Launch of App - Conformance Criteria
3.3.2 Launch App and Establish User Account
Nathan E Botts
/ Categories: 3.3.2 Launch App

3.3.2 Launch App and Establish User Account

Assisting the Consumer with Establishing Access


This category is about the process of a consumer getting started with an app, potentially including establishing an account.

Related Regulations and Standards

See Appendix: Reference Documents

Implementation Guidance

  • Use Case A: Knowing who the user is, in an absolute sense, is not needed as data is not being sent to any external data set. Primarily, account controls are in place to ensure the same person is using the app each time. For this walking app, possession of a smartphone may be sufficient to allow someone to use it without any additional need for authentication or need to set up a unique user ID and password to access the app.
  • Use Case B: Knowing the user’s absolute identity is not needed but minimal account controls (e.g., user ID and password) should be established as the app will allow information to be sent to an existing data set, and these data sets will need some ability to be linked, in part showing evidence an individual has control over both the app data and a right to access the existing data set.
  • Use Case C: requires more rigorous identity proofing as data will be both sent to an EHR and interactions initiated by a physician result in information being pushed to the app. Identity proofing can occur within the app itself, or in the use of pre-existing identity credentials (e.g., patient portal credentials for the entity controlling the EHR) to establish identity.
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Health App Launching Conformance Statements

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