HL7 CMHAFF Standard Sources of Regulations, Policies, Rules, and References

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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HL7 CMHAFF Glossary

Philosophically, the HL7 Mobile Health group favors using terms that are commonly accepted in the consumer mobile space, in preference to terms that are used only in the EHR space. Simply put, the target user for these devices are consumers, rather than clinicians. However, where terms are used differently in EHR vs consumer spaces, we take note of that, and acknowledge the various uses.

This does not purport to be an exhaustive set of mobile health definitions, but terms are included only to provide clarity within cMHAFF.

See British Standards Institution Publicly Available Specification (PAS) 277:2015 Health and wellness apps. Quality criteria across the life cycle. Code of practice (https://shop.bsigroup.com/forms/PASs/PAS-2772015/) which has a good set of Terms and Definitions (section 3).

Terms and Definitions

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