Should clinical software be regulated?

Enrico W Coiera and Johanna I Westbrook
Med J Aust 2006; 184 (12): . || doi: 10.5694/j.1326-5377.2006.tb00411.x
Published online: 19 June 2006

New Australian evaluation guidelines will help inform the debate

It takes something like 10 years for a new compound to go from laboratory to clinical trial, and many more before a drug’s safety and efficacy are proven. Why isn’t clinical software — which might check for drug–drug interactions and dosage errors and generate alerts and recommendations to influence prescriber behaviour — treated as rigorously?1 Today, anybody with programming skill could create a rudimentary electronic prescribing package and put it directly onto the desktop of a general practitioner without regulatory approval.

  • Enrico W Coiera1
  • Johanna I Westbrook2

  • Centre for Health Informatics, University of New South Wales, Sydney, NSW.


Competing interests:

The national guidelines for the evaluation of electronic decision support and this editorial were written by the Centre for Health Informatics, UNSW, under contract from the Australian Department of Health and Ageing.


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