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Fair processing statement for a rare disease study

The Data Protection Act 1998 requires organisations to process personal data fairly and lawfully. The methods by which these processes are governed and explained to patients are known as ‘fair processing’.

University College London Hospitals (UCLH) is working on a project with Wilmington Healthcare to use England Hospital Episode Statistics (HES) data to identify episodes which have been coded with combinations of ICD-10 codes that suggest clinical features compatible with a diagnosis of Niemann-Pick Type C (NPC)[i]. HES data from NHS Digital will be used to identify individual patients and to contact the physicians looking after them in order to suggest the potential diagnosis of NPC and propose suitable diagnostic testing.

This project is funded by Actelion Pharmaceuticals Ltd. University College London Hospitals (UCLH) will act as the data controller, with Wilmington Healthcare providing analytical support as the Data Processor.

What data will be shared?

As part of this project, the Local Patient Identifier (from the HES dataset) will be supplied to UCLH from NHS Digital (with Wilmington Healthcare providing analytical support). Although this data is identifiable neither Wilmington Healthcare nor UCLH will be able to identify individual patients. Wilmington Healthcare will be passing the local patient ID to the clinician (identified and validated using their General Medical Council number) that has the legitimate relationship with the patient, and they will be able to access their data locally. Therefore, patient identification is only taking place by the treating clinician, at the NHS trust responsible for the patient’s care.


The legal basis for the flow of identifiable data between NHS Digital, UCLH, Wilmington Healthcare and the NHS trust for the treating clinician is the National Health Service Act 2006 – section 251 [ii]– ‘Control of patient information’ and the Health and Social Care Act 2012 section 261(7).


How will data be shared?

  • A letter will be sent to the treating clinician explaining the potential diagnosis of NPC. They will be told how they can use the supplied Local Patient Identifier number to identify the patient and the diagnostic assay available, should they wish to pursue the diagnosis
  • The treating clinician will be asked to let UCLH know the number of patients contacted and the NHS laboratory doing the diagnostic test will let UCLH know how many samples were sent as a result of this project and what percentage tested positive (covered by the Section 251 approval
  • A reply slip is made available for this purpose and only the patient study id and no other patient-identifiable data is requested on the reply slip
  • The treating clinician will be contacted after the initial letter has been sent to see if they have contacted their patients


Processing Activities for the project

  • Step One: Wilmington Healthcare will use existing HES (as provided under the monthly agreement – DARS-NIC-16016). The aim is to identify approximately 400 patients with the clinician taking final judgement.   The sample size was specified to be 3,500 to enable a preliminary look through using a combination of codes, but those included will be restricted to approximately 400 people identified as at risk of potentially suffering from Niemann-Pick Type C. Wilmington Healthcare will look at episodes coded with combinations of ICD-10 codes which suggest clinical features compatible with a diagnosis of Niemann-Pick Type C. Additionally the cohort will have appeared in HES at least ten times with the relevant ICD-10 codes and will have been treated by the same treating physician no less than eight times.
  • Step Two: Wilmington Healthcare to send NHS Digital a list of the cohort Encrypted HES IDs and associated Epikeys for the cohort
  • Step Three: NHS Digital to link the cohort to the HES database
  • Step Four: NHS Digital to extract the relevant HES fields for the cohort
  • Step Five: NHS Digital to provide extract to UCLH.  The Local Patient Identifier will be separated from the HES extract and sent to UCLH in a separate file.
  • Step Six: Wilmington Healthcare to oversee the loading of the data extract (at UCLH). This will be downloaded to an encrypted lap top by the Principal Investigator at UCLH
  • Step Seven: UCLH commence data analysis

The above steps are the only data processing steps required for this project.

Data security and permissions

UCLH is acting as the data controller for the duration of this project. At the conclusion of the project, the data will be securely destroyed in line with NHS Digital’s Destruction and Disposal of Sensitive Data Good Practice Guidelines (which can be found here)


Any patient wishing to opt out of data sharing/linkage as part of this project can do so by writing to Wilmington Healthcare. You will need to supply your Local Patient Identifier in order for the opt-out request to be processed.

For further information please contact or call 01268 495600.


[i] Niemann-Pick C is a rare neuro-visceral lipid storage disorder which causes progressive neurological disease. The best recognised form of the disease starts in childhood and usually results in death in the late second or third decade from aspiration pneumonia. However, there are also many patients who have ‘attenuated’ forms of the disease which present later in life with some atypical clinical features and slow progression.

[ii] Section 251 of the NHS Act 2006 allows the common law duty of confidentiality to be set aside in specific circumstances where anonymised information is not sufficient and where patient consent is not practicable.

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