Step 11 of 12Decision
Record the governance decision
Sign in to save your workRecord a proportionate, evidence-based decision. There is no automatically correct option; the decision must follow from the evidence and say what remains uncertain.
LEGAL AND REGULATORY TOUCHPOINTS
Points to raise with specialists
- Software that informs triage may be a regulated medical device in the UK; confirm its status and the supplier's obligations with the regulator's guidance.
- Clinical risk management standards for health IT expect a clinical safety case and hazard log, signed off by a Clinical Safety Officer, from both the manufacturer and the deploying organisation.
- Health data is special category data under UK GDPR; a DPIA is expected for high-risk processing.
- The hospital's duty of care and patient-safety incident reporting apply whether or not AI is involved.
- Equality: check whether performance differs by sex, age, disability or language.
- These are pointers for discussion, not legal or clinical advice.
Governance Decision Record
This leads your report.
Balance the benefit, the harm to affected people, the evidence available and the uncertainty that remains.
What did you see, not merely what you were told?
Assumptions and evidence gaps that could change the decision
What must be true for the decision to stand?
Measures, thresholds, review cadence and owners
Accountable role with authority
When the decision will be revisited
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