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GDPR and the NHS ‘opt out’: a chance to engage patients in research

Andrew McConaghie explores what GDPR and the less well-known NHS opt out mean for clinical research and real world evidence in the UK

nhs digital

Last Friday, 25 May was a milestone date for the future of global data-driven healthcare, and in particular for England’s NHS.

That’s because the day saw the introduction of new rules governing the use of personal data. The first is the European Union’s new comprehensive data protection and privacy regulation, the General Data Protection Regulation (GDPR).

Anyone with an email account will be more than aware of this event, as inboxes have been flooded with notifications from companies and organisations seeking consent from individuals to hold on to their data and maintain contact.

As the GDPR also encompasses the export and use personal data outside the EU, it is having a truly global impact, and is setting new standards in data handling in an age where data has become one of the most valuable commodities.

Its arrival comes in the wake of the scandal surrounding the ‘data scrapping’ of Facebook users by Cambridge Analytica - and the GDPR underscores the need for individuals to have greater control and clarity around who holds their data and for what purposes it is used.

While GPDR applies to all data, its safeguards and building up of personal control of data will be especially important in healthcare, where consent and trust in researchers using data is absolutely vital if a ‘big data’ and real world evidence (RWE) enabled healthcare is to become a reality.

Arriving on the very same day, the NHS’ own ‘National Opt-Out' has come in response to the GDPR, introducing this new clarity of consent specifically for the approximately 55 million patients registered with England’s health service.

Co-ordinated by NHS Digital, it allows people to opt out of their confidential patient information being used for research and planning. These researchers could include universities, hospitals, medical royal colleges or be pharmaceutical companies researching new treatments.

The hope is, of course, that most patients choose not to opt out, and allow their data to be used for research purposes. This is especially important for the NHS, as it holds what could be one of the world’s most complete population-level datasets anywhere in the world.

The UK government’s vision is that, with all the proper safeguards and patient consent in place, NHS data could prove to be a world-class engine for research, attracting greater R&D investment and ultimately benefitting NHS patients as well.

What it means for the pharma industry

So what do the GDPR and NHS opt-out mean for the UK research environment and the pharma industry?

Above all, they provide the means for patients to take control of their health data,and provide active consent for its use in research.

Naomi Boxall

Naomi Boxall (pictured), Principal - Epidemiologist at IQVIA and specialising in in real world evidence (RWE) comments: “By gaining consent from NHS patients to use their health data, the UK stands to enhance its place as a world leading data-rich research ecosystem. Increased global investment in clinical trials and real-world evidence studies would feed back directly into the economy and into NHS care.”

“GDPR and the NHS Patient Data Opt-Out is a real opportunity for the Life Sciences industry to build trust within the patient communities who allow their data to be used for research,” add Tim Sheppard, SVP of Northern Europe for IQVIA. “By implementing these new standards patients can be increasingly assured that they are in control of their data and that it will be handled responsibly.”

Tim adds: “As an industry we must continue to vigorously demonstrate the benefits to patients in terms of health outcomes of the research we conduct using their non-identified health care data.”

This strengthening of UK data protection must also address fears about data leaks of highly sensitive medical records, however.- the WannaCry ransomware cyber attack of May 2017 was a high profile example of the threat posed to NHS organisations.

That means the NHS must invest in IT systems to maintain confidentiality and security, and communicate clearly how these safeguards work in order to allay fears.

The patient voice in research

There is a clear need for the public and patients to take a more active interest in these questions of consent, and how their data is put to use. Consequently, patient advocacy groups, such as UseMYData, are now championing the appropriate use of patient data for research.

Chris Carrigan

UseMyData’s expert advisor and patient advocate Chris Carrigan (pictured) comments: “The opt out gives choice to people in a much more open way. I think this is a very positive step in the right direction – but it’s just the start of a long conversation with patients and the public, not just about the benefits of using their data but also the risks.”

Having this balanced conversation about benefits and risks means that the explanation of those benefits needs to be as compelling and clear as possible – NHS patients will need to be convinced that researchers using their data will be important and impactful – not just for them but all patients today and in the future.

Naomi Boxall adds: “Our responsibility then, as researchers, is to provide access to published research which illustrates why patient participation is so important.

“If we provide full, accurate and detailed information to patients when seeking their consent, we will improve trust between doctors and patients and can improve each patients’ understanding of the value of their data – to themselves and to society as a whole.”

This will hopefully minimise the numbers who will choose to opt out, which remains a possibility if they lose faith in a system where their data is used in ways they hadn’t anticipated or had explained to them.

There is good reason to believe 25 May will be seen as a turning point for the UK’s research environment.

The UK pharmaceutical sector invests £11.5 million per day in research and development, and while the UK constitutes under 3% of the global pharmaceutical market, it typically attracts more than 5% of research and development spending. This could be further boosted in a new environment which recognises the changes as a ‘win win’ for research and for patients.

“The life science sector is now shifting its focus towards the individual patient's needs, rather than “illness or drug orientated care,” says Naomi Boxall. “This shift fundamentally makes patients an active participant in their own care; allowing them to influence clinical trial design, treatments received, and moreover, the outcomes perceived. In so doing, the patient’s input becomes invaluable in medical research, as the value of that research is clear to all stakeholders.”

In other words, informed consent underpins not only patient centricity but the future of research.

Boxall concludes: “A fully informed and engaged patient should be the goal of everyone involved in healthcare.”

31st May 2018

31st May 2018


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