- 01 Explainable
- The people relying on a system must be able to see why it’s approved: what it’s for, the evidence, the assumptions, its known limits, and who owns it.
- 02 Challengeable
- A clinician, operator, patient advocate, or reviewer must be able to challenge a result, or how people are using the system, through a set route, without needing to know someone.
- 03 Correctable
- When evidence, policy, performance, or operating conditions change, the institution must be able to review the system, make a new decision, and carry the correction to every workflow it affects.
- 04 Refusable
- People must be able to decline or withdraw without penalty or permission from the buyer or operator. Before approval, name who will provide care if a patient declines the tool and how the patient can reach them. The institution must staff that route and cover the work it adds. Record when someone declines.