Project-derived · pre-deployment · sanitized

Pre-deployment Governance Charter (project-derived, sanitized)

The real governance charter I developed for the medical digital twin I am building. It defines the system as a non-diagnostic prototype and builds its governance in parallel, before any deployment.

What this artifact is for

Most governance failures start before a line of monitoring code is written: the intended use is vague, the boundaries are undefined, and nobody has decided what evidence is required before patients are involved. A pre-deployment governance charter fixes those things at the start. It states what the system is, what it is not, where its boundaries are, and which artifacts must exist before it can move toward a pilot.

This is drawn from the actual governance pack (v0.2) of the medical digital twin I am building at the HKU-Avnet Joint AI Laboratory. The system has not been deployed; that is precisely why this charter exists now. It is sanitized: partner names, individuals, and confidential detail are removed, and the structure and governance logic are the real ones.

Fixed metadata

Project definition and intended use

The initiative develops a non-diagnostic medical digital twin prototype with a parallel pre-deployment governance framework. The current system is an internal research demonstration. It is not a clinically validated or deployment-ready system, and it is not a diagnostic device. Its patient-facing purpose, when reached, is longitudinal explanation and escalation within a bounded scope, not autonomous diagnosis.

Scope of the governance workstream

1. Use-case and intended-use definition
2. Model boundary statement (what the system may and may not claim)
3. Data-readiness assessment
4. Clinical review workflow
5. Risk register and RACI
6. Incident escalation pathway
7. Post-market monitoring concept
8. Deployment-readiness criteria

Boundaries

• Clinical validation and patient-safety decisions require clinical reviewer / clinical PI approval, not the AI team alone.
• IP, licensing, spinout, and commercialisation require the relevant institutional, legal, and technology-transfer process.
• Any hospital deployment requires formal clinical, legal, and data-governance review before it proceeds.

Pre-deployment artifact set

Before the system can move toward an external pilot, this charter requires the following to exist and be reviewed: use-case definition, data-readiness checklist, model boundary statement, clinical review workflow, risk register, RACI matrix, incident escalation pathway, and a post-market monitoring concept.

The design principle

Governance is not a compliance layer added after the model works. It is built in parallel with the system, before deployment, so that intended use, boundaries, and accountability are decided while they can still shape the build, rather than reconstructed after something goes wrong. This charter is the instrument that makes “we will govern it later” into “here is what must be true before it reaches a patient.”

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