Health and Social Care Act 2012 Section 251 and Wales Information
Governance Board
Author: Jane Evans Information Governance Manager
Date: March 2012
Version: 0b
Purpose and Summary of Document:
To inform the committee on the current position Public Health Wales is in
regard to section 251 approval and potential future changes in this
approval.
Sponsoring Executive Director: Mark Dickinson, Executive Director of
Planning and Performance.
Who will present: Jane Evans
Documents attached: Briefing paper on how Wales will take forward
requirements of Health and Social Care Act 2012 – section 251 and Wales
Information Governance Board.
Date of Committee meeting: 20 March 2013
Committee/Groups that have received or considered this paper:
N/A
Please state of the paper is for:

Discussion
Decision
Information

1
Purpose
The divergence of NHS Wales from NHS England means that Wales must
take ownership through Welsh Government to ensure that it has in place
mechanisms to take forward legislative enactments and requirements.
One of these is the necessity for Wales to have a recognised body to
ensure that Information Governance is nationally regulated, that the legal
requirements concerning Section 251 support of the Health & Social Care
Act 2012 are met and that other issues such as the current consultation of
the EU General Data Protection Regulation are correctly channelled.
2
Recommendation(s)
The Committee have requested a regular update on the situation and are
asked to note this update.
3
Committee Members are asked to:
Note the concerns of Public Health Wales:
 Section 251 support has been a concern for a number of years
NWIS is taking forward the establishment of a body which can cover the
requirements of Section 251 support, and is engaging with Welsh
Government, through the Minister for Health and Social Services, to
ensure this body has the necessary regulatory powers.
4
Introduction
Section 251 of the NHS Act 2006 (originally enacted under Section 60 of
the Health and Social Care Act 2001), allows the common law duty of
confidentiality to be set aside in specific circumstances where anonymised
information is not sufficient and where patient consent is not practicable.
For example a research study may require access to patient identifiable
data to allow linkages between different datasets where the cohort is too
large for consent. This would require time limited access to identifiable
information where gaining consent from a large retrospective cohort would
not be feasible and would require more identifiable data than would be
necessary for linkage purposes.
An application for Section 251 support requires explicit details about data
flows and full justification about why each identifiable piece of information
is required and how this allows the aims of the study to be met. Evidence
that no other reasonable alternative, such as anonymisation or consent,
exists will be assessed via the application form.
Public Health Wales
S251 briefing paper for IGC
Any Section 251 approval will be subject to an annual review in order to
assess that the applicant has met the conditions or report plans, and/or
action towards meeting them. It is the applicant's responsibility to ensure
that this is submitted on the anniversary of approval.
5
Public Health Wales’ Section 251
applications
PHW has successfully applied for Section 251 support for:
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CARIS
Bowel Screening Wales
Breast Test Wales
Cervical Screening Wales
Cervical Screening Wales HPV Vaccination Evaluation
Newborn Hearing Screening Wales
WCISU are currently covered under a joint UK Association of Cancer
Registries application but will need to apply for separate Section 251
support.
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The problem is the divergence of NHS
England and NHS Wales
NHS Act 2006 sets out mechanisms and legal basis for Section 251
support for England & Wales. The Health & Social Care Act 2012 does not
rescind this but also obscures Wales’ position in respect of the changes
that England is undertaking concerning the mechanisms for obtaining
Section 251 support.
Currently England is working towards these changes (see Appendix).
6.1
Legal basis for processing non-consented person
identifiable data
There must be a legal basis for processing the above. Section 251
applications are subject to annual review and it is likely that there will be
requirements to submit new applications i.e. for a new screening
programme.
The DoH recognises that in the long term Wales must take on the process
for submission, approval and review of Section 251 applications, but that
in order to set up regulations there will be a transition period of 18-24
months.
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Public Health Wales
6.2
S251 briefing paper for IGC
ECC Applications – Research and management
information
There are two distinct areas which may require Section 251 support:
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6.3
Research
Management information i.e. screening programme
evaluation, cancer registration
Research
Research often crosses boundaries. In most cases ethics approval is
necessary. One body should approve for Section 251 support as it would
be seen as too onerous for researchers to have to submit to a separate
such body in Wales as well as one in England. The Appendix explains the
process that Wales would be happy to adopt for Research based projects.
