Patient data rules could undermine vital NHS improvement projects

More than 1.5 million patients have already opted out of sharing their clinical information

Patients opting out of their data being shared for research could damage more than 40 national audits relied on to improve care (Getty/iStock)

Crucial insights into how care and safety can be improved across the NHS are at risk of being undermined by new rules on patient data and confidentiality coming into force next month.

The rules, which were delayed from March, could prevent hospitals sharing patient data with any research project or study which has not been granted a special exemption – and could impact key areas like cancer, diabetes, stroke, mental health and maternity safety.

The changes could affect the 40 national clinical audits of NHS services carried out in England every year which reveal how patients are treated for specific conditions and where there may be wider systemic problems.

More than 1.5 million patients had opted out of sharing their data by June this year. Without access to all patient data, analyses by researchers could be weaker and impact the conclusions reached.

While the overall national opt-out rate is 2.6 per cent, there is wide variation between areas and among GPs with some practices having zero opt-outs, while others have almost 90 per cent of patients opting out.

Officials in the Department of Health and Social Care are urgently considering whether to extend the deadline further.

One project that could be affected is a national study into maternal and baby deaths run by the University of Oxford. MBRRACE-UK (Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries) is a national programme examining deaths in maternity units to help highlight areas for improvement.

Their work has revealed that heart disease is the biggest killer of pregnant women. It also found black and minority ethnic women were five times more likely to die in childbirth than white women.

Clea Harmer, chief executive of the stillbirth and neonatal death charity Sands, said she was very worried about the impact on learning for the wider NHS.

She said: “If this goes ahead a trust will not be able to report details about a mother’s death or that of her baby to the MBRRACE team.

“It is just mind-boggling when you think about what this could mean. The rate of opt-out varies hugely from 0.3 per cent of patients in some areas to 10 per cent in Oldham for example, it could mean some communities being far more affected than others.”

She said the result could be inaccurate conclusions because not all data would be shared with researchers.

The national clinical audits are funded by NHS England and run by the Healthcare Quality Improvement Partnership. HQIP declined to answer questions on the data opt-out but NHS England said the rules should not stand in the way of improvement work.

A spokesperson said: “We agree that the data rules the NHS has to follow should enable clinical audits to continue unaffected.”

The national data opt-out was first launched in 2018 and patients are able to opt out of their medical records being shared for research and limiting their use to individual care and treatment.

Information can still be shared in an emergency where there is a wider public interest or exemption granted for research to be carried out.

The deadline for hospitals and other organisations to comply with policy is the end of September. It was extended from March while organisations dealt with the coronavirus crisis.

A Department of Health and Social Care spokesperson said: “We are committed to enabling the health and care sector to continue to prioritise its response to Covid-19 and are actively considering whether the compliance date for the national data opt-out should be extended. We will provide clear direction as soon as possible.”