Caldecott 3: Review of Data Security, Consent and Opt-Outs

‘Research is an essential part of improving the safety and quality of care: research facilitates the development of innovative new medicines, treatments and services. The National Research Ethics Service provides an ethical review of all health research involving patients in England. Researchers have worked hard to gain the trust of research participants: 2.2 million patients have agreed to take part in medical cohort studies, and the Review heard that this valuable contribution should not be undermined.’

The latest review of how the NHS manages your personal confidential data was released yesterday.

Unofficially known as ‘Caldecott 3’, the review led by Dame Fiona Caldicott aims to give staff working with your health records a much clearer indication of what they can and cannot do with them and is a rigorous examination of the complex issues surrounding the use of patient data in the UK.

From Foreward by Dame Fiona Caldecott:

‘In 2013, I led the Information Governance Review and we recommended an additional ‘Caldicott principle’ setting out that the duty to share information can be as important as the duty to protect patient confidentiality. I agreed to undertake this third Review for two reasons. Firstly, there has been little positive change in the use of data across health and social care since the 2013 Review and this has been frustrating to see. Secondly, because I believe we have a very significant opportunity now to improve the use of data in people’s interests, and ensure transparency for the public about when their data will be used and when they can opt out of such usage…’

For the review Dame Fiona was not specifically asked to look at care.data, the much maligned data sharing project frequently targeted by certain elements of the UK press, however in light of Dame Fiona’s recommendations NHS England has at the same time taken the decision to close the care.data programme.

In the review Dame Fiona makes a clear case for better use of data in the NHS and of the various potential benefits and risks associated with it, as well as clearly indicating that significant work will need to be undertaken to implement its recommendations.

Key to this is consent and the mechanisms behind the sharing of information. It has been recommended that where patient confidential information is to be shared there can be an opt-out model, but trust must underpin this.

‘Most people do not feel the need to know what is happening with their data, and people want to be able to trust the system and know that everything is okay.’

Ignite Data is in full support of all the recommendations made in the review as it will continue to lay solid foundations for biopharma to benefit patients, the NHS and UK Plc by running more and better studies using electronic data in the UK.

‘Our focus groups found that participants were generally supportive of data being used to run the health and social care system and for research.’