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In order to bring consistency and to maximise the smooth use of ICT by healthcare actors in the creation, representation, analysis and interoperable communication of health information, it is important that the various standards used to represent health information are as best aligned as possible. 

ISO 13940:2015 (Contsys) defines a comprehensive concept model that applies to all aspects of clinical and patient workflows, and should therefore be the overarching domain model for the development of clinical information models. 

ISO 13606 (EHRcom) defines a high-level interoperability framework, including an information model, for the communication of electronic health record information. It includes the archetype concept, which is a dominant formalism for representing clinical information models. Part 3 of this latter standard includes an intersection of the two standards, by defining a set of clinical reference models as “reference archetypes” derived from ISO 13940, which are the clinical information models corresponding to the most frequently used clinical concept models, that might be represented within persisted clinical information.

HL7 FHIR is rapidly becoming the most supported interoperability interface specification for the communication of health information, including clinical information. It also has a specialisation mechanism, through FHIR Resources, that would allow for the equivalent representation to clinical information models, as interface specifications.

These three standards environments are therefore probably the most important to align in order to allow accelerated development and adoption of sophisticated clinical information systems and of better interoperability between them.

1) What we intend to do:

The primary aim is to give the HL7 FHIR resources a conceptual, clinical context and clinical process foundation based on ISO 13940:2015 Health informatics -- System of concepts to support continuity of care (Contsys). A secondary aim is to harmonize the HL7 FHIR resources with reference information structures (CRIS) and reference archetypes in EN/ISO 13606-3:2019 Health informatics -- Electronic health record communication -- Part 3: Reference archetypes and term lists (13606-3).

The work will be done in three steps. 

  1. For each FHIR resource identify which concept or concepts as defined in Contsys that the resource is specifying information about. Suggest a text to add to the description of the resource about the related concept/concepts. Also relate the interpretation of the concept behind the FHIR resource in Contsys diagrams. 
  2. For each FHIR resource, based on the identified concept make a gap analysis and identify discrepancies between the attributes in the FHIR resource and the attributes in the related CRIS. Suggest if the identified gaps should be resolved by e.g. adding/changing an attribute to the resource or by creating an extension to the resource.
  3. Based on analyses the marked concepts in the Contsys models identify need for and suggest new or needed changes/extensions of existing FHIR resources.  The analysis should include if there is any clinically important concepts or characteristics in Contsys that has no corresponding FHIR resource for information. The analysis should also identify if there is more than one FHIR resource needed to apply for information concerning one concept. If found needed and relevant also suggest a solution for harmonization between concepts for clinical content and clinical context expressed in Contsys and capacity for information specifications applying FHIR resources.  

2) Assistance we need from HL7 FHIR experts:

The project team should be built up by experts from the three standards (ISO 13940, ISO 13606 and HL7 FHIR). Clinical competences should be included in all phases. The experts should have experience from development of the standard to be able to participate in the work and do the analysis, interpretations, comparisons and to suggest appropriate solutions where the standards is in disharmony. For HL7 FHIR is needed knowledge/experience for the development and need analyses behind the resources and extensions. For ISO 13606 is corresponding requirements concerning the Clinical Reference Information Structures and the reference archetype needed. For Contsys is knowledge concerning the reasoning behind the selection and definition of the concepts and how these relate to each other needed.

3) What we intend to develop/ballot/publish (as HL7 and ISO TC215 products)?

  • Project report including mapping tables in both directions between HL7 FHIR resources and ISO 13940 and ISO 13606 (HL7 and ISO TC215 product)
  • Description for each FHIR resource where the related Contsys concept or concepts is described (proposed to be published on the respective HL7 FHIR resource content page.) (HL7)
  • Based on the results of the analysis
    • ISO 13606/ISO 13940/FHIR Implementation Guide, including FHIR profiles and extensions (HL7 and ISO TC 215 product)
    • Suggestions for change to existing FHIR resources and elements, as needed (HL7)
    • Suggestions for new FHIR resources, as needed (HL7)
    • Suggestions for change in upcoming periodic reviews in ISO 13606 and ISO 13940 (ISO TC 215 products)

The ISO Companion Project is ISO 24305 (ISO TC215 WG1).

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