To the Editor: The editorial by Coiera and Westbrook raises some important points.1 Appropriate models of governance (vis-à-vis regulation) surrounding clinical software are required if we are to drive innovative technology on a course that is safe and effective for patients.

The success or failure of an information system depends on the organisational context in which it is placed.2 The people, the work processes and the technology must be viewed as integrated elements of one system that aims to improve health quality and, importantly, do no harm. In essence, each element provides an additional layer of quality control and safety, and these work together to avoid adverse events.

By law, we require medical practitioners to be registered. By law, we require health facilities to be accredited and licensed. We should also, by law, acknowledge clinical software as being part of the jigsaw puzzle and require that it too be regulated.

Because of the complexity of the task, in-house development of clinical systems is unattractive to organisations, leaving vendor solutions as the alternative.3 Currently, there is no apparent active engagement between software developers, government, clinicians and funding bodies to establish a transparent and sustainable program of decision-support software development in Australia.4 Beilby et al recommended a generic standards-based “middleware” that sits outside all clinical desktop software systems and supports the exchange of information with other clinical systems and knowledge repositories.4 This would be the gold standard. Inextricably linked with this would be a regulatory framework to compel software suppliers to comply with the standard. Without this, health care organisations are vulnerable to the whim of software vendors, each with different standards, capabilities and knowledge capital.

Decision-support tools to supplement memory and record clinical information and results can help standardise clinical care and reduce human error by ensuring that uniform, evidence-based practices are adopted.5 Electronic decision-support systems are currently espoused as one of the keys to good quality and safe health care.4 The health system needs this innovative technology. However, if the health system is to avoid duplication, fragmentation and inconsistencies associated with multiple standards for electronic decision-support systems and other clinical software, then we must advocate for workable standards and legislative frameworks on which to build the technical solutions. We owe this to the health professionals using these systems, who may otherwise make a wrong turn, and we owe it to the patients at the end of the line.