4.1 NHSScotland has a legal and moral duty to protect an individual's confidentiality. Modern healthcare systems depend however, on information from current and former patients. The existence of an effective healthcare system is in the public interest and in the interest of anyone who needs treatment. If the healthcare community were unable to make use of information from patients, it would be impossible to plan and manage services, protect and improve health. Measures to check that patients receive the correct care would be unreliable and the ability to carry out research and develop new and better treatments would be severely curtailed. It is CSAGS' view that this would be against the public interest and also the interests of all of us who at one time or another need healthcare.
4.2 The consequence of this blend of different interests is that NHSScotland must make sure that patient identifying information is processed fairly and confidentiality is protected but that in return, it is fair and lawful to share information from patients provided that high standards of confidentiality are maintained and anonymised data are used wherever possible.
4.3 NHSScotland uses patient identifying information for the following purposes:
PATIENT CARE
4.3.1 Patients are often treated by a team of health professionals such as nurses, doctors and occupational therapists. They may also receive social care from a local authority or voluntary agency. Some may also receive spiritual care from a minister of religion. Each member of the care team will need to have some information about the patient, so as to be able to give the correct care. If information could not be shared in this way, it would be impossible to provide effective healthcare. Presently many records are maintained on paper. This makes it very difficult to restrict the access of different professionals to the information they need to know. Even so, NHSScotland already has codes of conduct in place to prohibit inappropriate access to an individual's health records. As electronic records become more widely used, NHSScotland will have the option of developing electronic measures to ensure that each member of staff only sees that part of an individual's record which is relevant to them. However, many argue that any health professional should have unrestricted access to a patient's entire record (at least for a particular episode of care) so as to be able to decide how best to care for an individual. We hope this issue will be discussed and resolved amongst health professionals and UK health departments with a view to issuing guidance.
OPERATIONAL MANAGEMENT
4.3.2 NHSScotland uses patient identifying information to identify the health needs of communities and to plan, provide and evaluate service provision. Examples of the way information might be used for operational management functions would be:
4.3.3 Often the information used for these tasks is in a form that does not enable individuals to be identified. Sometimes however, these kinds of activity require the use of information from which individuals could be identified.
COLLECTIONS OF DATA
4.3.4 A particular area of concern during our consultation was the use of collections of patient identifying information such as in registries. The use of information gathered together into registries has been well-established practice for many years. One of the earliest registers is the Domesday Book of 1086. Another example is the first national census, which was carried out following legislation in 1800. The term 'registers' often carries connotations of serious disease, legal responsibilities or vital events such as birth and death. Many registers presently in use go back several decades, sometimes several centuries. In modern times, we are now able to maintain databases or collections of data which reflect both the potential of computers and new ways of treating and caring for patients. Examples of recent registers are shown in the box below.
|
Type |
Use/example |
|
Preventive medicine |
Immunization/screening of specific populations |
|
Genetic Counselling |
To record families at high risk (in order to be able to know the likelihood of a genetic disorder) |
|
Specific Disease Registers |
Commonly used for follow-up, treatment call up, audit, research, assessing population health needs, epidemiology eg Blind Register, Cancer Register, Diabetic Register, SMR (Scottish Morbidity Record) |
|
Population Register |
Commonly used for administering health services and for research eg Community Health Index, National Health Service Central Register and for research |
|
Treatment Registers |
eg Thyroid Disease, Joint Replacement |
|
After Care Registers |
eg Children with Special Needs |
|
At Risk registers |
eg children; occupational hazards; medical hazards; elderly or chronic sick |
|
Skills and Resources Registers |
Used for administration and planning, eg blood donors |
|
Specific Information Registers |
eg congenital defects; ophthalmic; communicable diseases |
|
Prospective Audit and Research Studies |
eg The National Child Development Study - data gathered on defined set of individuals to study change and association |
4.3.5 Information is collected on people with similar characteristics so as to provide services for individuals as a group, to monitor that they are receiving the appropriate care, and to learn from that care so that services can make improvements for future patients. Generally speaking, it is in the individual's interest to be part of such a data collection, and it is in the public interest to ensure that healthcare professionals have a picture of the quality of care or state of health which people experience. However, the information will only be useful if kept accurate and this often requires the use of patient identifiable data.
