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Responsibility & Governance Matrix

Purpose​

The Responsibility & Governance Matrix creates explicit transparency
regarding who carries responsibility for clinical impact, regulatory operator accountability, integration, and risk.

It prevents diffusion of responsibility across disciplines and organizational boundaries.

The matrix makes structural accountability visible —
independent of individual persons.

Regulatory operator responsibility cannot be delegated to vendors, manufacturers, or technical service providers.

Guiding Question​

Who carries which form of responsibility for this system?

Structural Effect​

The matrix:

  • distinguishes clinical purpose responsibility from regulatory operator responsibility (the healthcare provider’s legally accountable responsibility for operating clinical systems)
  • makes integration responsibility explicit
  • clarifies decision authority and accountability
  • defines escalation pathways
  • stabilizes governance structures across domains

It operationalizes P3 – Transparent Allocation of Responsibility.

When Is It Applied?​

  • Introduction of new systems
  • Definition or revision of governance structures
  • Organizational changes affecting roles
  • Clarification of escalation logic
  • Audit, review, or regulatory assessments
  • Constellation-level responsibility alignment

The matrix should be reviewed whenever system scope, constellation structure, or governance arrangements change.

Typical Misapplications​

  • Informal role assumptions without documentation
  • Equating project leadership with long-term system responsibility
  • Undefined escalation pathways
  • Person-dependent accountability
  • Collapsing clinical and regulatory operator responsibility into a single role

Responsibility is not implicit.
It must be structurally defined and traceable.

Relation to Principles and Domains​

Primary alignment:

  • P3 – Transparent Allocation of Responsibility
  • D3 – Responsibility & Governance

Secondary alignment:

  • P5 – Patient Safety as Normative Boundary
  • D1 – Clinical Orientation & Benefit Governance
  • D2 – System Architecture & Constellation Governance

The matrix strengthens structural accountability across the clinical system constellation.