Hälso- och sjukvårdsinformatik

ISO 13940:2015 defines a system of concepts for different aspects of the provision of healthcare. The core business in healthcare is the interaction between subjects of care and healthcare professionals. Such interactions occur in healthcare/clinical processes and are the justification for the process approach of ISO 13940:2015. To be able to represent both clinical content and clinical context, ISO 13940:2015 is related to a generic healthcare/clinical process model as well as comprehensive concept definitions and concept models for the clinical, management and resource aspects of healthcare services. In practice ISO 13940:2015 covers the concept definitions needed whenever structured information in healthcare is specified as a requirement. The definitions are intended to refer to the conceptual level only and not to details of implementation. ISO 13940:2015 will cover all levels of specifications in the development of logical reference models within the information viewpoint as a common basis for semantic interoperability on international, national or local levels, information systems, and information for specified types of clinical processes.

The standard specifies interoperability requirements for personal health decision support (PHDS) based on the actors participating in PHDS, including service providers, data providers, and clients. The specifics of ‘how’ PHDS services are developed or implemented is not considered to be within the scope.

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.