DRAFT FAQ page

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General information

PIONEER is a secure research database containing data from acute health care services, those accessed for unplanned or emergency care. The database is one of seven Health Data Research UK (HDR UK) Hubs.

 

The PIONEER Hub will pool and link data from across healthcare providers, meaning healthcare professionals and researchers can look for recurring patterns, helping to develop new ways of predicting or diagnosing illness, and identify ways to improve clinical care.

 

See About Us to learn more about PIONEER.

Health records are not currently linked across different healthcare organisations. This means acute care providers rarely share health data about an acute care health event, even if a patient visited a number of healthcare providers for the same problem (such as pharmacy, GP, called 111 and then visited a hospital).  This can have a negative impact on the care for that person, and also prevents health data from being used to make vital improvements to acute health care services.  Improvement is needed.

Each year the NHS provides more than 300 million acute care appointments costing more than £17 billion pounds, bringing a significant incentive to improve this part of the NHS. Acute care has also seen less innovation – with fewer new treatments, devices or pathways, than other areas – because of a lack of sharing of health data.  PIONEER aims to change this.

PIONEER’s purpose is to use health data to improve health care and health care choices for people of all ages when they fall suddenly unwell or seek unplanned medical advice and healthcare. 

The large linked database has the potential to improve both outcomes and experiences for patients through research. This might be through earlier diagnosis of health problems, better understanding of treatment responses, designing better tools to diagnose illness or monitor patients, or designing devices which people can use themselves to monitor their own health.  The data can also be used to help prevent unnecessary trips to hospital by carrying out more tests and delivering more care in patients’ own homes.

Health data, such as test results, images, treatments prescribed, is routinely collected as part of an individuals care. It is collected to improve that individuals care and can also be used for other reasons, or “secondary purposes” such as research to find out more about disease or improve how the hospital delivers its services. For more information on health data and its uses see For Patients.

Using health data for research helps us to better understand diseases and conditions – their causes, prevalence and symptoms – and it can provide new ways of treating them or spotting them earlier.   There are lots of ways that health data science has improved our knowledge of health and care and has helped solve challenging health problems.

Here are just a few examples:

      • Diagnosing rare disease: whole genome sequencing has pinpointed the underlying genetic changes responsible for conditions in many patients through the 100,000 genome project
      • Studying the effects of immunisation: a comprehensive research study using health data proved that the MMR vaccine is not associated with autism. This evidence validated a public health policy that has saved a significant number of lives
      • Assessing the safety of medical interventions: use of comprehensive databases has shown that transfusions of blood from people who go onto develop cancer do not increase the risk of cancers in the blood recipients

When data from many patients is linked up across healthcare providers and pooled, healthcare professionals and researchers can look for recurring patterns in the data, helping to develop new ways of predicting or diagnosing illness, and identify ways to improve clinical care.

These improvements include:

      • Understanding which treatment options work best for patients and which patients are likely to benefit from different treatment options
      • Working out how to spot more quickly patients whose condition is deteriorating
      • Diagnosing illness earlier
      • Using bedside tests (called “point of care” tests) to diagnose illness without bringing someone into hospital
      • Developing devices which help people monitor their own health
      • Building better healthcare pathways that can be adapted to suit the individual

PIONEER will only share de-identified health data if using that data will lead to improvements in health and health care.  

If researchers have access to large health datasets, which include a broad range of people from many different backgrounds, it is more likely that they will find something that can help the NHS, you, your family, your community or someone else who gets sick and needs hospital care.  Emerging insights from researchers will be shared with clinical teams across the UK as quickly as possible, helping them to continuously improve care for their patients. These insights will help improve acute care for all patients, while making the most of precious and limited hospital resources.

Any project that PIONEER supports through the sharing of de-identified health data has to clearly provide benefit to NHS patients and the UK population.

The NHS can sometimes struggle to provide acute care for all the people who need help for unplanned health events (such as infections, falls or flare ups of disease).  This is especially true in winter and was highlighted very clearly during the first wave of COVID-19 in the UK. 

Data held by PIONEER will be used by healthcare professionals and researchers to treat patients more effectively when they are suddenly unwell.  This might include new treatments, new devices to diagnose or monitor illness, new ways to prevent illness and improvements to healthcare service delivery.

The individual health data from patients seeking acute health care advice will be de-identified, so that you cannot tell who the patient is.  All de-identified data from health care services working with PIONEER will be collected together, checked to ensure it a is correct and stored within a secure research database controlled by University Hospitals Birmingham NHS Foundation Trust. 

