ISO 29585:2023

The focus of ISO/TR 22221:2006 is clinical databases or other computational services, hereafter referred to as a clinical data warehouse (CDW), which maintain or access clinical data for secondary use purposes. The goal is to define principles and practices in the creation, use, maintenance and protection of a CDW, including meeting ethical and data protection requirements and recommendations for policies for information governance and security. A distinction is made between a CDW and an operational data repository part of a health information system: the latter may have some functionalities for secondary use of data, including furnishing statistics for regular reporting, but without the overall analytical capacity of a CDW. ISO/TR 22221:2006 complements and references standards for electronic health records (EHR), such as ISO/TS 18308, and contemporary security standards in development. ISO/TR 22221:2006 addresses the secondary use of EHR and other health-related and organizational data from analytical and population perspectives, including quality assurance, epidemiology and data mining. Such data, in physical or logical format, have increasing use for health services, public health and technology evaluation, knowledge discovery and education. ISO/TR 22221:2006 describes the principles and practices for a CDW, in particular its creation and use, security considerations, and methodological and technological aspects that are relevant to the effectiveness of a clinical data warehouse. Security issues are extended with respect to the EHR in a population-based application, affecting the care recipient, the caregiver, the responsible organizations and third parties who have defined access. ISO/TR 22221:2006 is not intended to be prescriptive either from a methodological or a technological perspective, but rather to provide a coherent, inclusive description of principles and practices that could facilitate the formulation of CDW policies and governance practices locally or nationally.

ISO/TS 29585:2010 has three sections, 1) general considerations of design and deployment, 2) data aggregation and data modelling and 3) architecture and technology, and is intended to provide an overall set of guidelines for clinical data warehouse deployment supported by useful descriptions concerning different data aggregation and modelling approaches as well as particular aspects of information architecture that contribute to successful deployment. The first section is of particular interest to healthcare decision-makers, including information technology managers, of requirements and procedures that support successful clinical data warehouse deployment. The second section supports the understanding, choice, instigation and evaluation of methods that ensure reliable selection and aggregation of primary data for adequate compilation and presentation to support decisions – this section is of particular interest to statisticians, epidemiologists, healthcare evaluation specialists and others. Section three is of particular interest to informaticians concerned with efficient architectures, data mining methods, dynamic data querying and visualization for clinical data warehouses.