Letters
Volume 186 - Issue 11

Should clinical software be regulated?

Author:  Enrico W Coiera

Med J Aust 2007; 186 (11): 607-608. || doi: 10.5694/j.1326-5377.2007.tb01071.x
Published online: 4 June 2007
Download PDF (231 KB)
Share: Share on Blue Sky Share on Facebook Share on LinkedIn Share by email

In reply: At the heart of much debate on patient consent for access to electronic data are two conflicting desires — many consumers wish to minimise access to their record, and many clinicians have genuine concerns that such restriction may lead to patient harm. In some cases, privacy is paramount (eg, psychiatric or sexual health history). In others, such as emergency presentations, patient wellbeing may override such concerns. This has led many to conclude that there is no “one size fits all” model for e-consent.1

The current debate between the boundary cases of “opt-in” and “opt-out” is misleading because many specialist services of necessity will have local consent processes, crafted to meet the need of their patients and their clinicians. Yet, many health information technology initiatives do not seem prepared to consider this complexity, and opt-in or opt-out are all that is on offer. Liaw and Boyle’s concerns about dropout rates under an opt-in system affecting secondary use of patient data for research purposes are no doubt real, but it is hard to draw too strong a comparison between patient recruitment for research and patient permission to store data for their own care.

Williams correctly points out in his letter that decision support remains a small component of the software to support clinical practice that most Australian general practitioners now use. However, anyone using a prescription program that suggests doses, checks interactions, or generates alerts is using decision support. We can say so confidently because research repeatedly shows that such functions change clinical decisions. Indeed, something as simple as accessing research articles and guidelines using the Internet is a form of decision support, because it changes clinical decisions significantly, and sometimes negatively.2 Consequently, it is perhaps naïve to await “true” decision support using artificial intelligence before we worry about how software affects clinical behaviour. If the intervention was a drug and serious patient harm resulted from infrequent side effects, everyone would quickly agree some controls might be needed. Somehow, we still don’t seem to get as excited about the harm that may come from using bread-and-butter clinical software, but we should.

Author

  • Enrico W Coiera1
  • 1. Centre for Health Informatics, University of New South Wales, Sydney, NSW.

Correspondence: e.coiera@unsw.edu.au

References

View this article on Wiley Online Library