Association
Reaching a consensus statement is the starting point for delivering innovative products under the necessary level of assurance into a complex and important market with confidence.
Dr James Galloway Chief Executive Joint Accreditation System of Australia and New Zealand