PD CEN ISO/TS 19256:2017

Health informatics. Requirements for medicinal product dictionary systems for health care. | Status: Current

1 Scope This Technical Specification defines the required characteristics for any MPD-system to support use cases in healthcare. These characteristics include the medication concepts, identifiers and relationships to form a kind of structure that supports the use cases. In order to support the use cases, an MPD-system needs to:

• • be comprehensive and exhaustive as far as possible – unless all medicinal products that are in scope are included, other systems cannot fully rely on the MPD-system to supply the necessary information, and some amount of duplicated registration of information will still be necessary;
• • contain the information in a consistent and appropriate structure according to the ISO IDMP Standards (as described in this Technical Specification) and with an appropriate level of detail.

Outside the scope of this Technical Specification are:

• • the functionality of health, clinical and/or pharmacy systems;
• • the other kinds of content of health, clinical or pharmacy systems that are needed to support the whole process of healthcare providers, like:
  • ○ the wide range of knowledge about medicines, which would be handled in drug knowledge databases and decision support systems,
  • ○ the medication record,
  • ○ the dose instructions;

• • in terms of products:
  • ○ traditional Chinese medicines,
  • ○ medical devices, such as for medication administration [this Technical Specification focuses on administration devices that are intended for correct administration of the medicinal product only (see ISO 11615)],

    NOTE An administration device can be an integral part of an immediate container or a closure.

  • ○ veterinary medicines.

The purpose of this Technical Specification is to provide a set of functional requirements for systems handling details about medicinal products and the relationships between them for the purpose of supporting healthcare.