Data sharing: privacy concerns and public attitudes

16 March 2009

How extensively should governments be able to share personal data without consent for the public good? This question has vexed many of those involved in medical research who have sought more effective means of carrying out large scale research studies without the need to take consent from every patient. Issues arising from the use of personal data for medical research were the subject of a review by the Academy of Medical Sciences in 2006, and it was widely acknowledged that the complex legal and regulatory framework arising from statute and case law, created widespread uncertainty about the limits to legitimate sharing. These concerns, coupled with some gross lapses in security which caused major losses of data, caused the Government to commission a report from Richard Thomas, (Information Commissioner) and Dr Mark Walport (Director of the Wellcome Trust) last year. Their subsequent Data Sharing report (published in July 2008) contained robust criticisms of the current position arguing that 'the law and its framework lack clarity, responsiveness and bite' and set out a series of recommendations for improving systems for data sharing which were broadly accepted by the government.

One of these recommendations, namely that a fast track procedure should be established 'where there is a genuine case for removing or modifying an existing legal barrier to data sharing' formed the basis of data sharing clauses in the Coroners and Justice Bill which has just completed its committee stage in the House of Commons. However, the scope and breadth of those clauses have been roundly condemned as being disproportionately wide in scope, and even that they would allow government to ride roughshod over the protections contained in existing national legislation (such as the Data Protection Act) or even the Human Rights Act itself, particularly if the clauses were used to deliver large scale policy initiatives such as the National DNA database or the National Identity Register. Moreover, critics argued, the safeguards contained in the draft legislation, namely that the Office of the Information Commissioner could police any applications and determine whether they were 'necessary and proportionate' were inadequate to quell worries that these provisions might cause evaporation of public confidence. Indeed these fears were compounded by the fact that the safeguard mechanism of issuing assessment notices by the Office of the Information Commissioner was limited to the public sector and not private and voluntary sectors.

Significantly Sir Mark Walport, a joint author to the review which had initiated these reforms stated in a written Memorandum to the Committee scrutinising the Bill that 'the drafting goes wider than the precisely defined circumstances' defined in our Recommendation’. The Office of the Information Commissioner also argued that 'the Bill's information-sharing provisions are too wide, and its safeguards too weak'.

For medical research charities, it was ironic that the most trenchant critics of these provisions in the Bill (such as Liberty) used the example of sharing medical records without consent as one of the abuses which were likely to flow from these provisions, whilst the Thomas and Walport Data Sharing Review had made a set of separate recommendations which addressed the difficulties of secondary research, which have not been taken forward by Government. On 3rd March, a group of UK medical organisations including the British Medical Association, the Royal College of GPs, the Royal College of Surgeons, the Royal College of Nursing, the Faculty of Public Health, the Academy of Medical Royal Colleges, the Medical Defence Union, and the Medical Protection Society wrote to Justice Secretary Jack Straw to protest about clauses in the Coroners and Justice Bill that would allow ministers to ’remove or modify any legal barrier to data sharing‘ (see Economist report).

Although clause 152 was intended to balance the public interest against the privacy of individuals, doctors were concerned that it would violate patient confidentiality, and others feared that it could allow the government to disclose personal data to third parties. This provision will now be dropped from the Bill, and a modified version introduced in the future; a spokesman for Jack Straw said: "Jack recognised the strength of feeling and he recognised that the clause was drafted in a way that was too wide, and so needed to be looked at again” (see Telegraph report).

Meanwhile, UK medical charities the British Heart Foundation, the Wellcome Trust, and CancerResearch UK have called for more public participation in discussions about the use of patient data. They warned that increasing levels of regulation are necessitating the devotion of disproportionate resources to gaining consent and access to medical data, with diminishing returns in terms of recruitment of suitable subjects for clinical trials, stifling medical research. Wellcome Trust Director Mark Walport said: "The big challenge is in gaining public confidenceabout access to electronic patient records. There has to besome form of partnership to help that debate and move it forward” (see BMJ news report), adding that it was important for the public to understand the integral role of health care providers in clinical research. A previous PHG Foundation consultation response to the 2008 Data Sharing Review made similar points.

Moving to a global perspective on data-sharing, Nature recently reported on plans to develop a non-profit, open-access research platform called Sage with a view to creating comprehensive biological databases for scientific research, to support the development of more predictive disease models.The scientists from Rosetta Inpharmatics say that their long term vision is of an open-access platform for “research scientists, clinicians and maybe even patients” to access data and to contribute their own information and findings to further extend and improve the database along the lines of Wikipedia (see Nature news report).

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