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 joint statement released this week defines the 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.

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.”

A copy of the CCA Consensus Statement can be found via http://www.nehta.gov.au/connecting-australia/cca