Table 1 Risk levels and mitigation strategies

Risk Level 1: Minimal Risk

No requirement for providing evidence or for linkage to care. For example, apps aimed at supporting mindfulness practices would fall into this category

Risk Level 2:

Some Risk

Requires some research support regardless of the experimental design. The app should also leverage an evidence-informed theory to guide its approach. Additionally, it should facilitate remote sharing of information with a provider and provide the user with information on a crisis hotline or other resources. For minors, developmentally disabled adults, and older adults who have become incapacitated, the app should require legal guardian or caregiver permission and facilitate sharing of information with them

Risk Level 3

Considerable Risk

Requires research support with at least one or more randomized controlled trial that show evidence of impact. The app should also leverage an evidence-informed theory to guide its approach. Additionally, it should facilitate remote sharing of information with a provider and provide the user with information to access a crisis hotline or other resources. For minors, developmentally disabled adults, and older adults who have become incapacitated, the app should facilitate sharing of information with a legal guardian or caregiver