Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records [draft] – National Institute of Standards and Technology [US] – October 2011

Posted on November 3, 2011. Filed under: Health Informatics, Medical Records | Tags: , |

Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records [draft] – National Institute of Standards and Technology [US] – October 2011

“Executive Summary

This document summarizes the rationale for an Electronic Health Record (EHR) Usability Protocol (EUP) that encompasses procedures for (1) expert evaluation of an EHR user interface from a clinical perspective and a human factors best practices perspective, and (2) validation studies of EHR user interfaces with representative user groups on realistic EHR tasks.

This document begins with a brief overview of the problem at hand: Why is EHR usability critical? There is a sentiment among clinical users that EHRs are harder to use than they need to be and can introduce “use error” that could have potential negative implications on patient care. This document centers on improving user performance of EHRs through system developer demonstration of application of human factors best practices and user-centered design principles.

Within this document there is a detailed description of research findings relating to the usability issues and their potential impact on patient care. These findings resulted in the development of a model for understanding usability and patient safety outcomes. As a backdrop, these findings motivate and guide the clinical aspects of the expert evaluation procedure.

Another intent of the EUP is to provide detailed systematic steps for conducting validation studies (that is, summative usability tests). The validation study procedure guides the reader to help insure that the application’s user interface is free from critical usability issues and supports error-free user interaction with the EHR. The sample forms for data collection and test scenarios provided in the appendices are guidance only; the development teams can choose other scenarios or modify these examples as necessary for their medical context.

This document presents a three-step process — that incorporates both the evaluation and validation procedures — for design evaluation and human user performance testing for an EHR, see Figure 1. This process is focused on increasing safe use of the EHR and increasing ease of use of the EHR by users. The steps are as follows:

1. Usability/Human Factors Analysis of the application during EHR user interface development,
2. Expert Review/Analysis of the EHR user interface after it is designed/developed, and
3. Testing of the EHR user interface with users.”

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