As noted in the Introduction, consumer mobile heath apps take many forms, and as such, conformance statements in section 3 of this standard must allow for variation based on multiple factors, including data sensitivity, the nature of conditions addressed by the app (e.g., wellness, chronic illness), and whether/how app data connect to other data sources.
In this section, three archetypal use cases are introduced. While most consumer mobile health apps will not precisely fit any of these models, the models are meant to demonstrate a continuum of issues which may be applied to any app. Use Case A covers the least sensitive example of a health app that collects user information, while Use Case B builds off of Case A with the inclusion of an external system through which personal data is synchronized with the device. Use Case C is the most sophisticated and generates the most requirements. Its description includes examples of the risk factors that should be considered by developers and users.
Section 3 (Conformance Criteria) includes discussion of considerations as to how subsets of conformance criteria can be addressed in different manners, referencing the use cases in this section as a way to provide directional, rather than pinpoint, guidance.