View source for CARE-IT Reference Library:Methodology

== Introduction ==
The CARE-IT Reference Library is a curated knowledge graph describing clinical digital infrastructure.

Its purpose is not to replace existing healthcare terminologies or interoperability standards. Instead, it provides the architectural and governance context required to understand how clinical capabilities are realised through digital systems operating in healthcare organisations.

The methodology is based on the principle that digital healthcare should be described using internationally recognised concepts wherever possible, while explicitly modelling the relationships between clinical work, technology and organisational responsibility.

= Design Principles =

== 1. Reuse before invent ==
The library adopts existing international standards whenever suitable concepts already exist.

Examples include:

* SNOMED CT for clinical concepts and procedures
* LOINC for observations
* HL7 FHIR for interoperability resources
* openEHR for clinical information models
* IHE Integration Profiles for interoperability workflows
* ISO and IEC standards where applicable

New concepts are introduced only when no suitable international reference exists.

== 2. Capability-centred modelling ==
Clinical capabilities are the primary organisational unit of the library.

Technology is not considered an objective in itself.

Instead, applications, medical devices, integrations and information models are described according to the clinical capability they enable.

This approach keeps the focus on healthcare delivery rather than individual software products.

== 3. Knowledge graph instead of document hierarchy ==
Knowledge is represented as interconnected entities rather than isolated documents.

Each entity maintains explicit relationships to other entities.

For example, a Clinical Capability Profile may reference:

* a Clinical Domain
* SNOMED CT concepts
* participating professional roles
* required applications
* medical devices
* interoperability standards
* regulations
* governance responsibilities
* associated risks

This allows knowledge to be explored from multiple perspectives.

== 4. Governance as first-class knowledge ==
Successful digital healthcare depends not only on technology but also on governance.

The library therefore models organisational concepts including:

* ownership
* operational responsibility
* lifecycle management
* information governance
* operational readiness
* regulatory accountability

Governance concepts are treated as reusable knowledge objects rather than implementation details.

== 5. System constellation perspective ==
Clinical capabilities are typically realised through multiple interacting systems rather than individual applications.

The library therefore documents system constellations instead of isolated products.

A system constellation may include:

* clinical applications
* medical devices
* integration engines
* identity services
* communication services
* infrastructure components

The constellation, rather than any individual component, represents the operational capability.

== 6. Vendor-neutral modelling ==
The library describes capabilities, architectures and standards independently of commercial products.

Vendor-specific implementations may be documented as examples but do not define the underlying concepts.

== 7. Evidence and traceability ==
Statements should, whenever possible, reference recognised standards, regulatory documents or authoritative publications.

Every important concept should remain traceable to its original source.

= Information Model =
The CARE-IT Reference Library is organised around reusable knowledge objects.

Examples include:

* Clinical Domains
* Clinical Capabilities
* Clinical Capability Profiles
* System Constellations
* Applications
* Medical Devices
* Professional Roles
* Standards
* Regulations
* Risks
* Governance Concepts

Each object is uniquely identifiable and connected to related entities through explicit relationships.

= Scope of the methodology =
The methodology focuses on describing '''how clinical capabilities are enabled, governed and operated''' within digital healthcare environments.

It intentionally complements existing clinical terminologies and interoperability standards rather than replacing them.

= Continuous evolution =
The methodology will evolve as healthcare standards, technologies and governance models develop.

Changes are made conservatively to preserve consistency, interoperability and long-term maintainability of the knowledge graph.