Standards on Health Informatics and Associated Medical Data Techniques

European standards, CEN standards, International standards, ISO standards, Health informatics, Genomic informatics, Patient health, Health records, Virtual human body, human model, Digital Health, Human scan data, AI-enabled


Technical committee



Related standards or drafts


It is now close to 30 years since the concept of Medical or Health informatics started to initiate its activities in ISO and later in CEN. Since then, parallel technology digital applications have been mushrooming to give hope to patients, make the work faster and enable more accurate diagnoses.

Health Informatics, an emerging discipline that amalgamates information technology with health care, is directed towards optimizing the acquisition, storage, retrieval, and use of information in health and biomedical science. Here, the role of International Organization for Standardization (ISO) standards and European Standards (EN) is influential in ensuring interoperability and safety.

ISO Standards globally, and European Standards within Europe, support the deployment of health informatics by promoting interoperability, performance safety, data protection, and harmonized compliance in health informatics deployment. These quality-centric and safety-guided standards enable a trusted, efficient, and universally operable health informatics system.

ISO, an independent, non-governmental international organization, develops standards to ensure the quality, safety, and efficiency of products, services, and systems. ISO has developed a plethora of standards for health informatics, such as ISO standards dealing with Electronic Health Record Communication, or standards outlining requirements for an Electronic Health Record architecture. These standards enable global comparability, ensuring the universal applicability of health informatics systems and services. They drive interoperability, essential in a globally connected health environment where devices and systems need to communicate and understand each other.

On parallel lines, European Standards (EN) also serve a similar purpose. These standards guarantee performance, quality, and safety, harmonizing divergent national standards. This harmonization propels a Single Market, making products and services developed in one part of the European Union usable and acceptable across the rest of the bloc. Simultaneously, Europe's General Data Protection Regulation (GDPR) places a heavy emphasis on data privacy and security.

In this page you will find a compendium of what is going on in the world of informatics and associated techniques, such as human body modelling and data and virtual human body, AI-enabled of medical devices, or application of machine learning to medical devices, or identification of medicinal products.

Click below on the different indexes to find associated International and European standards on different health informatics subtopics.