# Clinical AI Governance Framework — Implementation Workbook Version: 1.0 Published: 2026-07-27 Last updated: 2026-07-27 Owner: Rusaka Research Review frequency: Every 6 months ## Decision statement What decision must this workbook support? ________________________________________________________________________________ ## Scope and exclusions In scope: ________________________________________________________________________________ Out of scope: ________________________________________________________________________________ ## Baseline evidence register | Evidence item | Source | Date | Owner | Verified by | Status | |---|---|---|---|---|---| | | | | | | | | | | | | | | | | | | | | | ## Assumption register | Assumption | Rationale | Decision affected | Downside case | Test | Owner | Review date | |---|---|---|---|---|---|---| | | | | | | | | | | | | | | | | ## Options and decision criteria | Option | Outcome | Feasibility | Cost | Time | Risk | Reversibility | Recommendation | |---|---:|---:|---:|---:|---:|---:|---| | | | | | | | | | | | | | | | | | | ## Implementation plan | Phase | Entry evidence | Actions | Owner | Control | Exit evidence | Due date | |---|---|---|---|---|---|---| | 1. Discovery — Clinical AI Governance Framework | | During discovery, use Clinical AI Governance Framework to make comparable decisions with a consistent structure. Start with representative data, process volumes, error rates, human effort, current outcomes, and documented data rights. Name the accountable owner, the evidence reviewer, the decision deadline, and the output that proves this stage is complete. Record exclusions and unresolved questions rather than allowing them to disappear into narrative. The stage closes only when its evidence can be reproduced by someone who did not prepare it. | | | Required output: a completed framework, rationale, and exception register. | | | 2. Design — Clinical AI Governance Framework | | During design, use Clinical AI Governance Framework to make comparable decisions with a consistent structure. Start with representative data, process volumes, error rates, human effort, current outcomes, and documented data rights. Name the accountable owner, the evidence reviewer, the decision deadline, and the output that proves this stage is complete. Record exclusions and unresolved questions rather than allowing them to disappear into narrative. The stage closes only when its evidence can be reproduced by someone who did not prepare it. | | | Required output: a completed framework, rationale, and exception register. | | | 3. Pilot — Clinical AI Governance Framework | | During pilot, use Clinical AI Governance Framework to make comparable decisions with a consistent structure. Start with representative data, process volumes, error rates, human effort, current outcomes, and documented data rights. Name the accountable owner, the evidence reviewer, the decision deadline, and the output that proves this stage is complete. Record exclusions and unresolved questions rather than allowing them to disappear into narrative. The stage closes only when its evidence can be reproduced by someone who did not prepare it. | | | Required output: a completed framework, rationale, and exception register. | | | 4. Scale — Clinical AI Governance Framework | | During scale, use Clinical AI Governance Framework to make comparable decisions with a consistent structure. Start with representative data, process volumes, error rates, human effort, current outcomes, and documented data rights. Name the accountable owner, the evidence reviewer, the decision deadline, and the output that proves this stage is complete. Record exclusions and unresolved questions rather than allowing them to disappear into narrative. The stage closes only when its evidence can be reproduced by someone who did not prepare it. | | | Required output: a completed framework, rationale, and exception register. | | | 5. Operations — Clinical AI Governance Framework | | During operations, use Clinical AI Governance Framework to make comparable decisions with a consistent structure. Start with representative data, process volumes, error rates, human effort, current outcomes, and documented data rights. Name the accountable owner, the evidence reviewer, the decision deadline, and the output that proves this stage is complete. Record exclusions and unresolved questions rather than allowing them to disappear into narrative. The stage closes only when its evidence can be reproduced by someone who did not prepare it. | | | Required output: a completed framework, rationale, and exception register. | | ## Measures and thresholds | Measure | Definition | Source | Baseline | Target | Threshold | Owner | Frequency | |---|---|---|---:|---:|---:|---|---| | | | | | | | | | | | | | | | | | | ## Risk and control register | Risk | Cause | Impact | Preventive control | Detective control | Owner | Residual risk | |---|---|---|---|---|---|---| | | | | | | | | | | | | | | | | ## Review checklist - [ ] 1. Decision boundary: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 2. Stakeholder map: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 3. Current-state baseline: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 4. Evidence design: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 5. Operating model: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 6. Architecture and integration: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 7. Risk and compliance: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 8. Economics and value: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 9. Delivery sequencing: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 10. Vendor and partner assessment: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 11. Measurement system: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 12. Quality assurance: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 13. Change management: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. - [ ] 14. Documentation: evidence is linked, ownership is named, exceptions are recorded, and the current decision is clear. ## Approval record | Role | Name | Decision | Conditions | Date | |---|---|---|---|---| | Accountable owner | | | | | | Subject-matter reviewer | | | | | | Risk or control reviewer | | | | | ## Authoritative references - https://www.who.int/publications/i/item/9789240029200 — Authoritative reference 1 for the evidence and standards relevant to Industry AI Implementation. Confirm the current version and applicability before relying on it. - https://www.nist.gov/itl/ai-risk-management-framework — Authoritative reference 2 for the evidence and standards relevant to Industry AI Implementation. Confirm the current version and applicability before relying on it. - https://oecd.ai/en/ — Authoritative reference 3 for the evidence and standards relevant to Industry AI Implementation. Confirm the current version and applicability before relying on it. ## Related Rusaka resources - https://www.rusaka.com/resources/frameworks - https://www.rusaka.com/resources/guides/healthcare-ai-implementation-guide - https://www.rusaka.com/resources/guides/manufacturing-ai-guide - https://www.rusaka.com/resources/frameworks/fintech-compliance-framework - https://www.rusaka.com/resources/frameworks/supply-chain-ai-framework ## Important limitation This educational workbook does not replace legal, investment, tax, accounting, security, clinical, regulatory, or other qualified professional advice. Confirm current requirements and obtain formal organisational approval where applicable.