Industry agreement on e-health software standards

Peter Dinham
Sunday, 06 December 2009 13:27

IT Industry - Market

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

In a joint statement released this week, the medical software and standards compliance industry heavyweights - 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) – have defined and agreed the principles on which compliance, conformance and certification of software products will be based.  The four also outlined a cost-effective pathway to standards development using existing industry mechanisms.

In their agreement, the industry bodies also addressed issues of concern for the commercial software industry, which they said helped to “clarify market confusion around roles and processes, and guiding NEHTA in the development of Australia’s premier e health conformity assessment scheme.”

The joint statement said 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.

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.”

According to Fleming, “the development and adoption of national specifications, and a supporting standards framework, is critical for improving patient care and healthcare delivery for all Australians.”

Under the agreement, 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.

Fleming said that “where appropriate, external third-party assessment will be undertaken by independent agencies accredited through internationally-recognised accreditation organizations, such as NATA and JAS-ANZ in Australia.”