ISO/AWI TS 21405

Health Informatics — Identification of Medicinal Products — Methodology and Framework for the Development and Representation of IDMP Ontology ISO/AWI TS 21405

Scope

The TS will describe a standardized methodology in support of an open-source global adoption of the IDMP standards for the unambiguous identification of medicinal products in an ontological format. Realization of the full potential of IDMP requires fully self-describing data. For this purpose, we describe a methodology for an approach that will complement the existing standards and logical model with an IDMP Ontology that enables deep, semantic interoperability based on Findable, Accessible, Interoperable and Reusable (FAIR) data principles. This methodology shall enhance the usage of the IDMP data model as the foundation of medicinal product identification and will ultimately enable collaboration towards drug safety and overall operational efficiency.
This methodology enables deep, semantic interoperability based on FAIR data principles as a complement to the existing conceptual and logical models in the ISO IDMP standards and technical specifications. It also describes a methodology for the agile adaptation of IDMP standards in connection with cross-jurisdictional IDMP-related legislation and initiatives. This TS is intended to be complementary to and independent from formal regulatory guidance. Thus, it shall enable cross-jurisdictional consistency and support stakeholders in their regional implementations of IDMP standards.
The TS will include key use cases described in IDMP ISO 11615 and the DTS 6476 (Logical Model), as well as further use cases arising from the comprehensive deployment of the ISO IDMP standards via the ontological approach. Thus, this approach aims to cover the ISO IDMP standards regarding key interoperability issues that implementing stakeholders are facing.