All questions are shown as received by the Trust.
For the purposes of this FOI, Health IT Systems are defined as “Product used to provide electronic information for health or social care purposes. The product may be hardware, software or a combination.”
Please note that this definition encompasses any hardware or software product used within the organisation. It does not have to be used for a clinical purpose (i.e., it may be clerical) and applies to both non-medical and medical devices (the latter as defined by UKMDR2002).
This definition is taken from the following sources:
● DCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems – NHS England Digital
● DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems – NHS England Digital
Requested Information:
1. The total number of Health IT systems currently in use by the organisation.
2. The number of Health IT systems currently in use by the Trust that have BOTH DCB0129 (from the manufacturer) AND DCB0160 (from the deploying organisation) Clinical Safety Case Reports.
3. The number of Health IT systems currently in use by the Trust that have a valid DCB0129 Clinical Safety Case Report from the manufacturer ONLY (i.e. have a DCB0129 report but NOT a DCB0160 report).
4. The number of Health IT systems currently in use by the Trust that have a valid DCB0160 Clinical Safety Case Report from the deploying organisation ONLY (i.e. have a DCB0160 report but NOT a DCB0129 report from the manufacturer).
5. The total Whole Time Equivalent (WTE) of Clinical Safety Officers who are currently actively working on DCB0129/DCB0160 implementation within the Trust.