- This document notes that standards play a crucial role in the planning, design, implementation, operation and governance of the systems in this sector.
- It describes the panorama of technical standards, their importance and the benefits they provide.
- It contains the standards related to digital health as these pertain to today's context and the digital transformation of healthcare, endorsed by the standardization bodies ISO, IEC, CEN, CENELEC, and UNE.
Madrid, 5 December 2023 - The Spanish Association for Standardization, UNE, has prepared, in cooperation with the Spanish Society for Computing in Health (SEIS), the report "Standards for digital health", which describes the crucial role of standards in the digital transformation of the healthcare sector.
Specifically, standards are essential for the planning, design, implementation, operation and governance of the systems in this sector, helping them overcome challenges such as interoperability, cybersecurity and privacy. In addition, standards help healthcare to use new digital technologies for research, diagnosis and treatment.
The publication describes the panorama of technical standards, their importance and the benefits they provide. In the current context of the digital transformation of healthcare, this report was published to present and identify the standards related to digital health endorsed by the international standardization bodies ISO and IEC; the European bodies CEN and CENELEC; and the UNE in Spain.
In order to make the report easier to understand, it has been structured into the following areas of application: architecture; organization; clinical information models; infrastructure; health data; terminology and guidelines; communication with devices; electronic clinical history; computing in medicine and pharmacy management; protection and security of health data; patient safety; digital health services; accessibility and usability; as well as data and artificial intelligence.
Digital health standards play a key role in:
- Facilitating the interoperability of information and processes through the different domains of health and healthcare in general.
- Providing continuity of care between different treatment and organizational levels.
- Making precision medicine feasible in the National Health System through the generalized joint use of clinical and genomic information.
- Generating locatable, accessible, interoperable and reusable quality data sets (FAIR principles, Findable, Accessible, Interoperable, Reusable) for use in research and public health, which are important to improving the quality of care and efficiency of research.
- Allowing the creation of the National Health Data Area for mass processing and analysis, and establishing conditions and resources to generate and extract knowledge.
- Supporting the provision of efficient health services where, when and how they are needed.
- Ensuring patient safety and the security and protection of their data.
- Making cross-border health services and research possible.
- Developing the national and European market for digital health systems, making them more competitive.
Digital health standards are the result of international, European and national development work that has been carried out for several decades under the title of health information technology.
Since its creation over 30 years ago, the UNE Committee on Health Information and Communication Technologies (CTN-UNE 139) has drawn up 227 standards within the framework of international collaboration with the European Committee for Standardization (CEN) and the International Organization for Standardization (ISO). SEIS manages the secretariat of this committee, while actively promoting the dissemination and creation of a collaborative environment of ICT standardization for health through the Health Interoperability Forum.
CTN-UNE 139 has traditionally emphasized, and will continue to do so, the role of UNE standards, especially those related to international and European standards, to provide security, protection and competitiveness in the market to digital health information systems.
