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FIPR response to the Consultation on Proposals for use of Section 60 Powers

  1. The Foundation for Information Policy Research is an independent body that studies the interaction between information technology and society. Its goal is to identify technical developments with significant social impact, commission research into public policy alternatives, and promote public understanding and dialogue between technologists and policy-makers.

    The confidentiality of personal health information has been contentious in the UK for many years, and has caused problems in many other countries too. Large sums of money have been spent on systems that fail to protect confidentiality, both here and overseas. For background we refer to the FIPR response to the last confidentiality consultation:

    which we include herein by this reference.

  2. FIPR strongly opposes the proposed revision of the Health and Social Care Act regulations. This revision, if enacted, will in practice eliminate the principle that patients must give informed consent for the sharing of their personal health information.

  3. The regulations now proposed are contrary to assurances given during the passage of the Act through Parliament, including undertakings by John Denham that the bill would be used to protect patient privacy. There was a separate undertaking by Alan Milburn, in the context of the Alder Hey scandal, that the days of the old paternalistic NHS were over and that patient consent would be paramount in future. Section 60 was presented to Parliament as a temporary measure that would be used only while proper consent and de-identification mechanisms were being developed and implemented.

  4. The proposed regulations are also in stark contrast to the Human Tissue Bill now before Parliament, which entrenches the requirement for consent for the use of pathology specimens. If it is practical, as now argued in that context by ministers, for doctors to obtain consent for tissue sample collection, then it is also practical to get similar consent for records to be used in research.

  5. UK governments have a poor record of managing ethical risks in the context of medical research. Lax oversight of animal testing laboratories in the 1970s led to the rise of animal rights terrorism, which has recently (inter alia) forced the abandonment of the proposed centre for primate research in Cambridge. A similarly cavalier attitude to tissue sample collection caused the Alder Hey scandal, which has stifled research in pathology and led to the Human Tissue Bill (which many scientists consider to be overprotective).

  6. A third disaster is now in the making. The proposed powers will enable the Secretary of State to grant researchers essentially unfettered access to personal health information. Combined with current proposals to collect GP data centrally, as well as the hospital data already collected in HES and Clearing, this appears to promise a feast for records-based research. It is predictable that record access will not be restricted to cases, such as Biobank, where consent has been obtained, or where at least a good-faith effort has been made to make patients aware of the uses to which their data may be put. It is equally predictable that, at some time in the future, the public will suddenly become aware that medical privacy is no more. We would not like to speculate on the nature of the incident which will make this clear to everyone. We are (sadly) confident that when the public does become aware of the change, the reaction will be strongly negative and highly damaging. The short feast will be followed by a much longer famine. The administration of healthcare in the UK will also be impaired by the inevitable loss of trust.

  7. FIPR also points out that the previous Information Commissioner considered the management of personal health information in systems such as HES and Clearing to fall seriously short of the requirements of Data Protection law. During the debate in the Lords, health minister Lord Hunt made clear that the bill would not, for example, exempt the Commission for Health Improvement from the requirement to comply with data protection law. Indeed, this was his main argument against Conservative and Liberal peers who wished to amend the bill to provide stronger confidentiality protection. FIPR therefore believes it is ultra vires for the Secretary of State to issue regulations that have the apparent purpose of allowing health administrators to escape their data protection obligations.

  8. The regulations also breach the Declaration of Helsinki on ethical principles for medical research, and contravene the Council of Europe recommendation no R(97)5 on the protection of medical data, to which Britain is a signatory.

  9. The consultation asks what practical alternatives there are to processing information `if section 60 support is not provided'. The short answer to that is that the government is in a hole, and must stop digging. The unlawful processing of data by HES and Clearing was brought to the government's attention by the BMA in 1996, and yet rather than redesigning health information management systems to comply with the law, ministers have continued to press for further centralisation and yet more intrusive, universal surveillance.

  10. The consultation also asks whether the review process is sufficient; FIPR believes that the membership of the PIAG should be strengthened and its operation made more transparent (the supporting documents for its meetings should be published, as well as the agenda and minutes; and all papers should be published promptly).

  11. A further question is whether more information should be published; FIPR strongly supports this. The confidentiality issue has become a festering sore, and sunlight can be a good disinfectant.

  12. Finally, the report asks what additional safeguards should be incorporated. FIPR believes that in the rare cases where neither consent nor the use of de-identified data is feasible, then two requirements must be imposed on the party seeking access to records. First, the party seeking access must consult a sample of the patients affected and establish that a large majority of them did not object to the proposed use. Second, public notice must then be given of the proposed use, so that affected patients have a fair chance to object and to have their records excluded from the study.

  13. FIPR therefore welcomes the Prime Minister's statement yesterday that, in a third term, his government would reverse the trend towards centralisation. We suggest that the DoH act as if he were speaking the truth. The NHS must cease and desist from centralising all personal health information, leave the information in the hands of its natural custodians (the general practices, hospitals or other carers), redesign payment systems so that settlement occurs locally, and delete transient administrative data (such as payment details) promptly.

  14. The guiding principles for regulation in this field must be ethical, and founded on informed consent. They should be enunciated clearly and in public, and applied in a consistent and joined-up way across health research and administration, so that the law continues to uphold the principle of patient consent equally in the field of medical records and that of tissue sample collection.


  1. NHS Confidentiality Consultation — FIPR Response []
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