Use of Personal Data

Why we are able to use personal information without consent?

Within the PRiSMM study, researchers are looking to establish a new data platform containing the health data of all women in England aged 12 and over at the time of their first pregnancy record with a recorded pregnancy and babies born as a result of those pregnancies. They will use this platform to monitor safety and to see if changes being made to how maternity services provided locally and across the country, can reduce the number of women who become sick or unwell during or shortly after pregnancy. To carry out this work effectively, researchers need to see the full picture of how maternity care is being delivered for all women who have a pregnancy recorded and all babies born as a result of those pregnancies. Seeking consent to access health data from every pregnant woman in England would not be possible and the law therefore allows researchers in circumstances where the research is deemed to be in the public interest, to apply to use patient data without consent.

The research team has applied to the Confidentiality Advisory Group (CAG), an independent body which provides expert advice on the use of confidential patient information. The key purpose of the CAG is to protect and promote the interests of patients and the public, while at the same time facilitating appropriate use of confidential patient information for purposes beyond direct patient care. We have provided CAG with the background information about the PRiSMM programme and an explanation as to why we need to access confidential patient information, and the safeguards and security measures we will put in place to protect this information. If the CAG is satisfied with the information provided, they can advise the Health Research Authority (HRA) to give Section 251 support which will provide the legal means for the data controllers (the NHS Trusts) to provide researchers with access to confidential patient information without consent.

Will all my health data be included in this research?

No. Some health data is considered to be particularly sensitive such as information about abortions or sexual health. We will not be asking to access to this information. Additionally, we will not have access to any identifiable data (such as name, date of birth, address) held by the social care or child protection services. Identifiable information about individuals included in the PRiSMM programme will not be shared with any government agencies or departments.

What happens to personal information that flows into the PRiSMM Data Platform?

During the pilot phase of the project, health and care data for all women receiving care at any of the eight champion sites and whose electronic patient record indicates a pregnancy will flow securely from the NHS Trust to the Thames Valley and Surrey Secure Data Environment (TVS SDE). Health and care records for any babies born as a result of those pregnancies, will also flow securely to the TVS SDE. At this stage the data will include patient identifiers to enable the data to be linked with data received from other sources. The TVS SDE is an NHS organisation and only NHS staff will have access to any information that might identify an individual.

NHS staff working within the TVS SDE will transfer the data to a dedicated PRiSMM Data processing environment. For the purposes of safety monitoring the TVS SDE staff will then remove all personal identifiers such as name, date of birth and NHS number to 'de-identify' the data before transferring all the de-identified data to the PRiSMM workspace in the Trusted Research Environment (TRE) where it can be accessed by PRiSMM team researchers and analysed.

Data to be used to evaluate the introduction and implementation of the MCB will be treated differently. As this work is classified as 'research' TVS SDE staff will first remove the data of anyone who has opted out of sharing their data via the National Data Opt-Out process or via the PRiSMM-specific opt-out process (see below for how to do this) and only once this has been done will they remove all personal identifiers to 'de-identify' the data.

At this point the de-identified data for research will then be transferred to the PRiSMM workspace in the Trusted Research Environment (TRE) to be accessed by PRiSMM team researchers and analysed. You may find it useful to watch the video below which explains about Secure and Trusted Research Environments.

How does this affect my data protection rights?

You can find out from the Information Commissioner's Office (ICO) website about your data protection rights.

If you wish to opt out of sharing your health data nationally or for this specific research study, your ability to exercise your data protection rights will not be affected as your health data will not be included in the research to evaluate the MCB. However, for the safety monitoring it will not be possible to opt out and the de-identified health data for all women aged 12 and over with a recorded pregnancy will be included in the analysis. Your data protection rights will therefore be limited because the data will be de-identified and it will not be possible to find out which data belongs to you.

Will my health data be shared with other organisations?

No. All data used by the researchers will be de-identified and researchers will not know who you are or where you live. The PRiSMM researchers will only use the de-identified health data collected for the specific purposes that they have received approval for. They cannot and will not share this information with any other organisation such as social care, probation, safeguarding, adoption services, industry or commercial companies.

What happens to the data collected as part of the interviews & focus groups?

Interviews and focus group sessions will be recorded and transcribed using secure or encrypted software to provide the researchers with a record of what was said. Once the transcripts have been checked all recordings will be deleted. During the process of transcription, names and any information that could identify a participant will be removed or changed to maintain anonymity. Transcripts will then be stored securely on servers located at the University of Oxford and only researchers directly involved in this research will be able to access them.

How do I opt-out from my health data being used by the PRiSMM team for research purposes?

If you do not want your data to be used specifically for our research study, you can withdraw at any time by contacting:

Name

Thames Valley & Surrey Secure Date Environment Team

Address

TVS SDE
Executive Offices
John Radcliffe Hospital
Oxford
OX3 9DU

Email

tvssde@ouh.nhs.uk

Tel

01865 227300

Please indicate that you wish to opt out of the PRiSMM study. You will be asked for your name, date of birth and NHS number so that your choice can be registered.

How do I opt-out from my hospital data being used for all research and planning purposes?

If you have previously completed the National Data Opt-Out, which enables patients to opt out from the use of their data in this way, we will automatically exclude your data from the research aspects of the study. If you haven't already completed the National Data Opt-Out, but now wish to do so, you can find out how do this on the NHS Digital opt-out website.

Information is available in 11 different languages and as an audio version, a British Sign Language video and an Easy read leaflet from the NHS - Your Data Matters website.