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Scope

CARE-IT defines the application domain of a governance and operational management model for digital clinical infrastructure.

The scope clarifies which systems, decisions, and organizational levels are covered by the framework — and which are not.

Within Scope​

CARE-IT applies to digital systems that:

  • influence clinical decision-making,
  • may generate patient-relevant risks,
  • are part of a clinical care process,
  • require sustained operation over time.

This includes, in particular:

  • clinical information systems (e.g., EHR, RIS, LIS),
  • networked medical technology systems,
  • monitoring and imaging systems,
  • integrated data platforms,
  • cross-system decision support,
  • interface and integration architectures.

CARE-IT does not evaluate the individual product, but the clinical system constellation in which it becomes effective.

Outside Scope​

CARE-IT is not:

  • a software development framework,
  • a project management standard,
  • an IT service management model,
  • an information security standard,
  • a regulatory approval procedure,
  • a medical device standard.

CARE-IT does not replace existing frameworks or regulations.

It addresses the structural governance logic above these layers.

Organizational Level​

CARE-IT operates at the level of:

  • executive leadership,
  • governance bodies,
  • clinical leadership,
  • medical technology management,
  • IT,
  • architecture and integration responsibility.

It is not a purely technical framework.

It is an organization-wide governance model for digital clinical infrastructure.

Decision Level​

CARE-IT primarily addresses decisions related to:

  • introduction of new systems,
  • integration into existing system landscapes,
  • operating models,
  • responsibility allocation,
  • risk assessment,
  • lifecycle planning,
  • transition of innovation into sustainable operation.

The scope ends where digital systems do not exert clinical relevance.

Context Dependence​

CARE-IT is scalable.

It can be applied to:

  • individual clinical system constellations,
  • departments,
  • entire hospitals,
  • hospital groups.

The depth of application depends on context.

The normative core remains unchanged.

CARE-IT does not define every detail of implementation.

It defines the structural conditions under which digital clinical infrastructure can be governed responsibly.