1. ECO R European Centre for Ontological Research Formal Ontology and Electronic Healthcare Records: what exists... what happened... what has been recorded... Werner Ceusters European Centre for Ontological Research Universität des Saarlandes Saarbrücken, Germany

2. ECO R European Centre for Ontological Research A visit to the operating theatre Haydom Lutheran Hospital, Tanzania This surgeon This amputatio n stump A lot of objects present This mask This hand with some relations Part of

3. ECO R European Centre for Ontological Research A visit to the operating theatre Haydom Lutheran Hospital, Tanzania This wound being closed by holding... That wound fluid drained A lot of processes going on This kocher being held in that hand of that surgeon with some relations Part of

4. ECO R European Centre for Ontological Research “Axiom” 1 If the picture is not a fake, we (i.e., me and this audience) KNOW that that hand, that surgeon,... EXIST(ed), i.e. ARE (were) REAL. But importantly: that hand, surgeon, kocher, mask,... EXIST(ed) independent of our knowledge about them and also the part- relationship between that hand and that surgeon, and the processes going on, are (were) equally real. epistemology ontology

5. ECO R European Centre for Ontological Research But there is also communication Haydom Lutheran Hospital, Tanzania I must get rid of that blood Suction, please ! He wants me to remove that blood Fluid being removed

6. ECO R European Centre for Ontological Research Give me a kocher, please. = ? Issues in communication

7. ECO R European Centre for Ontological Research Concept-based Terminology kocher

8. ECO R European Centre for Ontological Research “Axiom” 2 Concept-based terminology (and standardisation thereof) is there as a mechanism to improve understanding of messages, originally by humans, now also by machines. It is NOT the right device to explain why reality is what it is, how it is organised, etc., (although it is needed to allow us to communicate on insights thereof).

9. ECO R European Centre for Ontological Research Why not ? Does not take care of universals and particulars appropriately Concepts not necessarily correspond to something that (will) exist(ed) – Sorcerer, unicorn, leprechaun,... Definitions set the conditions under which terms may be used, and may not be abused as conditions an entity must satisfy to be what it is Language can make strings of words look as if it were terms – “Middle lobe of left lung”...

10. ECO R European Centre for Ontological Research Border’s classification of medicine Medicine – Mental health – Internal medicine Endocrinology – Oversized endocrinology Gastro-enterology... – Pediatrics –... – Oversized medicine

11. ECO R European Centre for Ontological Research There is record keeping too “Cavity drained and wound closed in layers”

12. ECO R European Centre for Ontological Research “Axiom 3” The health care record is a mixture of – Statements about portions of reality The person being cared Activities carried out Believes, desires,...... – Statements about statements When registered By whom...

13. ECO R European Centre for Ontological Research CEN’s view on reality and the healthcare record CEN ENV 13606 “The real world of health and health care is made up of individual clinical situations (of which the participants are called “associate topics”), that are described by an EHCR author as clinical statements. Within an EHCR system each clinical statement will be expressed as an elementary healthcare record entry.”

14. ECO R European Centre for Ontological Research EHR Extended Architecture Architectural Component Root Architectural Component Record Component Original Component Complex Selected Component Complex Data Item Link Item Folder Headed Section Composition Cluster Data Item Specialisation Data Item Specialisation Data Item Specialisation Data Item Specialisation Elementary healthcare record entries CEN ENV 13606

15. ECO R European Centre for Ontological Research Types of Original Component Complexes OCC specialisation DescriptionExamples of Component Names FolderHigh-level subdivisions of the entire EHCR for a patient, usually grouping entries over long time-spans within one organisation or department, or for a particular health problem GP Record Inpatient Stay Diabetes Care Record CompositionA set of record entries relating to one time and place of care delivery; grouped contributions to an aspect of health care activity; composed reports and overviews of clinical progress Consultation Operation Notes Discharge Summary Vital Signs Chart Headed Section Sub-divisions used to group entries with a common theme or derived through a common healthcare process Past Medical History Presenting Symptoms Examination Findings Treatment Plan ClusterLow-level aggregations of elementary entries (Record Items) to represent a compound clinical concept Heart Sounds Differential White Cell Count Insulin Schedule CEN ENV 13606

16. ECO R European Centre for Ontological Research Architectural Component Attributes CEN ENV 13606 Architectural Component unique identifier Originating Healthcare agent Originating date and time Related healthcare agent Related date and time Component name structure Subject of care identifier Component Status information Distribution Rule Reference Language 1 1 1 0..n 1 1 1 0..1 Refer to situations and statements and rely on terminology

17. ECO R European Centre for Ontological Research Component Name Structure Each instance of Architectural Component shall be associated with a component name. The name may be expressed as a simple code, a structured set of codes or, in certain circumstances, as a string. NOTES: – This attribute is used to provide the Architectural Component with a descriptor, title, heading, label, etc. depending upon the deployment of the Architectural Component. – The component name may be a term drawn from a domain information model. – Limiting the use of textual names to EHCR Root Architectural Component, Folder OCCs and SCCs is recommended, although these too may utilise coded names. CEN ENV 13606

18. ECO R European Centre for Ontological Research Semantic categories and “fine-grained descriptors” clinical situation condition or state normal condition abnormal condition Illnessdialyzed Comacardiopathic Deathcarrier of prosthesis Diabeticwound infection healthy carrier of disease allergy state symptom sign disease lesion injury impairment CEN ENV 13606 To be used in healthcare records as an alternative to terminologies

19. ECO R European Centre for Ontological Research “Archetypes” clinical situation –pertains tobody component, product, environment –has context facet subject of information, process status, role for dates –has information qualifierknowing mode has information sourceactor has qualifiercommunication modality –has qualifierrelevance –has role role for clinical situation Is stated by actor, healthcare organisation has temporal marker timing marker CEN ENV 13606 To be used to build terminologies that may be used for the EHR

20. ECO R European Centre for Ontological Research Reference Information Model HL7 Entity Language Communication Function Role Participation Act Context Structure Role Link ActLink Living subject person nonPersonLS Place Organisation Material ManufacteredM Device Container Employee Patient LicensedEntity Access Managed Participation PatientEncounter ControlAct Supply Diet WorkingList Procedure Observation PublicHealthcare DiagnosticImage DeviceTask SubstanceAdministration FinancialContract Account FinancialTransaction InvoiceElement

21. ECO R European Centre for Ontological Research “Axiom” 4 EHR standards should make better difference between language, terminology and communication issues on the one hand, and ontological issues on the other hand

22. ECO R European Centre for Ontological Research “Axiom” 5: A need for a clean separation of knowledge AND ontology Conceptual knowledge: the knowledge of sensible domain concepts Knowledge of definitions and criteria: how to determine if a concept applies to a particular instance Surface linguistic knowledge: how to express the concepts in any given language Knowledge of classification and coding systems: how an expression has been classified by such a system Pragmatic knowledge: what users usually say or think, what they consider important, how to integrate in software Alan Rector Ontology: what exists and how what exists relates to each other