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Definition

CARE-IT is a domain-specific reference model for the governance and operational management of clinically relevant digital clinical infrastructure within healthcare institutions.

It defines a structural framework that ensures digital decisions are consistently aligned with clinical effectiveness, while systematically addressing operation, risk, and responsibility allocation.

CARE-IT is:

  • not a product
  • not a certification
  • not an IT service management framework
  • not a regulatory standard

CARE-IT is a structuring leadership and governance model.

Core Function​

CARE-IT establishes a binding decision logic for digital systems that:

  • are intended to support clinical effectiveness,
  • may generate patient-relevant risks,
  • require long-term operational sustainability,
  • are embedded within complex clinical system constellations.

It ensures that digital infrastructure is governed not in technical isolation, but systemically and in alignment with clinical capability.

Object of Application​

CARE-IT does not evaluate individual software products or devices.

It evaluates digital clinical infrastructure as a clinical system constellation.

A clinical system constellation includes:

  • clinical application systems,
  • medical devices,
  • interfaces,
  • data flows,
  • organizational responsibility allocation,
  • operational processes.

The unit of evaluation is not the individual product, but the effectiveness-relevant overall system.

Structural Components​

CARE-IT consists of:

  1. Eight foundational principles (normative guidelines)
  2. A two-level maturity model
  3. Six structural domains
  4. A defined artifact architecture
  5. An implementation and governance logic

These components are structurally interconnected.

Objective​

CARE-IT aims to structurally enable organizations to:

  • prioritize digital decisions according to clinical effectiveness,
  • assign responsibility explicitly,
  • manage risks consciously,
  • ensure long-term lifecycle sustainability,
  • integrate innovation within a defined normative boundary.

CARE-IT does not replace existing models.
It provides a connecting reference framework between clinical governance, technical implementation, and organizational oversight.

CARE-IT is a reference framework for structural decision capability in digital clinical operations.