3.2.3 Usability & Accessibility

Health App Risk Management

Overview

This category is about the assessment of usability during the product development cycle, for the intended use by a target audience. Certain accessibility requirements (usability for users with specific disabilities) are recommended, but the list is not exhaustive. Other disabilities not mentioned (e.g., cognitive/learning disabilities) should be considered under the umbrella of conformance criterion #1.

Related Regulations and Standards

See Appendix: Reference Documents

Implementation Guidance

The timing of implementation of usability findings can be indicated in functional profiles based on the severity of findings. At a minimum a usability assessment plan includes information about the timeframe under which remediation will occur.

These conformance statements apply to any type of app addressed in this standard. However, specific usability measures and remediation plans will differ based on app functionality, intended users, and app platform, and as such this standard does not discuss specific controls; instead, it speaks to a development process which encourages inclusion and end user satisfaction.