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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.


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


Correspondence: e.coiera@unsw.edu.au

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.

  • 1. Miller RA, Gardner RM. Recommendations for responsible monitoring and regulation of clinical software systems. American Medical Informatics Association, Computer-based Patient Record Institute, Medical Library Association, Association of Academic Health Science Libraries, American Health Information Management Association, American Nurses Association. J Am Med Inform Assoc 1997; 4: 442-457.
  • 2. Wang CJ, Marken RS, Meill RC, et al. Functional characteristics of commercial ambulatory electronic prescribing systems: a field study. J Am Med Inform Assoc 2005; 12: 346-356.
  • 3. Garg AX, Adhikari NKJ, McDonald H, et al. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA 2005; 293: 1223-1238.
  • 4. Kawamoto K, Houlihan C, Balas EA, Lobach DF. Improving clinical practice using decision support systems: a systematic review of randomised controlled trials to identify system features critical to success. BMJ 2005; 330: 765-768.
  • 5. Ash JS, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system related errors. J Am Med Inform Assoc 2004; 11: 104-112.
  • 6. Wears RL, Berg M. Computer technology and clinical work — still waiting for Godot. JAMA 2005; 293: 1261-1263.
  • 7. Koppel R, Metlay JP, Cohen A, et al. Role of computerized physician order entry systems in facilitating medication errors. JAMA 2005; 293: 1197-1203.
  • 8. Han YY, Carcillo JA, Venkataraman ST, et al. Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system. Pediatrics 2005; 116: 1506-1512.
  • 9. Coiera E. Four rules for the reinvention of healthcare. BMJ 2004; 328: 1197-1199.
  • 10. United States Food and Drug Administration. Premarket notification 510(k): regulatory requirements for medical devices. Available at: http://www.fda.gov/cdrh/manual/510kprt1.html (accessed May 2006).
  • 11. Australian Health Information Council. Electronic decision support evaluation methodology. Available at: http://www.ahic.org.au/evaluation/index.htm (accessed May 2006).
  • 12. Miller RA, Gardner RM, Johnson KB, Hripcsak G. Clinical decision support and electronic prescribing systems: a time for responsible thought and action. J Am Med Inform Assoc 2005; 12: 403-409.

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