Healthcare professionals and researchers will be able to apply to access a specific part of the stored health data to answer questions about acute health problems, or to help design, test or improve healthcare devices, processes or treatments.  Only de-identified data will be shared and only those data fields which are needed to answer a particular question or project will be accessible. 

Patients and the public are at the heart of all PIONEER processes and patient members will sit on all senior decision-making committees and review how the data is used. All data requests will be reviewed by a group of patients and members of the public, called the Data Trust Committee, who will ensure all requests for data are in the public’s best interest. The Committee has to approve the data request before any data is shared.  All data requests will be reviewed against the “Five Safes” which are recognised principles to ensure data sharing only happens if the project, people, data and results are considered safe, are highly unlikely to lead to patient identification, and is in the best interests of the public. 

To begin with, data will be linked between four NHS hospitals (Queen Elizabeth Hospital Birmingham plus Heartlands, Good Hope and Solihull hospitals) and the West Midlands Ambulance Service. We expect other healthcare providers to join PIONEER as we move forward, so that the data included represents the whole region, and eventually all of the UK.

      • University Hospitals Birmingham NHS Foundation Trust (UHB), which will host the data and ensure compliance with all the required standards to process and store sensitive) health data. UHB has a digitally-mature and comprehensive electronic medical record system, built in-house, and has a long track record of safely storing health data from other hospitals. The UHB data team will be linking data from multiple healthcare providers for PIONEER.
      • The University of Birmingham
      • The West Midlands Ambulance Service
      • The University of Warwick
      • Insignia Medical Systems

PIONEER is a Health Research Authority (HRA) approved research database, approved by the HRA (reference 279353) and by the East Midlands- Derby Research Ethics Committee (reference 20/EM/0158).  The linkage of data has been approved by the Confidentiality Advisory Group (Reference: 20/CAG/0084).    UHB is the Data Controller for PIONEER and its privacy policy can be found here (https://www.uhb.nhs.uk/privacy-notice

PIONEER will be carefully managed with clear governance and accountability.  All processes have been approved by the Health Research Authority (HRA) and PIONEER will report all data access requests to the East Midlands-Derby Regional Ethics Committee that approves PIONEER on an annual basis. 

Data access will be under license and will meet the “Five Safes” criteria. 

A data licence is a legal contract which sets out how data can be used, by who, for what purpose and for how long.  Each PIONEER data request that the Data Trust Committee approve, will be bound by a specific data licence agreement.  The data license will only be granted if the Five Safes can be met and restricts the use of the data to the specific purpose for which it was requested.  

The PIONEER leadership team is responsible for how the project is managed and runs.  To ensure there is transparency about how data has been used, PIONEER will publish lay summaries for all data projects, followed by results once the data has been used.   Patient and public involvement will be a key part of PIONEER, with patient and public members helping make decisions about how the data is used.  

No, not specifically.

The NHS holds a huge amount of health data to provide the best healthcare for you.  This is the primary purpose for holding your sensitive health data. 

However, sharing this information responsibly and connecting these large data sets has great potential to improve health care. Using data for research and to improve health services in general is called “secondary use”. It can help speed up diagnosis, research new treatments, plan better NHS services and monitor the safety of drugs.  

Unless you choose to ‘Opt out’, your anonymised health data (de-identified, so you cannot be recognised) can be used by researchers from hospitals, academia and industry, without you specifically agreeing to your de-identified data being used.

The rules have recently changed due to the coronavirus pandemic. At the moment, all confidential patient information can be used and shared appropriately and lawfully for purposes related to the coronavirus response.

Find out more about Opting Out.

Yes, but we will only share de-identified data and decisions will be made following the principles of the “Five Safes”. Data will not be shared with any external organisation (including NHS, academic or industry) unless approved by the Data Trust Committee. This way, all decisions will be reviewed by patients and public members, and only those considered to be in the best interests of patients and the public will be provided with licensed data access.

The decision to support data access by commercial organisations was agreed following discussion with members of the public and patients.  

To permit data access by industry, technology and commercial bodies, the PIONEER protocol was approved by the Health Research Authority (the ethics regulator for health research).

Some commercial parties (such as Microsoft and ENSONO) have donated time and expertise to build PIONEER’s world-class digital research platform, meeting the most stringent governance and cyber security regulations.  These companies will not be permitted to access the data on the platform.

