...
- Uniquely Identifies Mobile Health App Instance as installed on a Mobile "Device" and used by a specific person.
- Potential data elements
- Application name
- App Builder
- version
- build number
- hosting device
- unique identifier(s)
- Unique Device Identifier(s)for a Patient’s Implantable Device(s) - A unique numeric or alphanumeric code that consists of a device identifier (DI) and a production identifier (PI) -FDA approved device
- Does UMHAI change when new data generating devices are added to MH App linkage? Yes
- Need to define MH App State Diagram.
- Single User (keep it simple) - App has a point of access for a single user
- Differentiate but be able to consolidate data from same user using different app versions
- Multiple User/Single device - Single device is used by two or more users
- MH App Prescription is linked to UMHAI Identifier
- Screening Device - Anonymous Subjects need to have UMHAI defined even without subject information.
- Cardiac Screening EKG/ECG
- add Notes from meeting
- Data Retention Policy
- Subject/User Data
- UMHAI ID Authority (Does not exist today)
- ID Authority (Credentials/ Certificate/ App Store)
| Static (one time) | Sporadic Changes (infrequent changes) | Dynamic (frequent changes) | Comment: | UMHAI APIs |
|---|---|---|---|---|
App Name | App Version | Manufacture Provided | Get current UMHAI ID | |
| App Category | Needs Ontology for Mobile Health App categories , possibly realm specific | |||
App Demographics
| Hosting Environment
Linked Devices (Context)?
| App may need to be updated when OS Version is updated. Do we need to know about wearable or smart devices used by the app? | ||
| Subject/ User | User may not subject/ Clinical Use/ Public Health or Subject for healthcare Direct/ Indirect Use ( Parent/ Child/ Guardian/ Care Provider/ Custodian) | |||
| Context of use | Context of use | needs more discussion with use cases for Static or Dynamic Digital Therapeutics App Recall linked devices are supported or not supported | ||
| No PHI | No PHI | User will need some form of authentication (Biometric, Pin) |
UML Deployment Resources:
...