EN ISO/IEEE 11073-10472:2025 PDF

EN ISO/IEEE 11073-10472:2025 - Medication Monitor (ISO/IEEE 11073-10472:2024)

Overview

EN ISO/IEEE 11073-10472:2025 defines a normative communication profile for personal health device medication monitors to enable plug-and-play device interoperability with managers such as cell phones, PCs, personal health appliances and set‑top boxes. Within the ISO/IEEE 11073 family, this device specialization specifies the common core of communication functionality, leverages existing terminology, information models and transport/application profiles, and reduces optionality in base frameworks to improve interoperability in telehealth environments. The second edition adds features such as Base‑Offset‑Time support and updated association and configuration rules.

Key topics and technical requirements

• Normative communication definition between medication monitors and managers for reliable device communication.
• Use of standardized ISO/IEEE 11073 terminology, information models and application profile elements to avoid ambiguity.
• Specification of term codes, formats and behaviors required for medication adherence data exchange (restricting optionality to favour interoperability).
• Support for Base‑Offset‑Time and updated standard configurations based on it.
• Updated association details, qualifier recommendations (e.g., for MDS/DIM objects) and rules for DIM extensibility.
• Compliance and alignment with other parts of the 11073 family and related standards to ensure consistent semantics and protocol behavior.
• Examples and conformance guidance to assist implementation in telehealth scenarios.

Applications

This standard is directly applicable to implementations where medication adherence data must be collected, exchanged and interpreted across devices and software:

• Home and remote monitoring systems for medication adherence.
• Mobile health apps and gateways that receive data from smart pill dispensers, connected medication monitors and adherence sensors.
• Telehealth platforms and personal health management systems integrating adherence metrics into clinical workflows.
• Clinical trials and research where standardized, interoperable adherence data are required.
• Pharmacy services and care coordination platforms that aggregate patient medication-use data.

Who should use this standard

• Medical device manufacturers building medication monitors and connected adherence devices.
• Firmware and embedded software developers implementing the 11073 device stack.
• Mobile app and telehealth platform developers integrating personal health device data.
• Systems integrators, interoperability architects and healthcare IT vendors.
• Standards and regulatory professionals assessing conformance and device interoperability.

Related standards

• ISO/IEEE 11073 series (device communication and information models)
• ISO/IEEE 11073-20601 and IEEE Std 11073-10101 (protocol and nomenclature foundations)
• Other ISO/IEEE 11073 device specialization parts (11073-104xx)

Keywords: ISO/IEEE 11073, medication monitor, device interoperability, personal health devices, telehealth, plug-and-play, device communication, medication adherence.