IT-tillämpningar

ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017. Medicinal products for veterinary use are out of scope of ISO 11616:2017.

This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

This document defines cyber security requirements for products with digital elements belonging to product category “application on the Smart Cards, Secure Elements, and similar devices” (hereinafter called “Product”). It extends the prEN 50764:2026, which defines the cyber security requirements for the platform underneath the application.

All products with digital elements having the form of a Smart Card or any similar device, where application is not installed on a platform defined by prEN 50764:2026 are excluded from the scope of this document.

More details about the product context in scope is given with Clause 4

The scope of this standard is to define a nomenclature for communication of information from point-of care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object oriented information model that is for medical device communications. This amendment extends IEEE Std 11073-10101-2019 to include additional terms primarily related to infusion pumps, ventilators, dialysis and other key medical devices as well as event and alert identifiers for devices and systems used in acute care

The standard specifies a data model in UML and a derived XML schema (XSD) for defining the Level of Information Need in software applications based on concepts and principles given in Part 1, and guidance given in Part 2, in compliance with the principles and data exchange standards of data templates (ISO 23387). The standard defines the exchange format schema in XSD according to the UML schema and it gives guidelines for the usage and application of the schema. In addition, the integration with Linked Data principles and paradigms will be demonstrated.

This document defines a framework for assessing the quality of data governance and data management practices for participants in data spaces. It specifies the core principles, processes, and assessment elements that enable organizations to manage, monitor, and improve their data governance and data management practices. The framework comprises two components: • Process Reference Model: Defines key processes for data governance and data product management of data space participants, including its fundamental principles, structure, detailed process definitions, links to broader data governance, and required implementation measures. • Process Assessment Framework: Outlines a model to evaluate process capability by establishing six distinct quality levels expressed in terms of capability levels, describing the corresponding profiles and guiding the systematic assessment. This standard is aimed at supporting data governance and data management professionals, IT managers, quality assurance officers, and regulatory bodies. This standard is applicable to organizations of all types and sizes.