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2.4 Exemplary Use Cases

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.

HL7 CMHAFF Standard Overview and Use Cases

3.6.1 Health App Use Policies
CMHAFF Workgroup

3.6.1 Health App Use Policies

Responsible Terms, Conditions, and Agreements for Consumer Health Apps

Overview

Since one goal of cMHAFF is consumer protection, including their privacy and security, guidance in the area of “Conditions and Agreements” (CnA) is offered. CnA is not a formal or legal term, but an umbrella under which can be grouped various expressions of conditions that consumers to which are asked to agree before they start using a mobile health app. These may be called “Terms and Conditions,” “Terms of Use,” “Terms of Service,” “End User License Agreement (EULA),” and similar concepts.

Typically, CnA are displayed and consumers are asked to click buttons to agree to terms, when they interact with “App Stores” (a generic term including wherever a consumer downloads a mobile health app). In addition to what the consumer agrees to, CnA may also commit the app supplier to certain behaviors or restrictions.

While cMHAFF does not prescribe what these CnA must include, it provides guidance as to items that are important to disclose. In that respect, there is some precedent in the ONC 2015 Edition Certification, which contains disclosure and transparency requirements for EHR developers, e.g., about pricing and services that are not included in the base software.

 

Related Regulations and Standards

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