The Pharmaceutical Journal
Vol 277 No 7408 p37
8 July 2006

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Software used for clinical decision making needs to be regulated

Unless governments start to regulate computer software used to make clinical decisions, negligence cases will end up deciding how such software should be validated, an editorial in The Medical Journal of Australia argues (2006;184:600).

Enrico Coiera and Johanna Westbrook, of the centre for health informatics, University of New South Wales, Sydney, query why the safety profile of clinical software is not tested as rigorously as that of new drugs. They say that some prescribing systems are sold without rules to check for errors or guide prescribing and that there are reports of clinical software systems increasing mortality rates.

“Urgent debate is needed to move this agenda forward,” they warn. “We can move quickly to develop appropriate models of governance for clinical software, or we can step back and let the courts decide, when legal cases of negligence occur.”

The National Institute for Health and Clinical Excellence is working with Connecting for Health to look at the feasibility of approving the clinical and cost effectiveness of computerised decision support systems.