Safety Critical Systems Case Study
National E-Health Transition Authority (NEHTA)
Software Improvements in association with Hyder Consulting Pty Ltd, was selected by the National E-Health Transition Authority (NEHTA) to provide a consultancy to support development of a Clinical Safety Assessment Program (CSAP) for Clinical Terminologies. While a comprehensive set of Quality Assurance activities were currently applied to the activities of terminology services within NEHTA, there was a recognition that there was a safety dimension that aligned closely with that in Safety Critical Software Systems.
Specifically, NEHTA’s requirements were to:
- apply the practices that were currently applied in the safety critical software industry to the area of Clinical Terminologies;
- set up a repeatable program to carry out Clinical Safety Assessments; and
- ensure access to trained resources to apply the Assessment Program process when needed.
NEHTA’s goals were to:
- identify safety related issues in Clinical Terminologies products to ensure that healthcare-related software do not introduce unforeseen or uncontrolled hazards and risks;
- reduce non-tolerable risks; and
- increase confidence of users and stakeholders in the Clinical Terminologies products.
In achieving these three goals, NEHTA’s objectives were to:
- incorporate best practices from the Health industry and other related industries;
- benefit from the knowledge and skill that exists within the Safety Critical Software Industry;
- develop a proven and repeatable Clinical Safety Assessment Program; and
- develop a resource pool from NEHTA and an on-demand panel of resources trained to carry out Safety Assessments
An initial assessment of the Australian Medicines Terminology demonstrated the robustness and appliability of CSAP as developed by Software Improvements.
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