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HL7 CMHAFF Standard Introduction and Purpose
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.

Appendix B, which contains a list of apps that MAY meet the definition of medical device, for which FDA intends to exercise enforcement discretion. Examples include “Mobile apps that are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness…”

 

 

 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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