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Surgical Devices and Implants Pilot Register: GDPR information
Why and how we process your Surgical Device and Implant data and your rights.
|How we use the information (processing activities)||Surgical Device and Implant information is administrative and clinical data, including details of specific medical devices implanted, revised, or removed for a patient, as well as other medical devices used in the treatment of the patient. The data supports improved patient safety through enabling surveillance of surgical devices and implants through linkage of the data and to support patient focused activities such as review or recall of specific devices. Initially the focus of data collection will be information relating to Class III and Class IIb implantable medical devices. The initial focus will be on surgical mesh used for pelvic floor surgery (pelvic organ prolapse and stress unrinary incontinence), prolapsed bladder, prolapsed uterus and prolapsed rectum. Other surgical devices and implants may be reported on a voluntary basis. NHS Digital collects the data and undertakes data quality and data linkage activity before making the data available to Medicines and Healthcare products Regulatory Agency (MHRA), and other interested parties who have a business need and appropriate legal basis. It also supports reporting of associated clinical data and data relating to pelvic floor surgery both involving the use of surgical mesh and alternative procedures not involving surgical mesh. This will be used to analyse and compare patient outcomes relating to the use of surgical devices and implants against alternative procedures not involving a surgical device or implant.|
|Does this contain sensitive (special category) data such as health information?||Yes|
|Who are recipients of this data?||
|Is data transferred outside the UK?||This data is not transferred out of the UK|
|How long the data is kept||20 Years minimum from death|
|Our lawful basis for holding this data||Legal obligation|
|How can you withdraw your consent?||
Consent is not the basis for processing.
|Is the data subject to decisions made solely by computers? (automated decision making)||No|
|Where does this data come from?||Clinical team providing patient care|
|The legal basis for collecting this data||
Health and Social Care under section 254
Further details can be found in the Surgical Devices and Implants Pilot Data Collection.