Development of safety and usability guideline for clinical information system

Clinical information systems (CISs) that do not consider usability and safety could lead to harmful events. Therefore, we aimed to develop a safety and usability guideline of CISs that is comprehensive for both users and developers. And the guideline was categorized to apply actual clinical workflow and work environment.The guideline components were extracted through a systematic review of the articles published between 2000 and 2015, and existing CIS safety and/or usability design guidelines. The guideline components were categorized according to clinical workflow and types of user interface (UI). The contents of the guideline were evaluated and validated by experts with 3 specialties: medical informatics, patient safety, and human engineering.Total 1276 guideline components were extracted through article and guideline review. Of these, 464 guideline components were categorized according to 5 divisions of the clinical workflow: "Data identification and selection," "Document entry," "Order entry," "Clinical decision support and alert," and "Management". While 521 guideline components were categorized according to 4 divisions of UI: UIs related to information process steps, "Perception," "Recognition," "Control," and "Feedback". We developed a guideline draft with 219 detailed guidance for clinical task and 70 for UI. Overall appropriateness and comprehensiveness were proven to achieve more than 90% in experts' survey. However, there were significant differences among the groups of specialties in the judgment of appropriateness (P < .001) and comprehensiveness (P = .038).We developed and verified a safety and usability guideline for CIS that qualifies the requirements of both clinical workflows and usability issues. The developed guideline can be a practical tool to enhance the usability and safety of CISs. Further validation is required by applying the guideline for designing the actual CIS.