The “Five Safes” criteria are:

      1. Safe projects – is the requested use of the data appropriate?
      2. Safe people – can the researchers be trusted to use the data appropriately?
      3. Safe data – is there a risk that a person could be identified from the data and how can this be minimised?
      4. Safe setting – is the data stored in a safe manner which limits the possibility for unauthorised use?
      5. Safe outputs – could the results of the analysis cause any individual to be identified and how can this be minimised?

The PIONEER research database has ethical approvals to last for at least five years (July 2020 – July 2025).

The UK has some of the richest health data in the world, making it possible to make national-scale improvements to health and care.  Combined with unique research expertise, outstanding talent in the NHS and universities, and a vibrant life sciences industry, the UK has an opportunity to use data at scale to drive innovation, grow the UK industry base, and improve public health.

The NHS is recognised as one of the richest sources of health data internationally because it includes the whole population, from birth to death, across primary and secondary care.  Using health data from NHS electronic medical records for research has provided many benefits for NHS patients and the wider population.  

To increase the use of health data and to provide structure and transparency about health data use, Health Data Research UK (HDR-UK) was formed.  PIONEER is one of seven research Hubs set up by HDR UK. Find out more about HDR-UK.

Information on data

Detailed routinely collected data, updated at least weekly, from the electronic health record systems of participating healthcare providers.

This includes but is not restricted to:

      • Reasons for requesting unplanned medical assistance
      • Previous medical conditions, operations or procedures
      • Medications and allergies
      • All vital signs (such as heart rate, breathing rate, blood pressure, temperature)
      • All laboratory tests (e.g. blood, sputum or urine tests)
      • All imaging reports and copies of de-identified images (such as chest x-rays but not photographs of a person’s face)
      • Complications of illness and new diagnoses (such as heart attacks, strokes, fractures)
      • Severity of illness (for example, were they admitted to intensive care, was breathing or other support needed.
      • Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) status (i.e. whether a patient has decided that they do not want to be resuscitated if they can no longer breathe on their own).
      • Patient transfers within the hospital (e.g. between the Accident & Emergency department, wards and the Intensive Care Unit)
      • Final outcomes: Discharge including where they have been discharged to (their own home, a new social care setting etc.), adverse events, death.
      • What further outpatient care was organised (referrals to clinics, specialist services (such as physiotherapy) or further tests)

No. All of the data has been through a process called ‘pseudonymisation’.  Here, information that can identify people, such as a patient’s NHS number, name, date of birth or address have been removed.

Only pseudonymised data is added to the database. Even within the database, the data is still regarded as sensitive and can only be accessed for specific uses, by specific individuals, for a specific time period.  These pre-set criteria for data use are written into the data access license.   

The PIONEER research database includes de-identified/ pseudonymised data from patients who were seen by an acute care provider from 1st January 2000 and will include data from patients until the project closes (2025 at the earliest).

In general, although the health data comes from individual patients, it is held and processed by the individual NHS hospitals or healthcare providers who have looked after them. In technical terms, these NHS organisations act as the ‘Data Controller’ and are responsible for how that data is stored and used. Once pseudonymised data is added to the PIONEER database, UHB becomes Data Controller and is responsible for how PIONEER data is processed and used. 

If you have been a patient at one of PIONEER’s contributing healthcare organisations since 1st January 2000 it is possible that your data is being used within PIONEER to increase our understanding of acute healthcare medical and surgical conditions and improve treatment choices in the NHS. Your data may have answered, or may help to answer, questions that could improve patient care.   Each healthcare centre or organisation that is contributing data to PIONEER has a privacy notice which explains how data is used and you can contact your local healthcare provider to read this.

Unfortunately, we will not be able to tell you what questions your data has helped answer or solve, but you can find out more about the research projects supported by data from the PIONEER Hub and read about the research findings.

If you wish to remove your data from PIONEER, please contact us or contact the Patient Advice and Liaison Service (PALS) team at UHB, where you can register your request to opt out of PIONEER and will receive confirmation once this has occurred.  This will not affect the medical care you receive in anyway.

See Opting Out for more information.

PIONEER takes data security and privacy very seriously.  There are agreed national and international standards for processes to de-identify data.  This includes pseudonymisation, where a private and secure link remains between your data and your identity, which allows the data to be added to if a person has another hospital admission or healthcare contact. The researchers who are permitted access to your data in line with the ‘Five Safes’ criteria do not have or know that link (only the NHS Trust has this).  This also includes anonymised data, where no such link exists and there is no connection between your identity and the health data.

