ISO/IEC 30197-1 ED1 Internet of Things (IoT) - IoT for stress management, good health and well-being – Part 1: Framework
Draft under development
Draft under development
CEN/TC251 Health Informatics is a standards delivery organisation, meaning that it approves standards in Europe, but the standards do not have to be created in Europe. In fact, many of them come from the global health informatics committee ISO/TC215. For this reason, it is important to monitor and contribute to the standards prepared in ISO/TC215. This is what the purpose of this fellowship was about.
ISO/TC215 has around 10 working groups (WGs) and CEN/TC251 has two. I am the convener of the second one and I try to follow those ISO/TC215 WGs that operate within the scope of my WG in CEN/TC251. This is not always easy because the ISO/TC215 WG meetings take place at the same time. In ISO/TC215 I participate mainly in interoperability, information security, and health software development areas.
Artificial Intelligence (AI) is coming to healthcare, too. As I have AI experience through my doctoral studies and projects that followed, it has been natural for me to follow AI standardisation, too. The ISO/TC215 meeting in Toronto in October 2025 made it clear that the number of AI related work items is increasing in ISO/TC215. ISO/TC215 has a joint working group 3 (JWG3) with JTC1/SC42 Artificial Intelligence. The idea is that the ISO/TC215 AI work items are developed in this JWG3. Attendance in JWG3 is important also because I am a member of the CEN Strategic Advisory Group on AI in healthcare.
During the ISO/TC215 Toronto meetings in October 2025, SC42 held its meetings in Sydney, Australia. After the working day was over in Toronto, work began in Sydney in Toronto evening time. I participated in particularly the healthcare AI standards development JWG3 and SC42/WG4 Use Cases meetings virtually in Sydney. Attendance in JWG3 meetings was important to motivate the ISO/TC215 initiated standardisation projects to the SC42 leadership. Through my participation, the other parties became more aware of European values in AI standardisation.
This document specifies a set of representational primitives and semantic relations needed for an unambiguous representation of explicit time-related expressions in health informatics. This document does not introduce or force a specific ontology of time, nor does it force the use of a fixed representation scheme for such an ontology. Rather this document provides a set of principles for syntactic and semantic representation that allow the comparability of specific ontologies on time and the exchange of time-related information that is expressed explicitly. This document applies to both the representation of actual phenomena occurring in the real world (e.g. registrations in medical records) and to the description of concepts (e.g. medical knowledge bases). This document is applicable to a) developers of medical information systems where there might be a need for explicit time-related concepts for internal organization (e.g. temporal databases, temporal reasoning systems), b) information modellers or knowledge engineers building models for the systems mentioned in a), c) experts involved in the development of semantic standards on precise subdomains in health care where time-related information needs to be covered, (e.g. in the study of pathochronology, i.e. the discipline dealing with the time course of specific diseases), and d) developers of interchange formats for messages in which time-related information is embedded. This document is not intended to be used directly for — representing what is true in time, — reasoning about time, or — representation of metrological time.
This project developed an implementation guide constraining CDA Release 2. The implementation guide supports electronic submission of HAI data to the National Healthcare Safety Network. CDC provided NHSN developers, vocabulary experts and CDA experts to support this project.
The Electronic Nutrition Care Process Record System (ENCPRS) Functional Profile is based on the Electronic Health Record System Functional Model R2 (EHRS-FM). The intent is to develop a standard list of functions and criteria needed for full integration of both the Nutrition Care Process (NCP) and the representative terms from the Nutrition Care Process Terminology (NCPT). The NCP serves as a systematic approach to providing high quality nutrition care. This standardization will encourage the acquisition of EHR systems by nutrition health providers and promote information interoperability between nutrition and food systems and other areas of healthcare. These requirements have been mapped into this functional profile and identify those portions of the HL7 EHR-S Functional Model that apply to patient care in the Nutrition Care Process. Further, these requirements identify functionality toward facilitating ease of use for those involved in patient care using the NCP, thus providing EHR vendors with conformance criteria that are specific to regulated tasks within the NCP in the HL7 International formats.
Early Hearing Detection and Intervention (EHDI) programs exist world-wide to help identify children with hearing loss. Because newborn hearing loss is a neuro-developmental emergency, children with hearing loss need to be identified shortly after birth to help them achieve better communication outcomes. This implementation guide focuses on the transmission of the hearing screening data elements from the hearing screening device to a recipient of data, which may be an electronic health record (EHR) or a Public Health Information System.
Many seemingly healthy babies with Critical Congenital Heart Disease (CCHD) may suffer negative health outcomes if the birth defect is not identified shortly after birth. International efforts have precipitated both program and legislative initiatives to promote and/or mandate universal newborn screening for Critical Congenital Heart Disease using pulse oximetry devices. When pulse oximetry devices are able to exchange data with information systems, the use of standards helps with the seamless exchange of data and improve patient safety. This implementation guide focuses on the transmission of CCHD screening data from the device to the public health program, other potential recipients including providers and electronic health records.
The Privacy and Security Architecture Framework (PSAF) is the overarching package that contains four balloted specifications and an informative guide. The specific normative components include: 1) Trust Framework for Federated Authorization Conceptual Model, 2) Trust Framework for Federated Authorization Behavioral Model, 3) Provenance Domain Analysis Model and 4) Audit. The intent of these standards is to provide an integrated package of a set of standards to advance communication and interoperability among partners in a shared trust framework environment.
The scope of the standard is to define the message for exchanging information electronically between Regulators and Industry, and between sets of regulators. The message provides the ability to describe the contents of the regulatory exchange and all information needed to process the exchange between parties. This message is designed to be flexible enough to be used to support regulatory exchanges for any regulated product.
The Unique Device Identifier (UDI) Pattern provides the guidelines for exchanging UDI information associated with medical devices, initially implantable devices in patients. This document will not give implementation guidance for specific use cases and worfklows, but will set the overarching guidelines for all working groups that need to exchange the unique device identification on the fields and format intended for expressing UDI related data using V2, V3, and FHIR. The goal of the UDI Pattern is to enable semantic interoperability for recording UDI information on medical devices used on or implanted in patients regardless of the information exchange standard used to move the information across (e.g., HL7 Version 2.x, HL7 v3 messages or CDA, HL7 FHIR).
This HL7 Version 3 (V3) standard describes the processes whereby HL7 V3 artifact specifications may be refined, constrained and extended to support implementation designs, conformance profiles, and realm-specific standards.
The scope of this standard is a service-oriented medical device architecture and communication protocol specification for distributed system of Point-of-Care (PoC) medical devices and medical IT systems that need to exchange data or safely control networked PoC medical devices. It identifies the functional components, their communication relationships as well as the binding of the components and communication relationships to protocol specifications.