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prEN ISO 13606-4 Public enquiry
Comment end date 2026-07-02
Health informatics - Electronic health record communication - Part 4: Security (ISO/FDIS 13606-4:2026)

This document describes a methodology for specifying the privileges necessary to access EHR data. This methodology forms part of the overall EHR communications architecture defined in ISO 13606-1. This document seeks to address those requirements uniquely pertaining to EHR communications and to represent and communicate EHR-specific information that will inform an access decision. It also refers to general security requirements that apply to EHR communications and points at technical solutions and standards that specify details on services meeting these security needs. NOTE Security requirements for EHR systems not related to the communication of EHRs are outside the scope of this document.

prEN ISO 11615 Archived
Comment end date 2026-05-22
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/DIS 11615:2026)

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

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