Consumer Mobile Health Application Functional Framework, Release 2
2.0.1 - CI build International flag

Consumer Mobile Health Application Functional Framework, Release 2, published by HL7 International / Mobile Health. This guide is not an authorized publication; it is the continuous build for version 2.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/cmhaff-ig/ and changes regularly. See the Directory of published versions

Requirements: PDS.3 Usability and Accessibility Assessment (Header)

Page standards status: Informative
Statement N:
Criteria N:
PDS.3#01 SHALL

The App SHALL be assessed against an industry-validated usability assessment tool, using subjects who are demographically-similar to intended users (target audience). For example, user types may include those with motor disabilities, visual impairment, auditory disabilities, etc. [1]
PDS.3#02 SHALL

[Intended users include those with motor disabilities] Assess product for usability by people with motor disabilities.[1]
PDS.3#03 SHALL

[Intended users include those with visual disabilities] Assess product for usability by visually-impaired and/or color-blind people using a standard mobile screen reader.
PDS.3#04 SHALL

[Intended users include those with auditory disabilities] Assess product for usability by people with auditory disabilities.
PDS.3#05 SHOULD

Assess product for usability by a sample of intended users. If geared towards a certain age segment or to people with a specific chronic health condition, or to persons with disabilities other than those specified above, usability testing subjects are drawn from these populations.
PDS.3#06 SHOULD

Create a written usability assessment plan, including known problems with product usability and mitigation plan. NOTE: for U.S. Realm when an app is sponsored by a HIPAA entity, the force of this criteria is elevated to “SHALL” with plan specifically addressing usability issues for people with visual and motor disabilities.
PDS.3#07 SHOULD

Follow design/style guide standards established by the platform provider(s) for the app (e.g., Android, iOS).
PDS.3#08 SHOULD

Avoid excessive data use by the app, minimizing it as much as possible warning users when high data usage occurs (e.g., downloads and updates).[2]
PDS.3#09 SHOULD

Describe the use cases (business scenarios) and intended users for the app’s main functions.[3]
PDS.3#10 SHOULD

Permit flexibility (adaptation) to the user’s specific abilities, needs, or requirements.
PDS.3#11 SHOULD

Provide information about accessibility characteristics in the app description and in contextual assistance sections of the app.

Notes:

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.

See Appendix: Reference Documents