HL7 CMHAFF Standard Introduction and Purpose

3. Conformance Criteria, Resources, and Implementation Guidance

General Considerations, Product Development, and Support

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Each section (e.g., 3.2.x) is a category of criteria that follows a common format. First, there is a brief non-normative description of the category. Then there is a subsection containing a normative table of conformance criteria. Some criteria are applicable to all consumer health apps and other criteria are to be applied conditionally based on the functionality and scope of an app.

3.2.3 Usability & Accessibility

Health App Risk Management

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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.

3.3 Download and Install App

Quality, Safety, and Security

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Apps are frequently marketed and downloaded through platform-specific “app stores.” Before an app can be housed within an app store, it must meet requirements set by the app store host. The app store is one primary source of product information for consumers to decide whether they want to install the app. In some realms, apps may also be obtained through an app registry.  

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