Draft Health Service (Control of Patient Information) Regulations 2002

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Mr. Heald: Paragraph 4 of regulation 3 states:

    "Where the Secretary of State considers that it is necessary to process confidential patient information . . . he may give notice to any body or person . . . to require that body or person"

to produce it. Where is a serious epidemic or cataclysmic crisis mentioned there? It says nothing whatever about such a crisis; it refers only to when the Secretary of State thinks it necessary.

Ms Blears: The hon. Gentleman knows as well as I do that when Secretaries of State take decisions, they have to do so in accordance with the vires of the law and decisions have to be reasonable. They have to take all relevant considerations into account and action is likely to be taken against them if their

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decisions are irrational. The hon. Gentleman knows that a well-established legal framework helps to ensure that the decisions taken are reasonable. Several hon. Members rose—

Ms Blears: I want to move on to the second part of the regulations. [Interruption.]

The second part of the regulations, usually referred to as class support, outlines a small number of potential justifications for limited access to confidential information where it is likely to be impractical to gain consent. The need for limited support is service wide and each and every example could not realistically be brought before this House. I am told that literally thousands of examples of small-scale information exist in the service at present. However, we want to ensure that even that limited use of information is brought within the legal framework specified in the second part of the regulations. It is proposed that responsibility for approving class support should rest with the Secretary of State, guided appropriately by the independent patient information advisory group.

Specifically, class support might enable staff to access records in order to remove names and addresses and other identifying details. They must have access in the first place to anonymise the information. In the near future, but not currently, electronic records will be able to do that automatically. Class support might allow records to be checked in order to identify suitable candidates for research or to check the address of someone who has provided a tissue sample. That enables researchers in each case to approach the patient concerned to seek consent before including the records or tissue sample in a research project.

Where analysis requires precise geographical locations—for example, to assess the effects of living close to power lines or landfill sites and any potential links to a disease—class support might be provided. Where the only reason to process strong identifiers is to enable information from separate sources to be linked—for example, to link death registration information with health records, or to enable staff to go back to source their data and validate the information—class support might again be required. When there is a need to monitor the quality of care and treatment, which everyone would agree is vital, class support can give legal cover to people involved in that area of work. Until now, they have not had the comfort of legal cover and could be exposed to litigation.

Dr. Harris: The class support issue is one thing that worries me about the regulations. In the example that the Minister gave, the class support approach was used to discover whether a connection existed between living under overhead power lines and specific diseases. An alternative approach would be to create a registry for the disease itself, as the chronic disease registry attempted to do through the Department of Health, although its proposal was

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rejected. Surely, we should not create another way to achieve the same end when an established way already exists, which the Minister supports in the case of cancer and infectious diseases—or, at least, in the case of Public Health Laboratory Service-related diseases. Does the Minister recognise that a potential duplication exists, which worries those of us who do not want the already wide class support approach to become too wide?

Ms Blears: I understand the hon. Gentleman's point, but obtaining the information may not come in the context of a registry approach for specific issues. Particular parts of research may have such links, but not within the overarching framework of a registry. Therefore, no specific application would be made for a registry. We need to maintain flexibility to be able to respond to specific applications that come through the system, which might be narrow and not particularly wide-ranging.

As the hon. Gentleman said, an application was made to the patient information advisory group for generic register cover: not only for cancer registries but for registries generally. It is evidence of PIAG's robust approach that it refused the generic application, saying that it was not specific, robust or rigorous enough. PIAG requested that the applicant proved why it could not use anonymised information, why it needed section 60 support, what plans it had to move towards encryption and anonymisation and how the information would be disposed of. PIAG was extremely rigorous and erred, if anything, on the side of caution in demanding that the applicant prove its case and jump all the hurdles. Applicants are not given carte blanche to use confidential information; they must fit the parameters very closely to receive PIAG's support.

Dr. Fox: If the PIAG is so rigorous and the Government want transparency, why does the group not have a decision-making role rather than a purely advisory one in relation to class decisions?

Ms Blears: The PIAG is the statutory independent watchdog, but the Secretary of State should be responsible for decisions that are made with the PIAG's advice. At the end of the day, the Secretary of State must be accountable for decisions. The PIAG will work to set up the system, the criteria and the way in which applications are considered, ensuring that no element of arbitrary decision making exists in the process and that decisions are based on proper reasoning.

Other people who apply for support will want to know what criteria they need to meet, whether it is a waste of time for them to apply and whether their application will be automatically rejected. They will want to know how they can set up the application to ensure that they have covered everything that the PIAG will consider.

