Council
2-3 November 1999
9a
To note
Draft Guidance: Confidentiality: Providing and Protecting Information
Issue
1.
The delayed publication of the draft guidance Confidentiality: Providing and
Protecting Information.
Recommendation
2.
To note the Committee’s decision to review the new guidance in the light of
developments in the common law, and prepare a further draft of the guidance for
consideration by Council in May 2000 (paragraphs 11-13).
Further information
3.
Jane O’Brien 0171 915 3567 e-mail: [email protected]
Antony Townsend 0171 915 3517 e-mail: [email protected]
Background
4.
On 26 May 1999 Council agreed minor editorial changes to the draft guidance
Confidentiality: Providing and Protecting Information, and agreed that it should be
published and circulated to the profession.
5.
On 28 May 1999 the Honourable Mr Justice Latham handed down his judgment
in the judicial review R and Department of Health ex parte Source Informatics Ltd.
The judgment concluded that the Department was justified in issuing advice that
anonymised and aggregated data was patient confidential and could not be
disclosed without consent from each patient. The judgment also included a
statement that the disclosure of data within the NHS, might be justified ‘in the public
interest’ or on the basis of implied consent, but since these were not matters at issue
in this case, they could not be fully addressed.
6.
Our draft guidance is based on the view that questions of confidentiality are
raised by the disclosure of identifiable data, including the access to data which may
be needed in order to aggregate the data or remove identifying details from it.
However, once medical information is aggregated and/or properly anonymised we do
not regard it as confidential (since its disclosure cannot harm or distress any
individual), and may be used for purposes such as clinical audit, administration and
planning of health services, teaching and research, without consent.
7.
The judgment in the Source Informatics case therefore raised considerable
problems. Even if it is assumed that the judgment allows for the use of anonymised
data within the NHS, it appears to preclude the use of anonymised and aggregated
data for education, training and audit in the private sector, or for research by
pharmaceutical companies or otherwise in any ‘commercial’ environment.
8.
In July 1999 the Association of Community Health Councils (ACHCEW)
obtained an opinion from Mr Richard Gordon QC who advised that our new guidance
encouraged doctors to contravene the common law, as it stands following the
Source Informatics judgment, and for this and other reasons, a judicial review of our
draft guidance, either to prevent its publication, or to force its withdrawal, would be
successful.
9.
In July 1999, the President’s Advisory Committee decided to delay publication
of the new guidance at least until after the Source Informatics appeal had been held.
The PAC also agreed that the GMC should seek to intervene in the appeal, which
will be held on 29-30 November 1999, to advise the court on the problems raised for
doctors by the Source Informatics judgment. We have therefore instructed
Lord Lester of Herne Hill QC to act for us (since Mr Michael Beloff QC is acting for
another party in the case). A submission has been made to the court and we are
waiting to hear whether our intervention will be allowed.
10. At the same time, the Standards Committee has, with the encouragement of
the PAC, continued discussion with the Chairman and Director of ACHCEW and with
the Chief Executive of the NHSE.
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Discussion
11. The views on confidentiality held by us, the Medical Research Council the
Department of Health, and ACHCEW relate principally to the use of data in research,
clinical and financial audit and in the administration and planning of health services.
Most of our new guidance is not therefore in dispute. The areas of dispute relate
principally to different understandings of what constitutes adequate consent in these
circumstances and the circumstances in which disclosures without consent ‘in the
public interest’ would be justified. The claim made in 1998 that our new guidance
encouraged doctors to act unlawfully has resulted in legal opinions being obtained by
all the organisations involved and this has led to emphasis being given to differences
in understanding of the legal position, rather than to the consensus which exists on
the majority of the ethical issues.
12. We have intervened in the appeal of the judgment in the Source Informatics Ltd
case in the hope that the appeal may clarify a number of the legal questions in
relation to the use of both anonymised and identifiable patient data. This should
allow the key organisations to consider together a way forward, based on a common
understanding of where the law now stands.
13. The Standards Committee therefore proposes to review the new, unpublished
guidance in the light of the outcome of Source Informatics appeal, in conjunction with
other interested bodies, including ACHCEW, the Department of Health, the Data
Protection Registrar and the MRC, with a view to revising the guidance for further
consideration by Council in May 2000.
Recommendation: To note the Committee’s decision to review the new
guidance in the light of developments in the common law, and prepare a further
draft of the guidance for consideration by Council in May 2000.
Financial implications
14. The cost of intervening in the Source Informatics appeal will be between
£40,000 - £45,000.
Council/Nov99\confid
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