Life science sector welcomes new guidance on NHS medical data sharing

Two concurrent reviews from national data guardian Dame Fiona Caldicott, and the Care Quality Commission, outline recommendations for improvements in the way medical data is shared and stored in the UK – a move which has been welcomed across the life science sector.

Many stakeholders say that the new recommendations represent a leap forward in the movement towards better exploitation of health data.

The pharma sector in particular will stand to benefit from well-managed data sharing.

If the public are to support their data being used for research we must address any concerns over security and be clear about who can access this data, when and why.  Sir Robert Lechler, president of the academy of medical sciences

Dr Virginia Acha, executive director of research, medical and innovation, The Association of the British Pharmaceutical Industry (ABPI), said:

“The sharing of patient health records under strong governance and safeguarding procedures to protect patient confidentiality has significant benefit to patient care and the healthcare system.

“It allows the ongoing research in the development of innovative and effective medicines from major chronic disease areas, such as cancer, cardiovascular, neurodegenerative, and respiratory, to rare disease areas, such as Huntingdon’s disease or cystic fibrosis.

“The work of the Caldicott Review takes us forward in advancing this agenda, moving health and care data from being an aspiration of some experts to becoming a realised and trusted resource for all.”

Sir Robert Lechler, president of the academy of medical sciences said: “With appropriate access to patient data researchers can seek to understand the causes of disease, to investigate the safety and effectiveness of drugs, treatments and interventions, and to improve health care services.

“If the public are to support their data being used for research we must address any concerns over security and be clear about who can access this data, when and why.”

Mental health research also stands to benefit from the actions proposed in the review.

Sir Simon Wessely, president of the Royal College of Psychiatrists, said: “There is sometimes a view that there is particular sensitivity surrounding mental health data, which can lead to even greater reluctance to share information relating to mental health care and has been cited as an obstacle to data-sharing. We do not support this view. 

“Mental health data is no more or less sensitive than any other medical information and it should be treated equally with physical health data.

“To do otherwise risks both reinforcing the continuing stigma surrounding mental illness and further disadvantaging our patients by restricting the appropriate sharing of data.”

Care.data abandoned

In response to the publication of the reviews, life sciences minister George Freeman announced in a Department of Health statement that care.data, the UK’s original plan for sharing medical data with relevant stakeholders, and holding it in a single database, would be scrapped.

Data-sharing as proposed by care.data was disastrously incompetent – both ethically and technically. Professor Sheila Bird, visiting professor, Strathclyde University

The project attracted much negativity during its existence, with critics arguing that it kept the public in the dark about how their data might be used.

Freeman said: “In light of Dame Fiona’s recommendations, NHS England has taken the decision to close the care.data programme.

“However, the government and the health and care system remain absolutely committed to realising the benefits of sharing information, as an essential part of improving outcomes for patients.

“Therefore this work will now be taken forward by the National Information Board, in close collaboration with the primary care community, in order to retain public confidence and to drive better care for patients.”

The decision to abandon the care.data plan in favour of a more carefully managed approach is a welcome one, according to Professor Sheila Bird, visiting professor, Strathclyde University’s Department of Mathematics and Statistics: “Data-sharing as proposed by care.data was disastrously incompetent – both ethically and technically.

“Professionals rebelled and prevailed in outcasting care.data, thereby ensuring that future proposals will not succeed unless both technically proficient and in the public interest.

“Just as research scientists have to seek approval for their data-linkage protocols and analytic methods, the same should apply to submissions by government departments; and, as for randomised controlled trials, the presumption should be that linkage protocols are registered and open.”

Digital vs. paper records

In a letter to health secretary Jeremy Hunt, David Behan, chief executive, CQC said: “The use of technology for recording and storing patient information away from paper-based records is growing.

“This is solving many data security issues but, if left unimproved, increases the risk of more serious, large-scale data losses.”

The impact on NHS staff

On the matter of healthcare providers, Behan said their findings, which were based on 60 hospitals, GP surgeries and dental practices, showed that GPs and social care professionals want a simple explanation of what they should and should not be doing with patient data.

A key factor in past data breaches, Behan said, was “people primarily

motivated to get their job done and often working with ineffective processes and technology”.

To this end, the review stresses that out-dated computer hardware and software must no longer be supported, and should be replaced as a matter of urgency.

For hospital and surgery IT staff, the recommendations include a tool to identify vulnerabilities such as dormant accounts, default passwords and multiple logins.

Personal preference

Ms Caldicott’s review also outlines an eight-point opt-out model for patients not wishing to have their data shared.

Crucially, the model states that patients should only need to opt-out once, with their choice being respected across the entire health and social care system.

At the same time, it aims to stress the significant gains that can be made from data sharing, both in terms of the individual’s personal care, and research and innovation in the sector.

Renate Samson chief executive of privacy campaign group Big Brother Watch said: “The recommendation that a long needed consent and opt out model for personal confidential health care data be established is hugely welcome.

“If adopted, it will give choice back to the patient, so they can actively control the flow of their health data, and have the right to protect it without the threat of a loss of healthcare provision or fear of discrimination.

“These proposals acknowledge that data sharing must be the choice of the individual and that a one size fits all model is simply unworkable.”

Remaining anonymous

Behan, in his letter to Hunt, says that in the majority of situations where data may be put to use, personal confidential data is not required – the emphasis, he said, should be on gathering high quality, linked, anonymous data.