Alison McCallum is Caldicott Guardian for NHS Lothian, the unified health board that provides services for around 867,800 people in Edinburgh and the Lothians. The Caldicott role is one of many that she has performed there since 2005 as the Director of Public Health and Public Policy. It is a small but important part of her workload, taking on average 30 hours a month to discharge, excluding committee meetings.
Alison is committed to research as integral to high quality prevention, treatment and care. She can cite evidence of the good that can be achieved by means of safe, ethical analysis of large linked data sets. She acknowledges that sometimes researchers and clinical staff see the application of Caldicott principles as just another process delaying their study. However, in her view, the role of Caldicott Guardian is to be an enabler. This includes allowing research to take place by making sure it is done in the right way.
An example of how patients benefited from this approach came from audit and research into the treatment of subarachnoid haemorrhage. It was important to study the records of all affected patients so that recommendations were not biased by inadvertently excluding those who were more seriously ill. The audit used information from GPs and hospital clinical records, brain scans, nationally collected healthcare data, cause of death certificates and residential data about whether or not people had moved away. She says: “It was an object lesson in learning from the experience of patients in the past to benefit the care of those in the future.”
Alison is particularly well placed to understand the differences in how the system works in Scotland and England. She was Caldicott Guardian in East and North Hertfordshire health authority while Director of Public Health there in the late 1990s.
She says: “There are no differences in the Caldicott principles that operate north and south of the border, but they have to be interpreted according to different legal and healthcare systems. In Scotland, patients agree to the secure use of their data when they register with a GP and they are reminded of how the NHS uses data to improve care when they make use of specialist services. In addition to the requirement to provide prevention and treatment, the NHS (Scotland) Act 1978 identifies research, education and training as health service functions. However, once data moves “beyond the physical or virtual bedside”, it must be de-identified at as early a stage as is practical without compromising care.
Alison approves around 500 Caldicott applications a year including those affecting NHS Lothian and others received in her role as the Chair of the multiagency data sharing partnership. The volume of applications has increased hugely as people have come to understand the potential of clinical data to improve the quality of patient care. She says her seniority and responsibility for the population as Director of Public Health gives her authority to take a balanced approach to risk by agreeing projects that a less experienced colleague might reject or approve without the appropriate safeguards. However, taking a risk is not a matter of bending the rules. Alison’s decisions are reviewed by a governance committee including a non-executive director, a member of the Area Clinical Forum and the Employee Director.