Clinical AI Governance — Authority, Boundaries, Enforcement, Auditability

Clinical AI governance is not about model intelligence - it's about who is authorized to act, when, and under what constraints.

This framework defines how execution is governed at runtime, how boundaries are enforced, and how accountability is provable before clinical claims are made.

Governance applies across all phases of AI deployment - from non-medical to SaMD readiness and regulated clinical AI.

For a high-level view of how authority is phased and matured, see the Governance Roadmap.

Core Pillars of Governance

Authority Inventory

All clinical decisions that may be influenced by AI are documented
Human authority holders are named and revocable
Authority is assigned before execution is permitted

Boundaries & Permissioning

Permitted actions are defined in advance
Anything outside scope is refused by default
Expansion requires human re-authorization

Runtime Enforcement

Policy-constrained actions enforced through a governance control layer (Safety OS)
Mandatory refusal when boundaries are exceeded
Structured escalation to humans

Auditability & Traceability

Actions, refusals, escalations, and authority assignments are continuously logged
Logs are immutable, time-stamped, and attributable
Supports regulatory traceability, incident review, and post-market surveillance

Governance Sequencing: How Safety OS Enables SaMD Without Clinical Delegation - showing Phase I Non-Medical AI, Phase II Physician-as-Pilot, Phase III Regulated Clinical AI (SaMD), with authority maturity (not intelligence) arrow and invariant: clinical authority is never delegated to AI

Safety OS Governance Architecture. This conceptual diagram illustrates how a governance layer enforces boundaries, constrains actions, and generates immutable audit evidence under continuous human oversight. This is architecture - not a product or clinical claim.

What This Governance Model Is Not

Not autonomous clinical decision-making
Not a claim of FDA or EU MDR approval
Not standalone software with clinical claims
Not diagnostic or therapeutic in any phase before regulated clearance

Regulatory Alignment

Governance Capability	Regulatory Relevance
Authority Inventory	Clinical evaluation alignment
Runtime Enforcement	Supports QMS and traceability
Auditability	Post-market surveillance & PMS
Permission Constraints	SaMD risk management expectations

References to FDA/MDR are descriptive; they do not imply clearance or endorsement.

In Practice

This governance model ensures:

Named authority for every potential clinical action
Boundaries enforced deterministically at execution time
Escalation to human authority only
Immutable evidence suitable for regulatory review

Understanding governance concepts leads naturally to how they work in practice.

→ See the Physician-as-Pilot operating model

For concrete examples of governance implementation:

→ Evidence & Implementation Library

← Back to PatientCentricCare overview

The Clinical Boundary ("Hand-Off Threshold")

Clinical inference is not permitted in Phase I. The threshold for diagnostic or therapeutic output is gated behind regulatory authorization and physician-supervised workflows in subsequent phases.

AI Act Alignment

Phase I logging architecture aligns with traceability principles under AI Act Article 12 (record-keeping and technical documentation).

This does not constitute a compliance claim. "Aligned with" indicates architectural intent, not certified conformity.

EU MDR Scope

Phase I is designed to operate outside the scope of EU MDR (2017/745) by explicitly excluding medical intent, diagnosis, and therapeutic recommendation.