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.
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Device Integrated
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Medical Device App Categorization
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Wellness
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Data Device Categorization
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Regulated Device
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PHI Data Storage
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Smartphone/PHR
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Data transmission by App
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Mid
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Importance of Data Integrity
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Low
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(USA) HIPAA covered?
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No, but Yes if white-labeled
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More links
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1 - For US Realm, FDA is the regulating agency. Section V.A says that the following type of app IS within FDA oversight: “Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.”