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Functional safety of health information technology.In an effort to improve patient safety and reduce adverse events, there has been a rapid growth in the utilisation of health information technology (HIT). However, little work has examined the safety of the HIT systems themselves, the methods used in their development or the potential errors they may introduce into existing systems. This article introduces the conventional safety-related systems development standard IEC 61508 to the medical domain. It is proposed that the techniques used in conventional safety-related systems development should be utilised by regulation bodies, healthcare organisations and HIT developers to provide an assurance of safety for HIT systems. In adopting the IEC 61508 methodology for HIT development and integration, inherent problems in the new systems can be identified and corrected during their development. Also, IEC 61508 should be used to develop a healthcare-specific standard to allow stakeholders to provide an assurance of a system's safety.