6.4
Management information such as national
databases, screening programmes, cancer registry
activity
Wales has/is taking the following steps:
1. Set up equivalent of National Information Governance Board and Ethics
& Confidentiality Committee (ECC) – Welsh Information Governance
Board (WIGB) and Privacy Advisory Committee (PAC) will mirror
initially the functionality of the English boards.
WIGB/PAC have been in operation for about 12 months. Patrick Coyle
and Dr Tony Calland sit on WIGB and ECC.
2. Brief the Minister for Health and Social Services on the need to ensure
there is a legal basis – regulations
A meeting between the Minister for Health and Social Services and
Chair of WIGB had been set up for January 2013 but was cancelled due
to weather conditions. A briefing paper has been submitted to the
Minister and a meeting arranged for late March to discuss the issues
raised.
3. Welsh Government Legal department must take on setting up the
requirement above. This has been raised in the briefing paper. Welsh
Government Legal department refuses to engage directly with NWIS.
Therefore instruction must come through the Minister for Health and
Social Services.
WG Legal would be required to:
 Transfer Secretary of State powers to Welsh Ministers;
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Public Health Wales
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S251 briefing paper for IGC
Enable those provisions in regulations; and
Formerly establish WIGB and PAC within the regulations.
4. WIGB/PAC to work with DoH/ECC so that will be fit for purpose to take
on responsibility and have due process to grant Section 251 support.
The Head of Information Governance from NWIS is in dialogue with
Department of Health.
5. ECC will expect WIGB/PAC to ensure that applicants have adequate
security and confidentiality measures in place to safeguard the data. In
England this is compliance with Information Governance Toolkit and a
Confidentiality Policy.
Wales is unwilling to adopt the Information Governance Toolkit but
relies on Caldicott Guardians and Caldicott Principles into Practice
(CPiP) annual audit which, like the Toolkit, is a self assessment with the
score submitted to NWIS. Head of Information Governance for NWIS is
currently comparing the Information Governance Toolkit and CPiP to
identify gaps and/or differences so that these can be addressed and
CPiP audit strengthened. It is likely that a Confidentiality Policy could
also be adopted.
7
Next Steps
Public Health Wales is awaiting an outcome from NWIS and will keep the
Committee updated.
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Public Health Wales
S251 briefing paper for IGC
Appendix
Communication re Section 251 function transfer
November 21, 2012
As announced by the Department of Health on the 20 September 2012, all
functions that advise on the use of confidential patient information without
consent, according to regulations made under section 251 of the NHS Act
2006 will transfer from the National Information Governance Board (NIGB)
to the Health Research Authority (HRA) on the 31 March 2013.
Responsibility for approving applications will lie with the Health Research
Authority from April 2013 for research applications; the Secretary of
State for Health will retain the approval function for all other nonresearch applications. Please see the FAQs for details on this change.
Progress has been good since the original announcement and the following
key decisions have been made:
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The HRA has agreed to convene a Confidentiality Advisory Group (CAG)
which will take on responsibility which lies currently with the Ethics and
Confidentiality Committee (ECC);
Six current members of the ECC will transfer to the CAG on the 31
March 2013 to support the establishing chair and ensure a strong level
of continuity – these posts will be re-advertised towards the end of
2013 and appointed to by March 2014;
Recruitment of a further ten CAG members will be completed by
January 2013 (advert due to go out at the beginning of December);
Current staff associated with the function will transfer on or before the
31 March 2013;
The next key step is to appoint the ten CAG members. The HRA will make
these appointments, working closely with colleagues from the NHS
Commissioning Board Authority, Public Health England, the Information
Commissioners Office and others from the Health and Social Care Sector.
Work also continues on ensuring that the advisory and decision making
functions are wholly transparent and fit for purpose. A range of meetings
will be set up with key stakeholders before the end of the calendar year to
discuss the developing design work.
The engagement work will continue in the new year where it is planned to
hold two wider stakeholder events. More information to follow.
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