Privacy and Data Security in SPIDeRR:

a Guide for UK Citizens.

 

Health data about people with musculoskeletal problems is a precious resource for research, to improve care in the future:

A third of people experience significant musculoskeletal problems during their lifetime, but it can take many weeks or months for them to get a diagnosis and start the right treatment. In order to develop new digital tools that help such people – and their doctors – to access the most useful healthcare services for them at the earliest possible stage, data scientists need to work with “real-world” data from the health records of thousands of people. In SPIDeRR, these real-world data will come from electronic health records (EHRs) of people in both primary and secondary care (family doctors and hospitals) across multiple countries in the EU, including the United Kingdom (UK). Data scientists do not need to access personal details of all these people, such as their names, dates of birth and postal addresses – they are not interested in this information and it will be removed before the data is made available to the researchers. But they will have access to detailed information on measurements, symptoms, blood results and diagnoses for these people. All these data will help the scientists develop computer algorithms and artificial intelligence tools that are of use to doctors when applied to individuals presenting with musculoskeletal symptoms for the first time – to help prioritise management strategies and, where necessary, referral pathways. To enable this in the UK, we have worked hard to ensure the security of the data about people’s health that will contribute to digital tool development. Our approach has been subject to careful scrutiny by an independent Research Ethics Committee and a Confidentiality Advisory Group, both administered at a national level under the UK government’s Health Research Authority.

What follows is an explanation of the steps we have taken (i) to ensure the security of data obtained from primary and secondary care in SPIDeRR, and (ii) to be certain that the privacy of the people described by the data is respected. The SPIDeRR partners dealing with data from the UK are Newcastle University and the Academic Health Sciences Network for the Northeast and North Cumbria (NENC) – the information that follows only applies to UK citizens who live, or attend a GP or hospital, within this region of the UK (specifically, Newcastle upon Tyne Hospitals or GP practices in the vicinity); no data will be extracted from other UK sources during the lifetime of the SPIDeRR project.

Extracting EHR data about people with musculoskeletal complaints in hospital (secondary care).

A search will be conducted to identify EHRs relating to individuals presenting with musculoskeletal complaints – whether attending the rheumatology department or the Newcastle upon Tyne Hospitals more generally. Once the relevant health records have been found, they will be “de-identified at source,” using three step process. First, data items which could directly identify an individual will be removed from the record in their entirety; this would include individual’s name and address etc. Second, other data items which could lead to identification will be transformed into a non-identifiable format; for example replacing date of birth with age, and postcode with a social deprivation measure based on address location. Finally, an industry standard tool will be used to create a project specific patient number allowing complete removal of patient identifiers from the dataset. The “de-identified” data will then be transferred using a secure file transfer service to a “secure data environment” (SDE) housed by the lead academic institution for SPIDeRR, namely Leiden University Medical Centre (LUMC), in the Netherlands. An SDE is a “protected” space that is very secure and only accessible by registered individuals: de-identified data from UK EHRs can only be transferred into the SDE by responsible individuals at Newcastle upon Tyne Hospitals, and it cannot be removed from the SDE after that. With permission, named researchers across the SPIDeRR consortium can work on the de-identified data in the SDE, but they cannot remove it to another location; the only way the data can be removed from the SDE once transferred into it is for it to be deleted. In relation to the SPIDeRR project, a legally binding data sharing agreement (DSA) has been reviewed and signed by the Information Governance Team at Newcastle upon Tyne Hospitals (with oversight from Newcastle University as the primary research partner) as well as LUMC partners. This confirms that data handling will be compliant with European Union law (General Data Protection Regulation, GDPR), which continues to apply in the UK after “Brexit.”

Extracting EHR data about people with musculoskeletal complaints in GP practices (primary care).

We will access information about people with musculoskeletal complaints attending their GP practices. We will prioritise GP practices involved in the care of the largest possible number of people with musculoskeletal complaints for whom we have also collected EHRs at Newcastle upon Tyne Hospitals – because this will ultimately afford researchers with the richest data with which to develop digital tools. We have had to adopt a different approach to extracting data in Primary Care, because GP practices are not usually resourced to be able to spend time doing the data extraction, de-identification and transfer (to the SDE). Therefore, we are working with a NHS contractor called the NHS North of England Care System support service (NECS), who have the expertise to be able to provide this service for our GP partners. An individual from NECS will be responsible to de-identification of EHRs from primary care (including those linked to secondary care records) prior to their transfer into the SDE. Each individual participating GP practice will sign a data sharing agreement with LUMC, under the same conditions as those in place for secondary care data.

 

 

Frequently asked questions.