Julian Sheather on opening the data floodgates

The Coroners and Justice Bill is currently in Committee stage in the UK House of Commons. Section 152 of the Bill amends the Data Protection Act. It gives ministers of state the power to enable the sharing of any data that falls within their sphere of responsibility. It defines data sharing as both “the disclosure of data between two or more persons,” and “the use of data for a purpose other than that which it was originally intended.”

It also permits the minister to “remove or modify any legal barrier to data sharing.”  This, states the relevant explanatory note “could be by repealing or amending other primary legislation, changing any other rule of law (for example, the application of the common law of confidentiality to defined circumstances), or creating a new power to share information where that power is currently absent.”

The common law duty of confidentiality; the confidentiality requirements of the Data Protection Act – and presumably the venereal disease regulations and the confidentiality clauses of the Human Fertilisation and Embryology Act – all could be set aside. Just in case there is any doubt that the Clause applies to medical records, the Explanatory Notes make it clear: “if an order allowed NHS Trusts in England to share patient data for the purposes of medical research, the data-sharing exercise relates to health matters, and so the appropriate Minister would be the Secretary of State for Health.”

If this Bill passes on to the statute book unamended, it could introduce a sea-change in the control and processing of personal health data. The presumption that decisions relating to the sharing of identifiable health information for research should be made by the person to whom the data refers will no longer hold: the decision could be made my ministerial fiat. The presumption of medical confidentiality could itself fall, forcing the relationship between doctor and patient to be redefined. Currently detail is thin, and such a view may prove to have been alarmist, but make no mistake: the powers as currently drafted are breathtaking in their sweep.

Although the Bill relates to all data, the reference to medical research in the Explanatory Notes is not accidental. Behind the Bill lie the recommendations of a 2008 report into data sharing by Richard Thomas, the Information Commissioner, and Dr Mark Walport, Director of the Wellcome Trust. According to the report, the web of law and practice surrounding confidentiality, in particular the requirement to seek consent for any disclosure of identifiable information, is seriously impeding medical research, and must be set to one side.

There is no doubt that medical research is a vital public good. Without high quality ongoing research there can be no improvement in health care. The development of a national electronic database of health records is also creating an unparalleled opportunity to access high quality health data and the research potential is vast.

Against this, however, has to be set the public interest in a confidential health service. Without a strong presumption of confidentiality people will not disclose sensitive information to their doctors; worse still, they may not access health services at all. It is to protect this primary purpose that both the General Medical Council and the British Medical Association (BMA) support the presumption of consent for the disclosure of identifiable health data.

Where public goods compete, a certain amount of balancing is required, and reasonable disagreements will exist as to where the fulcrum should lie. There are good arguments made, for example, that a presumption that data will be shared could be an acceptable feature of a free public health service, while permitting an opt-out for those whose opposition runs deep. The government is also trying to offset potential harms by setting up safe havens to store data and a system of honest brokers and accredited researchers to ensure legitimate access. But serious reservations persist.

Critics point out that confidence in the government’s ability to manage sensitive data is not just low, it is subterranean. Concern would be more muted if there was confidence that the data would be used for high quality medical research, but this data is valuable and commercial interest is high.

Where issues are this sensitive, diplomatic skill is required. The confidence of the public and of the relevant professions has to be maintained. For there is a doomsday scenario. If too much confidence is lost, and patients do not confide in their doctors, not only will individual health suffer – the very data that research requires will cease to be reliable. The search for a balance of interests in this area is therefore vital, but a government that arrogates to itself such sweeping powers without engaging those effected, and in the absence of essential detail, will have an uphill struggle to find it.

Julian Sheather is ethics manager, British Medical Association.

See also:

Editorial: Amendments to the Coroners and Justice Bill