There are also set procedures to ensure that potentially identifiable data is protected.  For example, a postcode is used in some disease risk scores (such as the cardiovascular risk score called QRISK) and to estimate socioeconomic status, but PIONEER will never provide a researcher with a full postcode.  Instead PIONEER would (in these examples) either perform the QRISK score for the researcher and give them the QRISK score without the postcode or calculate the socioeconomic status score and pass the score to them, without the postcode.  That way, identifiable information is protected.

The PIONEER database will hold health data without obtaining explicit written consent from each individual.

The rationale for not seeking informed consent is that we wish to:

      1. Include as many people as possible. We need to include all patients who have had an unplanned, emergency contact to understand how services can be improved for everyone.
      2. Include a population that is fully representative of the patient population.
      3. Include data from patients who have died. We wish to learn from acute care situations where people have died in order to try and improve treatments and outcomes for other people.
      4. Include people who may not have capacity to consent so that more vulnerable adults also have the potential to benefit from innovation. Delirium (or acute confusion) is common in older people admitted acutely to hospital.

The scale of this data and the inclusion of data from people who have died prevent the gaining of informed consent for data use, as would be the usual standard. No additional data to that collected as part of standard of care is requested and all data will be accessed to fulfil the research request in a format where patient identification is extremely unlikely by the researcher.

As this is an important consideration, the use of data without explicit consent was specifically discussed with more than 300 patients to specifically test if the majority of the public would support data use in this way.  Find out more information about this patient questionnaire and the other patient and public engagement and involvement work we do in For Patients.

If you wish to remove your health data from PIONEER, you can do so. Find out more about Opting Out.

Data accessed and processed through PIONEER will be in line with existing, robust governance processes through current health data custodians, and current terms of access for the datasets.  These terms ensure that data accessed is proportionate, appropriate and done on a legitimate basis. This will only ever be done within the legal frameworks, strict parameters of the Codes of Practice and standards set out by the National Data Guardian and regulatory bodies including the Information Commissioner’s Office (ICO).

The data accessed will be de-identified, in line with Section 251 of the National Health Service Act, the Data Protection Act 1998 and GDPR (as well as the Public Benefit and Privacy Panel for Health in Scotland).   Researchers will be provided access to data through the existing processes that the Data Controller have in place and guided by the principles of the “Five Safes” to ensure data use is as safe as possible.

Under General Data Protection Regulations you have the right to ask an organisation whether or not they are using or storing your personal information. You can also ask them for copies of your personal information, verbally or in writing.  This is called the right of access and is commonly known as making a subject access request or SAR. This guide from the Information Commissioner explains how to make a subject access request.

Information on safety and security

UHB is the Data Controller for PIONEER data and is responsible for keeping it safe once it has been transferred to PIONEER.

Other health organisations contributing data to PIONEER will be the Data Controller for the data they hold within their own organisation.  Every member of staff who works for these organisations has a legal obligation to keep information about you confidential.  In the NHS, organisations maintain a duty of confidentiality by conducting annual training and awareness, ensuring access to personal data is limited to the appropriate staff, and information is only shared with organisations and individuals that have a legitimate and legal basis for access.

Once the data has been transferred to PIONEER, the overall responsibility for the safety and use of that transferred data lies with UHB who will control licenses for data access.  Every member of staff who works for UHB within PIONEER has a legal obligation to keep information about you confidential. 

Research data is held in a Trusted Research Environment or Safe Haven.  These are highly secure places that can only be accessed by members of staff who have been permitted access.  The aim is to enable maximum security, through multiple layers, and to minimise the risk of anyone’s data being misused. The PIONEER safe haven stores all data securely in a Microsoft Azure cloud platform, controlled by UHB.

The anonymised data needed to answer a specific research question is encrypted and only accessible by a limited number of researchers who are working on that particular project and have been granted permission by UHB as the Data Controller. Access to the data is only granted for officially-approved research purposes and is automatically audited and logged. All researchers who are involved in the studies have completed NHS Digital security awareness training and information governance training.

PIONEER has an access request process in place to ensure data access is in the public good and has the potential to bring benefits to NHS patients. The Data Trust Committee helps with decisions about data access.  This Committee, made up of public members: sees what requests are made to access the data, by whom; reviews which data fields have been included in the request; and helps decide which requests should be supported. UHB, as Data Controller for PIONEER, has final approval of what data can be shared, and oversees the legal contractual process to ensure this happens safely.  PIONEER will always put patient privacy, safety and benefit first and we have multiple safeguards in place to ensure this happens.  See the PIONEER protocol or how we operate.

