The risk-benefit result enumeration defines the outcome of benefit-risk analysis performed on Risk Records where residual risk remains in the Investigation zone after all risk controls have been a
Benefit-risk analysis is only required when all three conditions are met:
Post-mitigation risk (postRisk) is Investigation (not Acceptable or Unacceptable)
No additional risk controls are practicable (additionalControlsPossible = No)
The device provides a clinical or functional benefit that may justify the residual risk
Three Risk Record fields work together to support benefit-risk analysis:
Field
ID
Type
Purpose
Benefit description
benefit
Rich text
Documents the clinical or functional benefit justifying residual risk acceptance
Benefit-risk result
riskBenefitResult
Enum (this field)
Captures the outcome: benefits outweigh risk, or not
Additional controls possible
additionalControlsPossible
Yes/No enum
Gates benefit-risk analysis — must be “No” to enable the benefit-risk path
The riskValueFinal formula in the risksheet implements a strict gate: if additionalControlsPossible is not explicitly set to "no", the final risk defaults to Unacceptable regardless of the benefit-risk result. This forces teams to confirm that all practicable risk reduction has been exhausted before invoking benefit-risk justification.
The benefit-risk result directly feeds into the Final Risk Classification via the riskValueFinal() formula:
Benefit-Risk Result
Final Risk
benefitAcceptable
Benefit-Risk Acceptable (purple styling in risksheet)
benefitNotAcceptable
Unacceptable
When the result is benefitAcceptable, the final risk receives the unique rpn4 purple cell styling in the HARA risksheet, visually distinguishing benefit-risk-accepted items from standard acceptable risks.
