Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering
|Publication Date:||1 January 2020|
This part of the HIT1000 standard describes an approach to developing and validating a health IT system's user interface so that such systems are safe and effective. The intent is to promote good development practices without being overly prescriptive.
In line with the approach of the HIT1000 series, this document describes how to apply a user-centered design process throughout the entire health IT lifecycle. As such, this provisional standard covers the development, acquisition, integration, implementation, and operational use lifecycle stages. Additionally, the provisional standard includes a section describing usability considerations for health IT system replacement and decommissioning.
Given the importance of human factors engineering during the development process and the iterative nature of health IT system design and development, the development section generally serves to outline the user-centered design process in detail, while the following sections (e.g., integration, implementation) include references to certain sub-steps within the user-centered design process (e.g., usability evaluations, risk management).