No.  Data access will be licensed.  This means that researchers can only use the data for the purpose on the license, and not any other project.  It also means that data cannot be shared.  Only the data required to answer the research question is accessed.  Data does not leave this area and the area is closed after an agreed period of time or when the research question is answered (whichever is sooner).  The area does not contain any health data not directly related to the research question, and it is selective and sufficient; enough to answer the question but no more.

The organisations responsible for managing the data (the ‘data custodians’) already have tried and tested data protection plans in place to respond to threats to data security, including significant data breaches or near misses. These plans are regularly reviewed by the NHS and other organisations involved as part of their commitment to cybersecurity, and their legal duty under the Data Protection Act and General Data Protection Regulations to protect people’s data.

If ever there is a security breach, or a risk of a security breach, these plans will come into place and will likely involve reporting the incident to the Information Commissioners Office.

Information on patient involvement and ethics

Yes.  PIONEER was approved by the HRA (reference 279353), by the East Midlands – Derby Research Ethics Committee (reference 20/EM/0158) and by the Confidentiality Advisory Group (Reference 20/CAG/0084).

The PIONEER team recognises that some health data is very sensitive and that difficult questions may be asked of the data.  These might include sensitive diagnoses (for example, whether patients with a certain type of illness need different treatments when suddenly unwell) or about certain characteristics which might be important (for example, whether people of different ethnicities have a greater susceptibility to acute flare ups of illness).  Also, some diseases are very rare and by studying the acute care health contacts of people with rare diseases, this might increase the potential for a patient to be identified. 

To understand and consider these ethical challenges in PIONEER processes, each data request is discussed with public and patient members (our independent Data Trust Committee).  The Committee sees all data requests, including who has made them and what data access is asked for, and decides if data access is in the public interest.  PIONEER also has expert advisor information governance and ethics. 

Our work is transparent and we will publish lay summaries of both the requests for data access and the research findings.  Our protocol explains how data requests are considered and the role of the Data Trust Committee and is available for public review.

PIONEER processes have been defined in a protocol approved by an independent ethics committee and the Health Research Authority (HRA). This includes meeting all legal requirements when operating a health data research database. PIONEER will report to the Ethics committee and HRA, including what requests for data access have been made, on an annual basis. For more information, please see “On what legal basis will the data be accessed?” question.

Patients have been involved from the outset through workshops and surveys. They have helped define the processes for data access, what data should be included, whether de-identified could be accessible to commercial partners, and whether explicit consent should be sought (Get involved) for further information). Over 300 members of the public including more than 40 young people aged 1-17, took part in this process.

Our patient representatives and Data Trust Committee are involved to ensure that health data is used ethically and responsibly for the direct benefit of UK patients and the public, and to ensure the views of people who may be contributing health data to PIONEER are represented in our decision making.

The PIONEER team want to continue the conversation about health data use, to understand more about what different people think about health data use for research, innovation, and NHS improvements.  To learn more, visit our get involved page.

The use of health data is an important national conversation, and we would like to hear your views.  We’re committed to findings ways to encourage patients and the public to contribute to this conversation. Find out how you can get involved. 

PIONEER also has a rolling programme of events to what we are doing with the wider public.  Read our blogs, case studies and latest news stories.

If you have any questions about how we run and what we are doing, email us at pioneer@contacts.bham.ac.uk.

Information on research impact

The central aim of PIONEER is to use health data to improve patient care.   This might be through changing treatment pathways for patients, diagnosing disease early, designing new therapies, making it easier to select the right drug for the right patient or designing new devices to help people better manage their own health.

To ensure the scientific findings from PIONEER improve patient care for as many people as possible, we support open access publication.  This means placing the results of the data analysis in journals which anyone can access.  We also work with our patient and public members, HDR-UK and our healthcare and university partners to share scientific findings as widely as possible.  PIONEER will publish plain English summaries of the analysis which come from the dataset.

Yes.  Acute care is an international challenge, with many countries struggling to provide the acute care needed for their population.  It is important that we work as a global community to help each other. 

However, even though we will be sharing the knowledge gained from PIONEER with many countries across the world, your personal data will never leave the UK.  Instead we will share aggregated data such as the average age of people admitted to hospital, average length of stay in hospital, or most useful treatments.  This is how all data is reported in published papers and summaries, so that individual identity is protected.