Risk-based design

Assurance profiles

Proposed profiles for risk discussion, not assurance levels under a certification scheme.

Choose controls for the action

Proposed profile	Context	Requirements
A / Convenience	Membership and assessed lower-risk presence use	Limited scope; registered device; profile-specific PAD; alternatives.
B / Enhanced	Patient, examination and controlled-access context	Established identity source; prefer 1:1 when a subject is known; contextual evidence; human review.
C / Sensitive action	Machine operation, restricted zones and privileged approvals	Additional factors; action binding; expiring grants; independent physical-safety controls.