2.4.1 Use Case A
Simple, Standalone
2.4.1 Use Case A
A walking app collects data based on how far someone walks, using GPS technology. A consumer can view a history of walks taken and summary statistics related to distance walked and estimated calories burned. App developer is not a HIPAA-covered (see reference below) entity (CE) such as a healthcare provider, nor is the app sponsored by a CE (such as a hospital or physician).
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Simple
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Medical Device App Categorization
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Wellness
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Data Device Categorization
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None
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PHI Data Storage
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Smartphone
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Data transmission by App
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None
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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
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More links
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For US Realm, FDA is the regulating agencySection 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.” Appendix B, which contains a list of apps that MAY meet the definition of medical device,