There is a paradox in the relationship between information and communication technology (ICT) and patient safety. ICT can improve the quality, safety and effectiveness of clinical services and patient outcomes,1
although the evidence base for this is sometimes weak.2
As a consequence, the rapid deployment of ICT on a national scale is a priority for many nations faced with a diminishing clinical workforce, increasing workloads, and resource constraints.3
However, ICT use can also lead to patient harm.5
Many commentators have raised concerns that ICT has yet to deliver on its promises,6
or that the rapid adoption of ICT is a risk.7
Errors persist in clinical practice even after ICT is introduced,8
because manual processes co-exist with the automated, and the interfaces between the two are seldom perfect. Others counter that such overemphasis on ICT-related harm only delays the implementation of a crucial technology that will save lives.9
It appears that we are caught in a bind. The demands for health system reform are now so compelling that there appears no choice but to implement complex ICT on a large, often national, scale. Yet these ICT systems appear less mature than we would like and our understanding about how to implement and use them safely remains in its infancy. A such, we are faced with a pressing policy challenge on both the national and international stages.10
The Institute of Medicine (IOM) of the USA's National Academy of Sciences has now issued a report entitled “Health IT and Patient Safety: Building Safer Systems for Better Care”.10a
It identifies what is known about health ICT safety, and comments on the complex socio-technical context within which these systems are developed and operate. The report makes clear that there is currently a significant gap in our understanding of the extent and severity of ICT related harm, but that to await more evidence before dealing with the problem is no longer an option. It recommends standards for safety of health IT systems be developed for manufacturers to follow, that a new federal entity be created to specifically monitor and investigatepatient deaths, serious injuries, and unsafe conditions associated with health IT, and to make public its findings. It concludes that the Food and Drug Administration should immediately begin on a framework for regulating health ICT. There is however caution in the report that safety regulations would impede industry innovation, an argument which would literally not fly in the aviation industry. Indeed dissenting views, within the IOM report and without, feel that the time for regulation has now well and truly arrived.10b
Indeed, calls for regulation of clinical software have been with us for some time now.10c
The IOM report is a welcome request both for the resources needed to fill in the gaps in our research evidence about the safety of ICT, but also to put resources into the active detection and management of ICT related harms and near misses. Its caution toward recommending regulation may however be misplaced. Simply put, if healthcare wants the benefits of ICT then it must actively manage its risks.
While basic technical standards for interoperability are now being adopted in many nations, clear standards for user interface design, decision support system construction, or clinician training are only slowly emerging. We are now beginning to appreciate the complex sociotechnical construct that is created when ICT is placed in the hands of users in busy clinical environments.11
Implementing the same ICT in highly similar organizations can still end up having different results, because of local differences in work or communication patterns.12
Our understanding of the unintended opportunities for harm that arise when interruptions and multitasking disrupt clinicians using information systems is also in its infancy. The psychological literature on interruption is complex, and designing ICT that is ‘interruption safe’ remains a challenging goal.13
If we look to industries in which technical safety is also crucial, history tells us that the journey to creating robust, industrial strength and safe systems is a sometimes perilous one.15
The aviation industry, often held up as a paragon of safety, developed its safety culture, processes and technology after a very challenging period. Commercial aircraft did crash, lives were lost, and out of catastrophic failures, learning occurred. The learning cycle repeats with every new ‘quantum leap’ in plane design and the human–machine adaptations that must follow. Technological change always creates new pathways to harm, as evidenced by the sensor malfunctions that led to the Air France airbus catastrophe.
In comparison to aviation, healthcare appears to be more complex, heterogeneous, and harder to control. Yet over the next 10 years, around the world, we will build and deploy more ICT into the health system than in the entire previous history of our discipline. These systems will be larger in scope, more complex, and move from regional to national, and possibly supranational scale. Yet we could argue that we are at roughly the same place the aviation industry was in the 1950s. Will health ICT have to go through a similar painful period of learning from unexpected accidents?
At present ICT-related errors are slowly being identified, and their different types and causations described.15a
Analysis of incident reports from the clinical front line is of particular importance right now, and is revealing the complex nature of the human and technical problems that combine to harm patients.16
Unsurprisingly, the majority of incident reports reflect the mundane reality of working in organizations in which there are power outages, resource constraints, network disruptions, and printer failures, as well as the human factors associated with working in technologically, cognitively, and socially complex environments.16
Not all types of ICT-related patient harm are the same. Some are serious, as with patient injuries from incorrect dosage of medications or radiotherapy.17a
Other events may have a minor impact on individual patients but signal widespread organizational disruption.