This document provides the empirical rationale for critical patient safety-related usability guidelines for standardization. As well as requirements for validation testing to ensure safety-enhanced design. These standardization guidelines are targeted at eliminating 'never events' and associated patient harm by proactively addressing and mitigating the root causes of use errors from EHR design and implementation elements, as characterized in our framework on the relationship between usability and patient safety (NISTIR 7804). Requirements for validation testing are instantiated through realistic use cases that can be applied during design and evaluation of Electronic Health Record (EHR) systems and for user performance testing. The ultimate goal is to drive and empower effective and safe human performance in the use of EHRs. The objective of this research is to enhance safety-related usability with empirically derived guidance in order to improve the effectiveness and efficiency of EHRs by eliminating or reducing the most critical and likely causes of patient harm from mistakes and errors in interaction.
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