Standards › Standard 2D › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · AI-SOP-003 · Version 1.1 · Approved by the ASF Expert Committee
Supports: 2D.8
At a glance
- Tell each patient when an aspect of their care involves an AI system.
- Use plain language, on the patient information notice (AI-FRM-003).
- Record the disclosure in the patient file.
- Answer questions and offer a non-AI option where appropriate and possible.
- Stop and get help straight away if: a patient is not told about AI involvement in a decision that matters to their care.
1. Purpose
To make sure patients know when AI is part of their care, in words they understand, and can ask questions about it [E-011, EC].
2. Scope
| Applies to | Clinicians and staff who explain care to patients |
| Locations | All clinical areas using AI systems at the facility |
| When | Before or at the point of care involving AI; the notice reviewed yearly |
| Does not apply to | General consent forms, which follow the consent standard (SOP-118, generic) |
3. Definitions
| Term | Meaning |
|---|---|
| Disclosure | Telling a patient that an AI system has supported an aspect of their care |
| Plain language | Words a patient understands on first reading |
4. Background
Patients may assume every decision was made by a clinician alone. Disclosure is part of informed care, and it helps patients trust the care they receive. Criterion 2D.8 asks for disclosure as standard, not optional [E-011].
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Treating clinician | Tells the patient and records it | Clinical communication |
| Clinical lead | Approves the patient notice | Clinical |
| Patient information lead | Keeps the notice current and in the needed languages | Communications |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Patient notice on AI use (AI-FRM-003) | Current, plain language | Posted and given on request |
| Disclosure record in the patient file | Current | Held with the record |
7. Safety
- Disclosure must never delay urgent care.
8. Before you start
- Check the notice is current and available in the patient’s language.
9. Procedure
Step 1. Tell the patient.
- Before or at the point of care, tell the patient that an AI system supported part of their care, and what it was used for.
- Explain that a clinician made the final decision.
Key point: The clinician is the one who decides. Say so.
Step 2. Use the notice.
- Give the patient AI-FRM-003, in plain language and in the language they use.
Key point: A plain notice is what most patients will read.
Step 3. Answer questions.
- Answer the patient’s questions. Offer a non-AI route where it is clinically appropriate and possible.
Key point: Patients who ask deserve a clear answer, not a referral.
Step 4. Record.
- Record in the patient file that the patient was told and what was said.
Key point: The record is the evidence for the criterion.
Step 5. Review the notice.
- Review the notice yearly and after any change in AI systems.
- Ask a sample of patients whether they understood it.
Key point: Patients are the best test of plain language.
10. Decision points
- If a patient declines AI involvement, the clinician decides whether the non-AI route is clinically possible, and records the decision.
11. Special situations
| Situation | Action |
|---|---|
| Emergency care | Give the care first, then inform the patient as soon as it is safe, and record it. |
12. Escalation
- Complaints about disclosure go to INC-POL-002.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Patients told (sample of 10 records per quarter) | 100% | Quarterly | Clinical lead | Re-brief clinicians |
| Notice current and available in patient languages | Yes | Yearly | Patient information lead | Update within 30 days |
| Patients who can confirm they were told (sample) | At least 80% (EC) | Yearly | Clinical lead | Review notice |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| Disclosure entry in the patient record | Patient file | As the patient record (EC) |
| AI-FRM-003 Notice (current and superseded) | Patient information file | the period set by the facility’s records policy years |
15. Training
- Clinicians are trained in disclosure and in plain-language explanation at induction (EC).
16. Related documents
| ID | Title | Use |
|---|---|---|
| AI-FRM-003 | Patient Information on AI-Supported Care | Notice used in step 2 |
| AI-POL-001 | Responsible Use of AI in Care Policy | Parent policy |
| CON-SOP-001 | Informed Consent (Standard 1) | Consent process |
17. Evidence
| Reference | Note |
|---|---|
| E-011 | WHO (2021), Ethics and governance of artificial intelligence for health. Used as the basis for AI governance. Link and wording to verify before publication. |
| E-009 | ASF Expert Committee consensus. Sample size and patient languages to be agreed. |
18. Change history
| Version | Date | What changed | Approval |
|---|---|---|---|
| 1.0 | the date of approval | First version | Approved by the ASF Expert Committee |
| 1.1 | the date of approval | Internal quality review: corrected cross-references, status wording and document control | Approved by the ASF Expert Committee |
E-learning for this document
References
- World Health Organization (2021). Ethics and governance of artificial intelligence for health: WHO guidance. Geneva: WHO. Open source (E-011)
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)