Authority
Assign initiate, modify, pause, override, abort and convert decisions.
System anatomy · 06
Human control and interface
Map clinician authority, feedback, critical tasks, automation surprises and emergency action in every mode.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
06
FUURAA thesis
A clinician-in-the-loop label is meaningful only when control, comprehension and response time are tested.
Engineering map
Turn the title into engineering objects that can be observed, measured and reviewed.
Each layer states the boundary to establish and the evidence needed for the next decision.
Feedback
Expose mode, state, uncertainty, force, delay, alarm and loss of function.
Critical tasks
Test realistic users under representative workload and environment.
Verification questions
Write the questions first, then decide whether a demo, test, pilot or operating record can answer them.
Each question needs an object, conditions, denominator, threshold and accountable decision owner.
- 01
Can the user detect the wrong mode?
- 02
What requires immediate action?
- 03
Can alarms be prioritised correctly?
- 04
Does training transfer to emergencies?
Evidence to preserve
Enable the next reader to reconstruct conditions, results, failures and the decision.
A conclusion alone loses reviewability; raw records, configuration and exclusions matter too.
- 01
Evidence package 1
Use-related risk analysis
- 02
Evidence package 2
Formative and validation study records
- 03
Evidence package 3
Mode and emergency-action test
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Expert users can still make predictable interface-induced errors; experience does not replace usability engineering.
- 02
This is an engineering reading and decision framework; it does not replace application-specific risk assessment, conformity work, procurement acceptance or professional advice.
Sources and evidence status
Read standards scope, measurement evidence and application conclusions separately.
Source dates and review status remain visible; external sources open in a new tab.
01
U.S. FDA · Updated 2026-08-03
↗02Applying Human Factors and Usability Engineering to Medical Devices
Frames safe and effective use around intended users, uses, environments, interfaces, critical tasks and validation of use-related risk controls.
U.S. FDA · Updated 2022-06-21 · verified 2026-08-15
↗03Computer-Assisted Surgical Systems
Explains authorised uses, clinician control, training, credentialing, facility responsibilities and adverse-event reporting for computer-assisted surgery.
ISO · Published 2019-12 · current edition verified 2026-08-15
↗ISO 14971:2019 — Medical-device risk management
Specifies a lifecycle process for identifying hazards, estimating and evaluating risk, controlling risk and monitoring control effectiveness.