Conclusions: There are significant gaps in the safety initiatives for HIT systems. Current initiatives are largely focussed on software. With the exception of diagnostic, prognostic, monitoring and treatment software, which are subject to medical device regulations in some countries, the safety of the most common types of HIT systems such as EHRs and CPOE without decision support is not being explicitly addressed in most nations. Appropriate mechanisms for safety assurance are required for the full range of HIT systems for health professionals and consumers including all software and hardware throughout the system lifecycle. In addition to greater standardisation and oversight to ensure safe system design and build, appropriate implementation and use of HIT is critical to ensure patient sa….