1. catalogue, synthesise Templates, forms, data sets used in real, diverse health settings Formal representation of clinical business object REQUIREMENTS develop HL7 constraint formalisms develop and use import and export tools Formal HL7 constraint specification for static models Templates SIGM & M TC Agreed requirements for constraints Share with clinical and other non-HL7 communities Agreed approach with Terminfo and Clinical Statement

2. Archetype & Template requirements Definition Description sets Publication status Node constraints Term and concept bindings Attributes, associations and context Data value constraints References to EHR instances

3. Definition globally unique identifier id of repository maintaining this archetype health informatics domain (e.g. EHR) underlying RM concept (scope) code or phrase natural language parent archetype predecessor, reason for revision, successor

4. Description sets (multiple) providing party & organisation natural language scope: concept code, clinical speciality, types of patients, keywords intended use, potential erroneous uses reference to knowledge source (e.g. url) detailed explanation of purpose, notes url or references to explanatory materials

5. Publication status Tentative Draft Private Public Preferred Former Deprecated suggest adding Test date, authorising party & organisation review or validity date

6. Node constraints Explicit node Reference: to part or all of another archetype internal external constraints defining an inclusion or exclusion set

7. Explicit Node constraints internally-unique id Reference Model class inclusion or exclusion constraints (e.g. for existence, multiplicity) logical related to environmental parameters related to other EHR node values to be instantiated within the same archetype related to EHR instance data or workflow or care pathway processes

8. Binding to terms Principal concept (mandatory: the meaning) Term binding Synonym Language translation for each term: code, rubric, coding system and version, language in which mapping made

9. Attributes and associations common label attribute/association name optionality multiplicity if ordered if unique data value constraints other dependencies and constraints

10. Attributes and associations includes constraints on contextual information e.g. subject of information potentiality (present, absent, possible, probable, risk, goal, expectation, etc.) process (done, is in progress, is planned to be done, has not been done, should not be done, etc.)

11. data value constraints inclusion and/or exclusion criteria null, null flavour values default value fixed value list of values data type specific constraints e.g. value range, units, term set, date ranges logical conditions and other constraint rules (and formalism used)

12. References to EHR data (1) the archetype identifier the archetype node identifier the attribute or association name the occurrence in the instance hierarchy e.g. first, most-recent, any, n ordered by y, highest value, lowest value, one or more instances within a (definable) recent time interval

13. References to EHR data (2) the intended relationship between this specified instance value and the data value being constrained e.g. the same value as a subset or substring of greater than, greater than or equal to, less than, less than or equal to earlier than, later than, etc. if... then... must not be the same as

16. 13606-1 profile for archetypes

17. HL7 Templates draft 28 Feb 05 4.1 Template Architecture The Template Architecture that governs the normative HL7 V3.0 Templates must satisfy a series of requirements from the HL7 Standard V3 HDF Static Model: 4.1.1 Templates shall represent syntactically and semantically structured aggregation of data, including coded vocabulary or numerical data, as defined by domain experts or organizations. 4.1.3 The template architecture shall support structured aggregations of archetypes. 4.1.4 The template architecture shall support structured aggregation and composition of templates resulting in conformant Templates. 4.1.5 The template architecture shall support the re-use and import of archetypes into an authoring environment (including constraints expressed within those archetypes). 4.1.6 Templates may take the form of HL7-conformant balloted RMIMs, local information models or LIMs expressed in HL7-conformant structural notations, and HL7-conformant clinical document specifications. 4.1.7 An HL7 Template Library shall provide the ability to associate each template instance with relevant referenced HL7 specifications that contained within its components. 4.1.8 The HL7 Template Library shall provide the ability to query for all HL7 specifications components suitable for reference or inclusion in an HL7 Template 4.1.9 Registered HL7 V3 Templates shall include collected metadata about the Templates, such as the components that have been constrained. 4.1.10 Templates must allow for the recursive representation and traversal of associations in support of constructs with zero or more instances. Templates can include by reference other templates in an object oriented fashion.

