WP1: D 1.3 Standards Framework Status June 25, 2015 William Goossen (NEN; wgoossen@results4care.nl) Christian Hay (NEN; christian.hay@gs1.ch )

Task 1.3 (M4 – M9) Identify a common set of descriptive attributes used to specify a medicinal or pharmaceutical in a way that it is identified Assess outcomes of T1.1 on gaps with standards to enable interoperable exchange of medication related information, e.g. periodicity, frequency, strength, route of administration, pharmaceutical form, administration form etc… Propose a standard infostructure related to medicinal and/or pharmaceutical products and based on existing standards enabling identification as well as description of the pharmaceutical products. An ‘infostructure’ is defined by the SemanticHealthNetwork project as “a formal process for the governance of interoperability resources”. It can be defined as the infrastructure to manage “information resources”. This infostructure is a rather theoretical model. D1.3 Initial openMedicine infostructure

D1.3: Standards Framework TOC 1. Executive Summary 2. Introduction 3. Methods 4. Conceptual level overall standards framework 5. Medicinal and Pharmaceutical Products Related Standards 6. Information standards / specifications for medicinal product identification 7. Dictionaries, Terminologies and Codes for Medicinal Products 8. Contexts Standards for Exchange of Medicinal Product Identifiers 9. TODO: Proposed Solution Medicinal Product Identifier in EHRs & epSOS 10. TODO: Discussion and Conclusion 11. Bibliography 12. To be removed here and place in WP 1 glossary 13. Annex 1 Specification of the Medicinal Product as DCM. 14. TO DO: Annex 2 Product identifier specified in HL7 v3 XML

D 1.3. Standards Framework Use Generic Component Model as baseline Domain n Domain 3 Domain 2 Domain 1 Enterprise View Information View Computational View Engineering View Technology View System Component Composition System Domain System Viewpoint Business Concepts Relations Networks Aggregations Details

Identification of Medicinal Products IDMP The Key Source! No Escape for anyone!

ISO TS 19256 Medicinal Product Dictionary Holds and uniqely identifies actual regulated medicinal products within jurisdictions Will be the source of the IDMP based identifiers

ICSR Implementation Guide for Europe Has pre-defined fragments in HL7 v3 message for implementation Re-usable for openMedicine after completion EU Individual Case Safety Report (ICSR)0F Implementation Guide European Medicines Agency. Publication EMA/51938/2013.

Create a full Detailed Clinical Model 4. Meta information: Author Coder Versioning 1. Medical knowledge: concept, target population, evidence, instruction, interpretation 2. Data elements 3. Unique codes, Snomed CT etc 5. Governance

Medicinal Product DCM Under Construction To do: 1. underpinning, 2 check with HL7 Common Product Model, 3. unique code for each ? In model Snomed CT? EMA? 4. express as HL 7 v3 template, 5.OID assignments

Communication Systems, Profiles, Messages HL7 EHR-S FM, IHE Medication Profile, ISO 13606 etc EHR-S FM Compositions Set of entries comprising a clinical care session or document e.g. test result, letter EHR The electronic health record for one person Folders High-level organisation of the EHR e.g. per episode, per clinical speciality Sections Clinical headings reflecting the workflow and consultation/reasoning process Clusters Compound entries, test batteries e.g. blood pressure, full blood count Elements Element entries: leaf nodes with values e.g. reason for encounter, body weight Data values Date types for instance values e.g. coded terms, measurements with units Entries Clinical “statements” about Observations, Evaluations, and Instructions IHE Medication Management, Concepts and Definitions New work item proposal 13606-1

Context: Contsys & Architecture System of concepts for continuity of care ISO 13940 (Oughtybridge, 2014).

Conclusions Appropriate identifiers => ISO IDMP series Enable use of IDMP => Detailed Clinical Model (DCM) DCM Medicinal Product => core for systems, processes, and communications (Completion in WP 2, D2.3) standards framework => various contexts & issues identified and manageable