Experts call for national eHealth safety enforcer

Australia needs an independent oversight body to ensure the safety of complex eHealth systems like the PCEHR to minimise risks to patients, industry experts claim.

In an editorial in today's Medical Journal of Australia, Enrico Coiera, director of the Centre for Health Informatics at the Australian Institute of Health Innovation, Michael Kidd, executive dean of the Faculty of Health Sciences at Flinders University, and Mukesh Haikerwal, professor of medicine at Flinders University and national clinical lead for the National E-Health Transition Authority (NEHTA), have called for a national body to be established independent of government and industry to investigate and act upon significant risks in the eHealth system.

The researchers write that while they have previously argued for regulation of clinical software, they are also now calling for a national clinical safety governance system for eHealth. They warn of the particular risks posed by national-scale systems like the PCEHR.

“While we know something about the risks associated with clinical desktop systems, it is not yet possible to make any definitive statement about whether the PCEHR is safe or not,” the researchers write. “There is no guarantee that harm events will be rapidly identified or remediated when it is in operation. It is not even clear what safety means for such a system.

“Even if short-term performance of the new national system turns out to be safe and effective, the international experience suggests that risks will emerge with time. Preventive action to avoid an ehealth “air crash” now is a far better option than picking up the pieces after the event.”

They argue that while eHealth can bring rapid benefits to patient care, it can also sometimes lead to patient harm or death through problems in design or operation. “Chances of harm increase with known risk factors such as poorly designed software or its implementation, including rapid deployment, and poor training and support,” they write.

“...The handful of studies of e-health safety in Australia all point to clear evidence of past harms and future risks. Yet there are few working international clinical safety governance examples to follow.”

They point out that the eHealth system is fragmented, with clinical safety risk governance beyond the remit of organisations such as NEHTA or the Therapeutic Goods Administration. The Australian Commission on Safety and Quality in Health Care does have an interest in the safety of clinical decision-support software, but has no regulatory mandate, they write.

They warn that complex systems like the PCEHR pose a particular challenge. “We cannot quantify today what will result in terms of either benefit or risk. Our capacity to predict outcomes is also hindered because these systems will be used by both clinicians and consumers

“Given the systemic nature of national e-health, harm events will not be confined to individuals and may affect large groups of patients. What would a patient safety incident look like after the launch of the PCEHR? What would happen, for example, if drug allergies were incorrectly uploaded from local clinical systems, or if medication names and doses were somehow incorrectly imported and displayed?

“Most such informational errors lead to no harm or are picked up by system 'defences', such as clinician vigilance. At some point, however, patient harm will occur.”

They write that it is not possible to detect all potential risks during system development and implementation, so oversight is needed to monitor, detect and investigate safety risks, along with the ability to take remedial action.

Posted in Australian eHealth

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