This paper describes a rigorous yet practical process for evaluating mobile health care products (native and webbased software applications) to identify design issues that present a risk to patients. The process uses a model-based approach to application analysis, combining techniques from human factors, human-computer interaction, safety engineering and patient safety. Examples from mobile products in development are used to illustrate how the process facilitates detection of common design issues. Lessons learned from developing and applying the process also are discussed.
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