Published: 07/10/2004, Volume II4, No. 5926 Page 20 21
The guardian of NHS patient data has taken a lot of flak in its first three years - notably over its powers to release confidential information without consent - but the arguments for allowing disclosure have been made just as forcefully
The patient information advisory group (PIAG) was established three years ago under section 60 of the Health and Social Care Act 2001.
It is regarded as a significant and sometimes controversial body by some groups in the NHS and the research community, but is totally unknown to many more. It grew out of the recommendations of the Alder Hey inquiry into organ retention and follows work by the Caldicott committee into personally identifiable NHS information.
PIAG is a statutory body that advises the secretary of state. It is concerned with who should have access to patient-identifiable data for secondary use and in what circumstances. Section 60 was introduced to allow access for medical purposes where it was impracticable for various reasons to obtain informed consent.
Cases that have come to PIAG have included applications from researchers working on longitudinal studies going back many years, where it is impossible to contact patients, as well as applications from big national databases, such as cancer registries, where important work needs to continue.
PIAG can allow access to patient information where consent has not been given, but it uses this power sparingly and is firmly committed to the 'consent culture', to anonymisation and to patient empowerment. As the then health minister Hazel Blears said when launching PIAG: 'The group will play a crucial role in ensuring that patient-centred consent practice continues. . .
those organisations which obtain section 60 support to use information about patients without their consent will, in future, be expected to demonstrate that they are developing mechanisms to either obtain informed consent of the patient involved or to develop ways of anonymising data.'
PIAG's 'strapline' is: 'Ask or Anonymise'. This describes, in simple terms, the response we normally give to applicants for exemption under section 60.
The creation of PIAG gave rise to various concerns, some of which remain today. There was a worry that the government might use the powers of the health secretary under section 60 to get hold of confidential data on individual patients which legislation would otherwise have debarred him from accessing.
Some critics saw this as one more example of a Big Brother culture pervading Whitehall. GPs feared they would be fined for refusing to hand over confidential information about their patients.
In the three years since section 60 was passed, there has been absolutely no evidence that it has been misused in this way, but there is still a suspicion that PIAG could damage the interests of patients by enabling inappropriate access to their information. There have also been criticisms from quite different quarters. Academic researchers (particularly cancer researchers) have argued that PIAG is just another measure frustrating their ambitions to undertake clinical research of major public value.
They have argued that it is impractical to seek patient consent in some circumstances (for example, when giving a diagnosis of cancer or other serious illness) and that research will be delayed or stopped altogether if this requirement is strictly observed.
The researchers claim, too, that studies which have less than 100 per cent coverage (because some patients have exercised their right to opt out) would be invalid and this would thwart important discoveries.
Some eminent epidemiologists have recently complained about what they describe as the 'pointless obstacles' researchers face when seeking access to medical records.
1Quite different objections have come from those who argue that PIAG will delay the shift towards a 'consent culture' if it gives researchers a way around legislation protecting patient confidentiality and reduces the incentive actually to talk to patients and ask for their consent.
What is the reality and are these criticisms of PIAG justified? First of all, the group does not believe that section 60 powers are unnecessary or restrictive.When PIAG was established it was estimated there were around 250 disease registers, more than 50 public health registers and several thousand research projects in which identifiable data was being used.
There was a huge amount of data being processed through the NHS for other than immediate clinical purposes or clinical audit which was not anonymised and where intimate information about individuals was in circulation.
It is clearly essential to bring some order to this chaos and to protect the privacy of patients.
Common law, the Data Protection Act 1998, and the Human Rights Act 1998 have all helped to set the boundaries around access to medical records and have established some fundamental principles about confidentiality and consent.
Nevertheless, there are clinicians and academics who believe that seeking consent to using patient information is too burdensome, time-consuming and unnecessary. PIAG has strongly challenged this view. It does not accept the argument that consent cannot be sought from people with particular diagnoses (for example, cancer or mental illness) or from parents of children with serious illness, or that the process is too intrusive.
In many cases these individuals are suffering from long-term conditions and they have frequent contact with the NHS.
The opportunity to seek consent does not, therefore, occur just once. There can be a number of different occasions on which to explain the purposes of disease registers or research studies and to seek patient participation.
Second, we do not agree that researchers or clinicians should be exempted from seeking consent just because some patients may refuse it.Although there may be situations (for example, in the case of rare diseases) in which it is essential to have 100 per cent participation in a study to eliminate bias, there will be others where this is unnecessary.
PIAG expects to see the case for the necessity of 100 per cent participation argued, not asserted.
Third, consent is not the only option in many cases.
Anonymisation (or pseudonymisation, in which identifying information is replaced consistently with pseudonymous information) of patient data may be a good practical alternative. This could be done using the NHS number, although it is still underused on patient records. In the near future, the 'secondary uses service' - which the national programme for IT will be creating - will eliminate the need for researchers and others not directly involved in clinical care to use identifiable information about patients in most circumstances.
PIAG was created as a temporary measure to facilitate essential work until such time as consent and anonymisation procedures had become firmly embedded in the NHS. The national programme for IT has great potential to overcome many of the problems with which PIAG is currently wrestling, although questions of consent and confidentiality are central to the programme, too. But critics of PIAG and the IT programme cannot turn back the clock.
The arguments against informed consent sound weaker and weaker in an NHS which is committed to openness and transparency as well as to patient empowerment.
There are some challenging ethical and technical issues which need to be addressed in handling sensitive patient information, but sticking with the status quo is not an alternative.
There are still some completely unacceptable uses of patient data in the NHS and in the academic world. PIAG has not addressed them all by any means, but it has helped to sensitise at least part of the healthcare and academic community to the importance of handling patient information with respect and within the limits of the law.
Professor Joan Higgins is chair of PIAG and director of the Manchester Centre for Healthcare Management.
1 Peto J et al. Data protection, informed consent and research. BMJ 328(7447):1029.