Patient Information Advisory Group (PIAG)
Background
The Government
has made it clear that informed consent is the fundamental principle governing
the use of patient identifiable information by any part of the NHS or research
community. The NHS Plan proposed to develop a patient centred service where information
is shared between all those involved in delivering or developing care presents
an opportunity to make the best possible use of patient information. But the informed
consent of patients must underwrite that objective. Alternatively, and this may
be a better solution in many cases, 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: to change the culture and to move to systems of using
patient identifiable information based upon the informed consent of patients.
The law
Although this policy direction has an ethical basis, there are important
legal considerations. Patients provide information about themselves in confidence
and where information is held in confidence, 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 the private life of an individual to a
test of necessity. Guidance from the General Medical Council, the Medical Research
Council, the British Medical Association and draft guidance from the office of
the Information Commissioner reflect the evolving legal position and reinforce
the requirement for consent.
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.
How it works
Proposals will be developed by the Department of Health or by
those wishing support in law for the processing of information. A standard approach
to presenting proposals is being developed and will be communicated to interested
parties over the summer. The Act requires proposals to be considered by the Advisory
Group termed the Patient Information Advisory Group and for many proposals will
also require wider consultation. The Patient Information Advisory Group's
(PIAG) key responsibilities will be: - To advise the Secretary of State
on regulations which should be made under Section 60 of the Health & Social
Care Act
- To advise the Secretary of State as required on the use
of patient information and other NHS information
The advice of the
PIAG must be published. Resulting regulations must be laid under affirmative process
(debated in Parliament by each House).
It is worth noting that the passage of the Health and Social Care Bill
provided clear evidence of the strength of feeling, particularly within
the House of Lords, about the perceived erosion of patient rights. PIAG's
role, therefore, will be to scrutinise carefully applications to use patient
identifiable information made under section 60 to ensure the criteria
are met.
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