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The sharing of patient data for research and clinical purposes has been a highly controversial issue, and attempts to introduce the care.data scheme in 2014 were met with concern about patient privacy and resistance from aspects of the patient and medical community. Following on from that debate, Dame Fiona Caldicott was commissioned to produce a report on patient data that could make recommendations about how to proceed with such a scheme in the future.
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, published today, 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.”
Prof Sir Robert Lechler, President of the Academy of Medical Sciences, said:
“We welcome the publication of this review and the attention it focuses on improving data security for health information and developing a new model of consent through discussion with the public.
“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. The recommendations announced today will make steps towards achieving this.
“We need to engage in conversations with the public, patients and healthcare professionals if we want to ensure a trusted system for storing and sharing health information is in place. For this reason we welcome the call for a wider dialogue that will give all sectors of society a chance to shape and inform the way health data is used.”
Dr Jeremy Farrar, Director of the Wellcome Trust, said:
“We will only unlock the immense value of patient data if we have open and honest discussions about how and why data can be used for care and research, what’s allowed and not allowed, and how personal information is safeguarded. We welcome Dame Fiona’s call for a full conversation with the public and are very pleased to announce that we are setting up a new independent taskforce to explore the most effective ways to have discussions about uses of data.”
Ms Aisling Burnand, Chief Executive of AMRC, said:
“Dame Fiona’s and the CQC’s recommendations set out the building blocks for fostering public trust in the handling and care of their information and we welcome these. Recommendations alone cannot build trust, the actions that follow are critical.
“The Secretary of State for Health must now hold a full and comprehensive consultation on the review, and then set out a clear plan to implement a new consent approach and ensure data security standards are met in the NHS and care organisations. Giving people choice about how their information is shared was a manifesto commitment. A timetable of action is needed to deliver on that commitment.
“People need to feel that they can trust the system to handle their information with care and competence, and respect their wishes. If the public do not trust the system, they will be unwilling to share health information for medical research and this will seriously hinder progress on new treatments and cures of diseases such as cancer, dementia, rare conditions and many more.”
Prof Jeremy Pearson, Associate Medical Director at the British Heart Foundation, said:
“The use of patient data is crucial for delivering good care, running the NHS efficiently and conducting research which saves and improves lives. The BHF believes that we must ensure that researchers can access the data which they need to carry out their work while also protecting the privacy of patients. We welcome Dame Fiona Caldicott’s Review and will further analyse her recommendations in detail before responding to the consultation.”
Prof Sir Simon Wessely, President of the Royal College of Psychiatrists, said:
“The College welcomes the recommended new data security standards for health and social care and the proposal to develop a new consent/opt-out model. Patients are best served if decisions about the NHS and the services it provides are informed by the best available information.
“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.
“Clearly, our patients, as all patients, need appropriate information and support to provide informed consent for their data to be shared. Good training, delivered annually and face to face to specific groups of staff, supported by clear and concise policy and procedures, is thus essential for information-sharing. There is much focus on the sharing and use of information, but we must remember that this sharing and use is only helpful if the patient record also demonstrates good qualitative information.”
Prof Sheila Bird, visiting professor, Strathclyde University’s Department of Mathematics and Statistics, said:
“The implications from this report are key to England’s recovery from the arrogant fiasco of care.data. Patient data have the potential for making public health discoveries by answering novel questions from existing data, including serial event-dates and polypharmacy and adverse events in the elderly.
“Originally under the proposed care.data plans, personal identifying information was collected simultaneously with medical-in-confidence data, when pseudonymisation should have been substituted for personal identifying information before medical-in-confidence data were abstracted from GP-records.
“This abstracted data would have included demographic and socio-economic details, serial and co-temporaneous prescribing information, together with event-dates for GP attendances and the reasons for attendance. By linkage to cause-specific hospitalizations, the cost-effectiveness and adverse-event-rates of poly-prescribing in the elderly can be explored empirically with regional differences and clustering within GP-practice taken into account. A quiver of questions about community-based management of mental health problems can be posed and answered. Cost-efficient randomized comparison can be proposed of how to manage specific conditions for patients for whom there is currently a substantial diversity of GP-selected interventions. And much more besides.
“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 randomized controlled trials, the presumption should be that linkage protocols are registered and open.
“For an example of how other countries handle medical data, look to Scotland where trust in record-linkage has been safeguarded by robust practice: ethically and technologically. Moreover, Scotland – unlike England and Wales – properly records data on the dead. In Scotland, fact of death is registered within eight days of death having been ascertained whereas in England and Wales, for coroner-referred deaths, fact of death is not registered until the inquest-verdict determines cause of death. Prime Minister Cameron has twice refused the Royal Statistical Society’s call for legislation to end the late registration of deaths in England and Wales. Late registration seriously delays the discovery-potential from record-linkage studies such as those at the interface of public health, inequality and criminal justice.
“Discoveries are made when well-posed novel questions are answerable. Good questions make for research-excellence in record-linkage as in other fields of application.”
Sir John Chisholm, Executive Chairman of Genomics England, said:
“We welcome the publication of the National Data Guardian’s (NDG) review and Dame Fiona Caldicott’s recommendations. The digital revolution is underway in healthcare and the potential benefits of sharing our health data are enormous. Research using new technologies can greatly improve our understanding of health and disease, unlocking new treatments that could benefit each and every one of us in the future.
“However, we must be able to have absolute confidence in the way our data is looked after by the bodies responsible for it. Measures to increase understanding of how data is used along with the choice to opt out of data sharing, should an individual wish to do so, will help to ensure people are able to have an informed view and a say in how their data is used in future.”
Link to the report: https://www.gov.uk/government/publications/review-of-data-security-consent-and-opt-outs
Declared interests
Dr Virginia Acha: No conflicts of interest.
Prof Sir Robert Lechler: Robert Lechler is Vice-Principal (Health) and Executive Director of King’s Health Partners Academic Health Sciences Centre our recently accredited Academic Health Science Centre. Robert also heads a leadership giving fund, the Medical Circle, which enables alumni and friends of the College to support the School of Medicine across all the hospital sites at Guy’s, King’s and St Thomas’. He has had European Union Funding for part of his research programme for the last 12 years. This has included FP5, FP6 and FP7 consortia funding.
Dr Jeremy Farrar: No conflicts of interest.
Ms Aisling Burnand: No conflicts of interest.
Prof Sir Simon Wessely: No conflicts of interest.
Prof Jeremy Pearson: No conflicts of interest.
Prof Sheila Bird: For 25 years, mainly in Scotland but also in England & Wales, Sheila Bird has made discoveries from without-consent, properly-approved, powerful record-linkage studies – including at the interface of public health and criminal justice. She has been a critic of care.data, see article on Statslife. Sheila Bird leads for the Royal Statistical Society on the need for legislation in England & Wales to end the late registration of deaths. Late registration of fact-of-death handicaps record-linkage studies – by delaying them. She is a visiting scientist at the Farr/Usher Institute at Edinburgh University and formerly a programme leader at the MRC Biostatistics Unit in Cambridge.
Sir John Chisholm: None received.