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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

2.4.2 Use Case B
HL7 CMHAFF

2.4.2 Use Case B

Device-Connected Wellness App

2.4.2 Use Case B

A weight management app helps consumers to systematically collect weight information, food consumption information and exercise information.  Weight can be entered manually, or a consumer can link a wireless scale to the app so that weight is automatically collected when using the scale.  Food consumption is entered manually, and the tool estimates calories consumed based on the consumer’s input. Exercise information may be entered manually or collected automatically through integration with a smart watch. The app analyzes all the data and offers warnings and advice (e.g., patient’s unhealthy combination of weight and exercise levels lead to recommendations for diet and exercise changes): these make it potentially a medical device and candidate for government regulation, though not at this time.[See Link 1 Below] The app has an ability to download weight, activity, and food consumption information to PHRs through a published API. In the US Realm, the App developer is not a HIPAA entity, but app can be white-labeled by HIPAA entities, such as a clinic offering a PHR to its patients through a portal.

 

 

 Device Integrated

 Medical Device App Categorization

 Wellness

 Data Device Categorization

 Regulated Device

 PHI Data Storage

 Smartphone/PHR

 Data transmission by App

 Mid

 Importance of Data Integrity

 Low

 (USA) HIPAA covered?

 No, but Yes if white-labeled

 

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