Government response to the Data Sharing Review
The Government response to the Data Sharing Review was published on 24 November 2008.
The responses to three of the recommendations made in the Review are of particular relevance to the use and sharing of personal information for research:
Response to recommendations 15 and 16
We support these recommendations. Government is committed to handling data in accordance with the DHR [Cabinet Office - 'Data Handling Procedures in Government' report 2008], which put in place a set of guiding principles for putting the appropriate protections in place. Government recommends that individual sectors need to design approaches that are appropriate for their area of business within the general framework of data security already laid down by the DHR. A balance needs to be struck by any organisation between the importance of privacy and security with the need to drive forward essential research and analysis of performance data in the public interest.
…In relation to the Department of Health in England, we accept the recommendation that:
- 'safe havens' are developed, as an environment to assist with appropriate processing for the purpose of population-based medical research and statistical analysis for medical purposes, to minimise the risk of identifying individuals
- a system is devised to ensure that only accredited people do work within safe havens.
Through the Research Capability Programme, established via the NHS Connecting for Health in 2007 programme, the Department of Health is working with the Information Centre for Health and Social Care to develop safe havens. They will be designed to enable appropriate processing for health research purposes of patient information and other data derived from patient information.
The aim is to provide a secure environment in which suitable investigators and research professionals can work under conditions of confidentiality, with expert support from health professionals and staff who owe a duty of confidentiality equivalent to that of a health professional.
In this context, the Government will commission a code or codes for the use of safe havens, and a scheme for accrediting researchers. The Government will continue to consider the appropriate legal structures for the different types of processing that might in future be carried out using 'safe havens' and in relation to the use for non-medical purposes of data derived from patient information.
One aim of the Research Capability Programme is to determine principles to enable the use of information derived from care records alongside other datasets under conditions that protect identifiable personal and confidential information. The Department of Health will continue to work with Data Controllers and academic and other partners to achieve this, through safe havens where necessary.
Response to recommendation 17
The Government has announced plans to ensure that patients, from every part of the country, with any illness or disease, are made aware of research that is of particular relevance to them; and to enable them to choose whether to take part in appropriate clinical trials.
The Department of Health will develop a system to allow approved researchers to work with healthcare providers for this purpose, under a duty of confidentiality equivalent to the duty owed by health professionals. The Department will develop mechanisms to help healthcare providers operate the system consistently, and will ensure they work with the employers of the approved staff to deal effectively with any breaches of confidentiality. The independent National Information Governance Board will monitor the operation of the system.
The Research Capability Programme in NHS Connecting for Health will develop secure ways to speed up the operation of the system and reduce the need for approved staff to process identifiable patient information.
In relation to the NHS in England, the draft NHS Constitution includes pledges about access to information and informed choice. The Handbook to the draft NHS Constitution explains how these pledges will apply to research, stating:
Research is a core part of the NHS because it enables the NHS to improve the current and future health of the population. Therefore, the NHS will do all it can to give patients, from every part of the country, with any illness or disease, a right to know about research that is of particular relevance to them and, if they choose, to take part in approved medical research that is appropriate for them. Patients can therefore expect that a health professional or a research professional who owes the same duty of confidentiality as a health professional may use care records, in confidence, to identify whether they are suitable to participate in approved clinical trials. Appropriate patients will be notified of opportunities to join in, and will be free to choose whether they wish to do so, after a full explanation.
In relation to the research that it supports through the National Institute for Health Research (NIHR) in England, the Government will:
- require NHS research sites to display standard notices drawing attention to the way personal information may be used for research
- ask the National Information Governance Board to amend the NHS Care Record Guarantee so that it draws appropriate attention to the use of personal information for research and analysis to improve health and care
- ensure wide distribution of the NHS Care Record Guarantee when revised
- require NHS organisations to publish their research Privacy Policies, research data-sharing practices, and lists of the organisations with which they share personal information for purposes related to research
- prepare standard explanatory material on research uses of personal information, making it publicly available through NHS Choices, and available to NHS research sites for local use
- develop better mechanisms to record individual patients’ objections to research uses of information that identifies them, in a way that enables any NHS research site to respect their wishes.