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Clinical Safety Assessment Program (CSAP) developed for NEHTA

The Clinical Safety Assessment Program (CSAP) is an initiative of the National E-Health Transition Authority (NEHTA) to help ensure the discovery and effective control of safety related risks, hazards and issues surrounding the creation and use of clinical terminologies.  Initially CSAP is to be applied to those clinical terminologies and related software created by NEHTA itself.

The CSAP developed by Software Improvements, supported by Hyder Consulting, essentially comprises two key, generic processes drawn from standards used in the safety critical systems industry and standard practices employed as part of the independent verification and validation of safety critical software/systems.

Overall, the CSAP aligns with two newly released (draft) health informatics standards – ISO/TS 29321 and ISO/TR 29322, which are largely based on the key safety critical systems standard (AS/ISO/IEC 61508) and to a lesser extent DEFSTAN 0056.

The generic CSAP processes are configurable for enabling the assessment of differing clinical system products or practices according to ascertained safety levels.   The configured processes consist of a set of steps to assess whether a clinical terminology product and/or the associated processes used to construct the product are appropriate for the ascertained safety level.  That is, to determine whether a product possesses the requisite quality and behaviour deemed necessary to consider it safe, and whether management and implementation processes support practices that help ensure delivery of a safe product.

The two key CSAP processes are based on: a), a hazard identification and analysis technique referred to as Hazard and Operations Studies (HAZOPS), and b), independent verification and validation processes.  Other essential CSAP processes include assessment planning and management, estimation, recommendations and reporting.

Software Improvements has extensive experience in the application of, and training in, these processes and standards.

CSAP Case Study

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