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In recent years there has been considerable discussion around the need for certification and regulation of healthcare information technology (IT). In particular, the usability of the products being developed needs to be evaluated. This has included the application of standards designed to ensure the process of system development is user-centered and takes usability into consideration while a product is being developed. In addition to this, in healthcare, organizations in the United States and Europe have also addressed the need and requirement for product certification. However, despite these efforts there are continued reports of unusable and unsafe implementations. In this paper we discuss the need to not only include (and require) usability testing in the one-time development process of health IT products (such as EHRs), but we also argue for the need to additionally develop specific usability standards and requirements for usability testing during the implementation of vendor products (i.e. post product development) in healthcare settings. It is further argued that health IT products that may have been certified regarding their development process will still require application of usability testing in the process of implementing them in real hospital settings in order to ensure usability and safety. This is needed in order to ensure that the final result of both product development and implementation processes take into account and apply the latest usability principles and methods.
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