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Surgical Devices and Implants Pilot Register: GDPR information

Summary

Why and how we process your Surgical Device and Implant data and your rights.

Controller NHS Digital
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?

None

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
Your rights
  • Tick Be informed
  • Tick Get access to it
  • Tick Rectify or change it
  • Cross Erase or remove it
  • Tick Restrict or stop processing it
  • Cross Move, copy or transfer it
  • Cross Object to it being processed or used
  • Cross Know if a decision was made by a computer rather than a person
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
GDPR:
Article 6(1)(c) - Legal Obligation (General Powers),
Article 9(2)(g) - Substantial Public Interest
DPA 2018:
Schedule 1, Part 1, paragraph 2 - Health or social care purpose

Further details can be found in the Surgical Devices and Implants Pilot Data Collection.