Use of pseudonymised (de-identified) patient data for the NIHR ARC D-Med Study

Our GP practice is participating in the D-Med Study (Research Ethics Committee ref: 21/EM/0163), a NIHR ARC project to determine a better care pathway for older frail people with type 2 diabetes. This is undertaken by a research team based at the Leicester Diabetes Centre, part of the University of Leicester. The data will be used with the aim to improve patient health care.

The legal basis for this research is ‘a task carried out in the public interest’ (Article 6 1(e) of UK GDPR) and Article 9(1)(j) ‘is necessary for scientific research purposes in accordance with Article 89(1)’.

Information from patient health records will be available for researchers as pseudonymised data. Data is pseudonymised at the point of extraction within the GP Practice. This means the data is de-identified in a way that minimises any risk of a patient being identified and will not be made available to the research team. The use of pseudonymised data does not need patient consent as it is used in the kind of research where an individual does not need to be identified.

The data extraction and pseudonymisation process is carried out by PRIMIS (primary care health informatics based at the University of Nottingham) on behalf of the research team. A data processing agreement is in place with the research team’s sponsor at University of Leicester to ensure safeguarding controls are in place to protect the confidentiality and security of information extracted.

Anyone who has opted-out (under the National Data Opt-Out service) from their data being used for planning and research purposes, will not be included in the D-Med Study and their data will not be processed. D-Med study researchers will keep pseudonymised data for 5years in line with the University of Leicester’s data policy.