1. WP1: D 1.3 Standards Framework Status June 25, 2015
William Goossen (NEN;
Christian Hay (NEN; )

2. 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

3. 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

4. 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

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

6. 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

7. 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.

8. 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

9. 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

10. Communication Systems, Profiles, Messages
HL7 EHR-S FM, IHE Medication Profile, ISO 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

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

12. 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