OBJECTIVE: To collect and critically review patient safety initiatives for health information technology (HIT). METHOD: Publicly promulgated set of advisories, recommendations, guidelines, or standards potentially addressing safe system design, build, implementation or use were identified by searching the websites of regional and national agencies and programmes in a non-exhaustive set of exemplar countries including England, Denmark, the Netherlands, the USA, Canada and Australia. Initiatives were categorised by type and software systems covered. RESULTS: We found 27 patient safety initiatives for HIT predominantly dealing with software systems for health professionals. Three initiatives addressed consumer systems. Seven of the initiatives specifically dealt with software for diagnosis and treatment, which are regulated as medical devices in England, Denmark and Canada. Four initiatives dealt with blood bank and image management software which is regulated in the USA. Of the 16 initiatives directed at unregulated software, 11 were aimed at increasing standardisation using guidelines and standards for safe system design, build, implementation and use. Three initiatives for unregulated software were aimed at certification in the USA, Canada and Australia. Safety is addressed alongside interoperability in the Australian certification programme but it is not explicitly addressed in the US and Canadian programmes, though conformance with specific functionality, interoperability, security and privacy requirements may lead to safer systems. England appears to have the most comprehensive safety management programme for unregulated software, incorporating safety assurance at a local healthcare organisation level based on standards for risk management and user interface design, with national incident monitoring and a response function. 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 safety.
International Journal of Medical Informatics, 2013, Vol 82, Issue 5, p. 139-148