Debate opens on software certification
1 June 2010: NEHTA is calling for industry comment on a new discussion paper which explores possible options for a national medical software certification program. The discussion paper is one of two new publications which describe NEHTA’s approach to conformity assessment and software testing using a risk-based methodology designed to balance the cost and complexity of testing against the quality and safety benefits it offers to vendors, clinicians and patients.
The first document, CCA Assessment Concept of Operations, describes the foundations of NEHTA’s methodology and describes the issues, terms and recommended framework for assessment, along with initial results to December 2009. It provides the context for any future certification program, the questions and options for which are outlined in a National E-Health Certification Capability Discussion Paper, which will be open for public comment until the end of July 2010.
The Manager of NEHTA’s Conformance, Compliance and Accreditation (CCA) Unit David Manfield said certification was a valuable mechanism for increasing e-health software assurance and many countries were currently developing national programs.
“However, there are important questions that need to be answered before Australia considers implementing a scheme of its own,” he said.
Extensive consultation with industry stakeholders over the past year has helped refine NEHTA’s approach to software conformity assessment.
“It is NEHTA’s job to establish the assurance benchmarks, risk analysis and tools needed to test software against Australia’s e-health requirements and we hope industry will help us develop an effective and cost-efficient system that works for everyone,” David said.
“Different tests are being designed, according to the level of technical and clinical risks in the software, and these are likely to range from simple self-checks to a possible full independent third-party assessment.
“Once requirements are set, we are keen for testing operations to be taken up by independent, accredited testing agencies who are expert in this field. It will be up to them to establish operational procedures such as timeframe and cost.”
NEHTA and key industry representatives, including the Medical Software Industry Association, signed a Consensus Statement at the end of 2009 to demonstrate their shared understanding of “conformity assessment” and endorsement of NEHTA’s guiding principles.
Want to know more?
The new conformity assessment documents, along with the Industry Consensus Statement, can be downloaded here. Please send any comments or queries to This e-mail address is being protected from spambots. You need JavaScript enabled to view it by 31 July 2010.
If you are interested in joining NEHTA’s new conformity assessment working group. Please This e-mail address is being protected from spambots. You need JavaScript enabled to view it