4.3.6 Collections of data are no different from registers or databases, and are integral to management of individual patient care and the administration of services. Principles of good practice are also similar to those where other uses of information are involved. It is the wish of CSAGS to ensure that any such collections are made and managed with the full knowledge of the people involved and that best practice in holding and using the information is applied.
CLINICAL RESEARCH
4.3.7 Patient identifying information is used in trials of new treatments. It is established practice that participants are asked for explicit consent before they take part in clinical trials. The consent process will cover any use of patient identifying information.
EPIDEMIOLOGICAL RESEARCH
4.3.8 Epidemiological studies often involve thousands of patient records but tend not to involve direct contact between a patient and a clinician nor to use named data except to link items from different sources that are then anonymised. It is expected that wherever possible people will know about such studies and that their data are likely to be included. However, the practical difficulties in contacting large numbers of individuals can result in consent not always being sought before patient identifying information is processed.
4.3.9 Population-based research like this often uses large data sets (of the kind which NHSScotland collects) in order to monitor new or important diseases and to assess the effects of treatment or discover the underlying causes of disease. Examples of this are the links between smoking and cancer; between thalidomide and birth defects; or the association between leukemia in children and radiation. We depend on this kind of research in detecting new diseases and in monitoring the safety of new drugs and treatments, eg prescribing drugs to prevent thrombosis following major surgery, or for a vaccine against HIV. For most of these purposes complete data are important because opting out, even by small numbers of people, can bias the results and lead to wrong conclusions.
Feedback from the Consultation
4.4 Our consultation exercise has confirmed anecdotal evidence that large numbers of health professionals are extremely concerned that involving patients in decisions about the use of their information may cause practical difficulties. They fear that some patients will withhold their data or some clinicians will be reluctant to pass on information because of concern about a legal challenge. They also anticipate delays in consultations and disruption to clinics. They make the point that the cost and impact of complying with the law is difficult to quantify but believe it would be borne by anyone who suffers from ill health.
4.5 A widely debated example is cancer. Presently NHSScotland has some of the best information on cancer in the world. This is because Scotland has a cancer registry which collects information on the prevalence of various types of cancer, risk factors and the effectiveness of preventions and treatments. While the registry works within established privacy and ethical frameworks, it collects and links patient identifying information from a wide range of sources without explicit consent and often without patients' knowledge. Clinicians who care for those with cancer and cancer patient representatives have made a strong case that in future, the cancer register may be unable to function effectively, unless the law is changed to allow disease registers to continuing processing patient identifying information without consent.
4.6 An alternative view expressed by some health professionals and individuals who participated in the consultation exercise emphasised the overriding need to ensure privacy rights are protected. Their opinion was that the attitude of many clinicians towards patients requires a fundamental change to one where a dialogue between patient and clinician, both on the care to be provided, and any use of that patient's information, is the expected norm. They thought that NHSScotland has yet to implement fully the required change of culture to ensure that patients' rights on the uses of patient identifying information are properly recognised. They supported the idea that NHSScotland needs to ensure that its systems and procedures match the interests of patients and the public, not just those of the Service. This sentiment reflects the view that there is a broad need to change the culture of the Health Service and involve patients more in decisions about their care.
CONCLUSIONS
4.7 There is a need to weigh up individual rights and claims to confidentiality against the rights and claims of individuals and the whole community to better health and to protection against threats to ill health.
4.8 The use of information about patients is necessary for treatment and for the operational management of NHSScotland. When used for management purposes the information can often be provided in a form that does not enable individuals to be identified.
4.9 Epidemiological research often relies on information derived from very large numbers of patient records. Such research rarely involves direct contact with patients.
4.10 Health professionals already seek informed consent before enrolling patients in clinical trials. The consent process covers any use of patient identifying information.
4.11 The culture of patient centred care should extend to the use of patient identifying information.
4.12 There is scope to review many existing information flows to confirm their compliance with the law and good practice and that they are in the interests of patients and the public.
4.13 There are differing views on the relative importance of time taken to discuss uses of information compared with spending time on treating the patient. It is CSAGS' view that the law requires patients to be informed; the question is the level of detail that should be given and when should explicit consent be sought.
4.14 There is widespread concern amongst health professionals that complying with the law and other confidentiality requirements will inhibit their ability to provide the high quality data needed to improve standards of healthcare.