I draw to hon. Members' attention the application that was made to PIAG by the Health and Safety Executive, which wanted to study information related

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to occupational diseases and hazards. That application was rejected because it was not detailed enough, did not have a robust approach and did not say why it could not use anonymised information. The Health and Safety Executive was told to go away and come back with a more narrowly focused application.

Mr. Grieve: I understand the reason for wanting to use information from identifiable sources in order to extrapolate data. However, a moment ago, I asked the Minister a specific question about regulation 2, which allows information to be provided where

    "it is required for the counselling and support of a person".

Looking at the Health and Social Care Act 2001, I see that section 60(5) in part 5 states:

    "Regulations under subsection (3)"—

which is what we are dealing with here—

    "may not make provision for requiring the processing of confidential patient information solely or principally for the purpose of determining the care and treatment to be given to particular individuals."

That seems to make eminent sense, but how is it reconcilable with regulation 2(1)(e), which would allow precisely that—not for the purposes of treatment, because that is prohibited, but, more extraordinarily, for the purposes of providing counselling and support?

Ms Blears: The important words are "solely" and "principally." The regulations are not specifically directed at treatment, but neither are they limited to databases. In its submission on behalf of patients, Cancer Relief Macmillan Fund says that it welcomes the fact that the regulations will provide support for

    "health and health related care purposes. This will help ensure that the cancer registry can be used to contribute to medical research in its broadest sense (e.g. research into the outcomes of nursing interventions or that which aims to assess quality of life issues)."

That extends beyond the simple remit of numbers, statistics and databases to trying to access information relating to people's quality of life.

Mr. Grieve: I am sorry to return to the issue, but my reading of section 60(5) of the Health and Social Care Act, the principal Act, is that it contains a specific prohibition on the processing of patient information

    "solely or principally for the purpose of determining the care and treatment to be given to particular individuals."

So if an individual says, "I need information about my grandmother's medical history to determine my treatment", the Act would prohibit the handing over of that information. However, although that is prohibited under the Act for the purposes of treatment, which one might have thought would include counselling and support, it seems to be allowed under the regulations. Have I misunderstood the Act? Can we forget about whether the regulations have been welcomed by some organisation, because I want to know whether my reading of the legislation is correct?

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Ms Blears: The hon. Gentleman dismisses the contribution from Cancer Relief Macmillan Fund too lightly, because it is concerned that the regulations should support the provision of information that supports the provision of health care and assesses quality of life issues, the outcome of nursing interventions, quality of care, as well as incidence and prevalence. The regulations do not deal with determining what sort of care people should receive. They allow for information to be obtained from the registry about prevalence and incidence, which would inform the provision of care and determine where there is a need for care. The information that we gather about where cases of cancer occur and what kind of family conditions can cause cancer will help to plan provision, where there is a need for counselling and support.

For example, there are huge variations in specialist adult palliative care, and we do not have information about access to specialist palliative care in the west midlands, compared with access in the north-west or north-east. The information base is patchy. We want to be able to collect all that information, so that we can develop services and provide people throughout the country with equal access. The same issue applies to chemotherapy. We do not have information about who can access chemotherapy in different parts of the country.

Mr. Grieve: I apologise to the Minister for taking a legalistic approach because I understand the Government's intentions, which are clearly honourable in principle. I interpret the Act as providing a specific exception in relation to the treatment of an individual. That is incompatible with stating in the regulations that the provision cannot apply to treatment but can apply to counselling and support. Indeed, I venture to suggest that the distinction is untenable. What legal advice has been sought? It seems that on that basis the regulations are probably ultra vires.

Ms Blears: If the hon. Gentleman looks closely at section 60(5), he will find that the prohibition relates to determining care and treatment and deciding what treatment should be provided. It is therefore not appropriate to do that.

Regulation 2(1)(e) relates to ensuring that we have the information for appropriate provision to be made—not determining the treatment that a person should have, but ensuring that appropriate treatment is provided. Determining and providing are two distinct and separate issues. We are discussing providing information not to enable a diagnosis to be made about the sort of care that is appropriate but to enable people to provide appropriate care and ensure that it is in the system. I appreciate that that is a complex distinction, but there is a distinction between those two parts of section 60(5) and regulation 2(1)(e).

Dr. Harris: The hon. Member for Beaconsfield and I are both struggling over section 60. Subsection (5) refers to regulations made under subsection (3), but

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in the copy of the Act that I read, subsection (3), like subsection (5), refers to regulations made under subsection (3). Section 60 also refers to subsection (4)(c), which does not seem to exist. Perhaps the problem goes wider, or perhaps the hon. Member for Beaconsfield and I do not understand the derivation of the regulations.

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Prepared Wednesday 15 May 2002