Part of Applicability of DCB 0129 and DCB 0160
Terms and definitions
A number of terms are used throughout this guidance. The definition of the terms are provided below and supersede any other definition that may be used in any other standard or guidance. Where a term is taken from another source, that source is referenced.
Defined terms are presented between apostrophes throughout this report.
| Term | Definition | Reference |
|---|---|---|
| Clinical risk management |
Systematic application of management policies, procedures and practices to the tasks of analysing, evaluating and controlling clinical risk. |
DCB 0129 / DCB 0160 |
| Data flow | Communication of information relating to a patient or service used for the purposes of their care management. | This guidance |
| Digital product | A manufactured digital artefact, product or service that is used for health or social care purposes. This could include a 'health IT system', 'data flow', 'information standard' or 'medical device'. | This guidance |
| Deployment organisation | Organisation within which a 'Digital product' is deployed or used for a health or social care purpose. |
This guidance, adapted from DCB 0129 / DCB 0160 |
| Health IT infrastructure | Combined set of IT assets and health software for developing, maintaining, and using IT services and supporting healthcare. | ISO 81001-1:2021 |
Health IT system |
Product used to provide electronic information for health or social care purposes. The product may be hardware, software or a combination. | DCB 0129 / DCB 0160 |
| Implemented | Built into, part of, (for example, the 'Health IT system' or 'Medical device') | This guidance |
| Information standard | A document containing standards that relate to the processing of information. |
NHS Digital |
| Integrated | Connected with (the 'IT network infrastructure'). | This guidance |
| Intended use | Use of a product, process or service in accordance with the specifications, instructions and information provided by the 'Manufacturer' to customers. | DCB 0129 / DCB 0160 |
| Manufacturer | Person or organisation with responsibility for the design, manufacture, packaging or labelling of a 'Digital product', assembling a system, or adapting a 'Digital product' before it is placed on the market and/or put into service, regardless of whether these operations are carried out by that person or on that person's behalf by a third party. | This guidance, adapted from DCB 0129 / DCB 0160 |
| Medical device |
An instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which— (i) diagnosis, prevention, monitoring, treatment or alleviation of disease,..... Note: This is a short excerpt from the Medical Devices Regulations 2002. |
UK Medical Devices Regulations 2002 |
| Patient | A person who is the recipient of health or social care. | DCB 0129 / DCB 0160 |
| Publicly funded |
Any of the development, delivery and/or deployment of a 'Digital product' is undertaken by or on behalf of the following (as described in the Health and Social Care Act 2012, Section 250 (6)): (c) any public body which exercises functions in connection with the provision of health services or of adult social care in England; (d) any person (other than a public body) who provides health services, or adult social care in England, pursuant to arrangements made with a public body exercising functions in connection with the provision of such services or care |
This document, adapted from Health and Social Care Act 2012, Section 250 |
| Risk management | Systematic application of management policies, procedures and practices to the tasks of analysing, evaluating and controlling risk. |
DCB 0129 / DCB 0160 |
| Service user | A person who uses or is affected by the services of professionals registered with the Health and Care Professions Council (HCPC). | HCPC |
Last edited: 27 May 2022 9:51 am