How Safe is e-Health?
Software used by doctors should be as rigorously tested as new medicines, a health informatics expert has warned.
Clinical software is a rapidly expanding area in the medical industry, but Professor Enrico Coiera, Director of the Centre for Health Informatics at the University of New South Wales, said it is also the catalyst for hot debate on the benefits and downsides of new technology.
In an editorial in the latest issue of the Medical Journal of Australia, Prof Coiera called for stricter software standards.
"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," he explained.
"Why isn't clinical software treated as rigorously?"
Most evidence shows there is a benefit associated with the use of clinical software, but case reports demonstrate that sometimes information technology can cause harm.
Assigning the blame for clinical errors solely to the software does not take into account how the introduction of new technologies alters work patterns and increases the complexity of some tasks, Prof Coiera said.
It is not only the software itself that should be closely scrutinised, he added.
"Even if there were strict regulations for clinical software, there is no guarantee that software would be implemented or used safely," Prof Coiera suggested.
"The most appropriate model of governance over the safety and quality of clinical software may involve elements of industry self-regulation, legislation and best practice guidance."
In Australia, the National e-Health Transition Authority is developing basic technical standards for clinical software, and the Australian Health Information Council recently published national evaluation guidelines.
Prof Coiera says the new guidelines should be a foundation for urgently-needed debate on the matter.
"Some will argue that regulation inhibits innovation, but we can do much better by anticipating the potential risks of these technologies rather than reacting to mishap," he said.
The Medical Journal of Australia is a publication of the Australian Medical Association.