How should we balance protecting our data and sharing it to improve patient care?

Posted on February 24, 2012 by


Yesterday the Department of Health announced that Fiona Caldicott will lead an independent review of the balance between protecting patient information and its sharing, to improve patient care. This will publish recommendations for government before the end of 2012. Patient data is a huge resource for medical research. As the largest health system in the world, the data resource the NHS can offer researchers is considerable and in the recent Life Sciences Strategy the government announced new measures to try and improve safe and secure access to data. So these recommendations are going to be crucial to shaping the system to both support valuable research  to improve healthcare and ensuring the public can have confidence in how the NHS is managing their data.


Dame Fiona Caldicott led a review of the security of patient information in 1997. This set up a system with individuals in every NHS and local authority who make decisions over sharing of identifiable information, balancing the public  interest of protecting confidential information with the public interest for sharing the information. These individuals are called “Caldicott Guardians“.

Patient data is a huge resource for health research – see this leaflet explaining how data is used at the moment.

But the system is very complicated and does not work perfectly, there are particular difficulties around getting an individuals consent to be approached if there is a research study relevant to them (meaning a researcher will need to look at their data to find out whether the study is relevant to them first), and enabling researchers to access identifiable data which they might need to do for example if they want to explore the incidence of disease in particular geographical areas or if they want to link information with different datasets. It’s important that a safe and secure system is developed that enables valuable research to go ahead while ensuring that the public can have confidence in how their data is managed by the NHS.

The Academy of Medical Sciences conducted a very detailed review of this a few years back – Personal data for public good: using health information in medical research.

And an independent review established by the Government and led by Mark Walport (Director, Wellcome Trust) and Richard Thomas (Information Commissioner) published a report in 2008 making recommendations on the use of patient data for medical research. To which the government responded in November 2008

And there is a really good summary of all the issues in the Academy of Medical Sciences recent review of the regulation and governance of health research – chapter 6 and includes some great case studies of research projects that have had difficulty getting off the ground in the current system.

In the Strategy for UK Life Sciences published in December last year, the government announced steps to develop a safe and secure system which opens up patient data for research and ensures patients are offered opportunities to be involved in research relevant to them are valuable. These include the creation of a Clinical Practice Research Datalink linking up datasets from GP and hospital care so that it is possible for  researchers to access data about a patients entire journey through the care system, and a planned consultation on the NHS constitution to explore whether  we should move to a system where anonymous data collected during a patients care in the NHS may be routinely used for research unless the patient has asked to opt out.

We’re expecting an Information Strategy to be published around April time which will include a section on the use of patient data for health research and may have more detail on the planned consultation.

What’s happening now?

Fiona Caldicott is now pulling together a working group of clinical, social care, research and other professionals, as well as patients and service users to decide a detailed scope and priorities for the review.

Is this important for medical research charities?

Patient data offers a considerable resource for research to develop new treatments and improve healthcare.

AMRC polling found that there is considerable public appetite for these opportunities to be made available:

  • 72% would like to be offered opportunities to be involved in trials of new medicines or treatments if they have a health condition that affects their day-to-day life.
  • 80% would like to consider allowing a researcher confidential access to their medical records.
  • 88% would be happy to be asked to talk to researchers about their family history or give a sample of their blood to be tested in a laboratory.

However the system doesn’t work perfectly and further work is needed to enable safe and secure access to data by researchers to ensure that patients can be offered relevant opportunities to be involved in research.

What next?

Once the working group is up and running we’ll get more detail of the scope of the review and how we can contribute. AMRC will be looking at how we can feed into the review, whether we can gather more helpful evidence and information from the charity sector – including the views of patients –  to feed in to the group’s discussions.

Posted in: Policy