Letters
Volume 186 - Issue 11

Should clinical software be regulated?

Author:  Ian D Williams

Med J Aust 2007; 186 (11): 607-608. || doi: 10.5694/j.1326-5377.2007.tb01070.x
Published online: 4 June 2007
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To the Editor: The editorial by Coiera and Westbrook1 and indeed the letter by Fox2 tended to use the term “clinical software” in a broad sense.

In Australia, doctors who use clinical applications are in fact using electronic medical records. The major functionality provided is one of information storage, with the ability to produce a range of documents that were previously handwritten. To accept that the currently available applications offer decision support is a very generous, and possibly naïve, interpretation.

The common example of decision-support tools used in Australia is the humble prescription writer. Current vendors offer a variety of prescription writers and, as Coiera and Westbrook1 assert, they check for drug–drug interactions and dosage errors and provide various alerts.

Coeira and Westbrook go on to question whether appropriate testing is being performed on the large number of applications available. At first glance this question may seem to be somewhat invalid, as most of the software packages in Australia use either the AZDex (a proprietary internal drug database used by Medical Director) or MIMS (a pharmaceutical database of products currently available in Australia by CMPMedica Australia) drug databases. These two highly regarded sources of drug information provide the developer with an easy-to-implement set of tools that effectively ensures “quality” information is provided to the doctor preparing the prescription.

The problem is that, although we have quality databases, there is little or no compliance testing to ensure that the applications that use them are developed to an equally high standard. For example, there is no mechanism to inform end-users which parts of the database have been used, and there is no testing to ensure the end-user is presented with accurate information.

While many Australian doctors have moved to computerised clinical records, their ability to use these data for improving clinical care is being curtailed by a lack of standards and coding of conditions. Computers are not efficient in dealing with the free text that is traditionally used in clinical notes, and even data such as drug prescriptions are difficult to analyse because of the lack of a standard method of drug naming or coding.

I look to a future when true clinical support tools are available. To this end, the development, coordination, and facilitation of a series of standards by the National E-Health Transition Authority should be supported.

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