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Using patient data

Background to the Patient Information Advisory Group (PIAG)

The Government has made it clear that informed consent is the fundamental principle governing the use of patient identifiable information in the NHS. The NHS Plan proposed to develop a patient centred service where information is shared between all those involved in delivering or developing care, presenting an opportunity to make the best possible use of patient information. But the informed consent of patients must underwrite that objective. Alternatively, where possible, information which no longer identifies individual patients must be used.

Ministers have taken a very public stand on the issue. In response to the Royal Liverpool Children's Inquiry they said that :-

"The traditional paternalistic attitude of the NHS, that the benefits of science and research are somehow self-evident, was no longer acceptable."

The challenge to the NHS was twofold: change the culture and move to systems of using patient identifiable information based upon informed consent.

The law

There are also important legal considerations. Patients provide information about themselves in confidence and where such information is held, common law provides no other reliable justification other than informed consent for use of the information in a patient identifiable form. Further, the NHS must comply with the Data Protection Act 1998 which requires certain information to be provided to patients and the Human Rights Act 1998 which subjects any invasion of an individuals private life to a test of necessity.

The problem

There are also situations where informed consent cannot be obtained. For example, important research projects may involve tens of thousands of patients where contact would be impracticable. The essential nature of some of this research means that the public good outweighs issues of privacy. Some patients are not capable of giving consent, but the health service still needs to know about them and their conditions. Sometimes excluding those who refuse consent might bias data collection to the extent that it loses all value.

The solution

Section 60 of the Health and Social Care Act 2001 provides a power to ensure that patient identifiable information needed to support essential NHS activity can be used without the consent of patients. The power can only be used to support medical purposes that are in the interests of patients or the wider public, where consent is not a practicable alternative and where anonymised information will not suffice. It is intended largely as a transitional measure whilst consent or anonymisation procedures are developed, and this is reinforced by the need to review each use of the power annually.

:: Caldicott report

The December 1997 Caldicott Report identified weaknesses in the way parts of the NHS handled confidential patient data.

The report made several recommendations, one of which was the appointment of Caldicott Guardians, members of staff with a responsibility to ensure patient data is kept secure (see Caldicott Manual for Guardians, Nov 2006).

Please note that the NHS Confidentiality Code of Practice now provides the most up-to-date guidance on patient confidentiality.

December 1997 Caldicott Report Caldicott Manual for Guardians NHS Confidentiality Code of Practice

:: Further information

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