18. HL7 Templates draft 28 Feb 05 4.2 Template Assertions The assertions of Templates as Static Models are governed by the HL7 V3 Standard HDF Static Model (3.2) requirements, including: 4.2.1 Static assertions. 4.2.2 Co-Occurrence Assertions Note that all co-occurrence assertions that are definitional shall result in the formation of new Static Model, in this case a particular kind of Template (termed an Archetype). 4.2.3 Containment assertions 4.2.4 Logic assertions 4.2.5 Mathematical assertions

19. HL7 Templates draft 28 Feb 05 4.3 Normative Template Representation The normative representation of HL7 Standard V3 Templates is governed by the HL7 Standard V3 HDF Static model requirements. The required UML examples are provided in Section 5.0. The particular view by specific metalanguages (XML, OWL, and ADL) is detailed below in the Technical Specifications provided in the annexes 4.4 Template Declaration When used in HL7 V3 instance: 1.Template ID (infrastructure root) is used to assert conformance to a Template. 2.Template ID asserts Template binding to an instance.

20. HL7 Templates draft 28 Feb 05 4.5 Templates Registration This section defines Templates registry and repository requirements. 4.5.1 Templates Repository... 4.5.1.2. The repository shall be capable of supporting hierarchical relationships among two templates. For example, if a series of Echocardiography Templates were represented, each applying tighter and tighter constraints, this hierarchy can be captured and queried in the repository....

21. HL7 Templates draft 28 Feb 05 4.5.2 Templates Metadata 4.5.2.1 Template ID 4.5.2.2 Name of the Template (required) 4.5.2.3 Description and scope of the Template (required) 4.5.2.4 Balloted rMIM fragment ID against which Template is developed (required) 4.5.2.5 Registering authority: organization, institution, committee, or individual (required) 4.5.2.6 Version number (required) 4.5.2.7 Publication state 4.5.2.8 Date of creation (required) 4.5.2.9 Date first in effect 4.5.2.10 Revision dates 4.5.3.11 Revision history 4.5.2.9 Date of expiration (optional) 4.5.2.10 Name of author, institutional affiliations(s) and contact information 4.5.2.11 Co-authors, institutional affiliations, and contact information (optional) 4.5.2.12 Technical contact 4.5.2.13 Administrative contact 4.5.3.14 Format (optional): e.g. rdfs: OWL, ebXML, and SR-XML 4.5.3.14 URI to documentation 4.5.3.15 URI of the package of templates

22. new cen work item proposal 1. An archetype ontology to map individual archetypes to a generic knowledge framework - to enable their use alongside other knowledge resources 2. Domain Base Concept Models, enabling sharable archetypes to be written 3. Rules about binding co-ordinated terminology values to archetype nodes (the TermInfo problem) 4. A rich library of archetypes conforming to the above, held within a public-domain repository 5. Guidance on how to map EHR system data conforming to each archetype to EN13606-1 (and other RMs)

23. proposals Formal representation of clinical business object REQUIREMENTS

24. proposals 1. Accept CEN archetype requirements (prEN13606-2, Annex A) as the requirements for formally representing clinical business objects in the Templates SIG, for communication with M&M 2. Agree that this clinical content synthesis work can be harmonised with CEN and openEHR, provided that no assumption is made about which Reference Model is to be used 3. Review CEN archetype model as a candidate for a data repository and authoring tools 4. Collaborate with M&M on mapping this to its evolving HL7 Template formalisms

25. catalogue, synthesise Templates, forms, data sets used in real, diverse health settings Formal representation of clinical business object REQUIREMENTS develop HL7 constraint formalisms develop and use import and export tools Formal HL7 constraint specification for static models Templates SIGM & M TC Agreed requirements for constraints Agreed approach with Terminfo and Clinical Statement develop guidelines & rules for good archetypes and templates Undertake as a joint project with CEN, openEHR, EuroRec