Werner Ceusters European Centre for Ontological Research Universität des Saarlandes

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

2. This surgeon with some relations Part of This mask This amputation stump This hand Haydom Lutheran Hospital, Tanzania A visit to the operating theatre A lot of objects present

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

4. epistemology ontology “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.

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

6. = ? Issues in communication Give me a kocher, please.

7. Concept-based Terminology kocher

8. “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. 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. Border’s classification of medicine • Medicine • Mental health • Internal medicine • Endocrinology • Oversized endocrinology • Gastro-enterology • ... • Pediatrics • ... • Oversized medicine

11. There is record keeping too “Cavity drained and wound closed in layers”

12. “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. CEN ENV 13606 CEN’s view on reality andthe healthcare record “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. Selected Component Complex Folder Architectural Component Composition Headed Section Original Component Complex Record Component Cluster Link Item Root Architectural Component Data Item Specialisation Data Item Specialisation Data Item Specialisation Data Item Data Item Specialisation CEN ENV 13606 EHR Extended Architecture Elementary healthcare record entries

15. OCC specialisation Description Examples of Component Names Folder High-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 Composition A 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 Cluster Low-level aggregations of elementary entries (Record Items) to represent a compound clinical concept Heart Sounds Differential White Cell Count Insulin Schedule CEN ENV 13606 Types of Original Component Complexes

16. Component unique identifier Language Related date and time 0..1 1 Component Statusinformation 0..n Related healthcare agent 1 Architectural Component 1 0..n Component name structure 1 Subject of care identifier Originating Healthcare agent 1 0..n 1 Originating date and time Distribution Rule Reference CEN ENV 13606 Architectural Component Attributes Refer to situations and statements and rely on terminology

17. CEN ENV 13606 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.

18. CEN ENV 13606 Semantic categories and“fine-graineddescriptors” clinical situation condition or state normal condition abnormal condition Illness dialyzed Coma cardiopathic Death carrier of prosthesis Diabetic wound infection healthy carrier of disease allergy state symptom sign disease lesion injury impairment To be used in healthcare records as an alternative to terminologies

19. CEN ENV 13606 “Archetypes” • clinical situation • pertains to body component, product, environment • has context facet subject of information, process status, role for dates • has information qualifier knowing mode • has information source actor • has qualifier communication modality • has qualifier relevance • has role role for clinical situation • Is stated by actor, healthcare organisation • has temporal marker timing marker To be used to build terminologies that may be used for the EHR

20. 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 Entity Role Participation Role Link ActLink Act Language Communication Communication Function Context Structure HL7 Reference Information Model

21. “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. “Axiom” 5: A need for a clean separation of knowledgeAND ontology Pragmatic knowledge: what users usually say or think, what they consider important, how to integrate in software Alan Rector Knowledge of classification and coding systems: how an expression has been classified by such a system 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 Conceptual knowledge: the knowledge of sensible domain concepts Ontology: what exists and how what exists relates to each other