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Lord Clement-Jones moved Amendment No. 12:

("(4) Regulations under this section shall correspond to section 23(2) and section 23(3) of the Health Act 1999 with respect to the disclosure of confidential information that relates to and identifies a living individual.").

The noble Lord said: The amendment seeks to ensure that the national care standards commission, while carrying out its functions, provides the same standard of safeguard as regards identification for patients in the independent healthcare sector as those provided by the Commission for Health Improvement which are contained in the Health Act 1999. I make no bones about it. We felt that the Minister's response to a similar amendment tabled in Committee was unsatisfactory.

Health information about patients should not be disclosed without proper justification. Personal health information is collected for the provision of care to individual patients, and generally should not be used for other purposes without patients' permission. Information may be used without consent only in exceptional circumstances; for example, where disclosure is essential to avoid a risk of death or serious harm to people and it is not possible to obtain consent. The grounds for disclosure must be of sufficient severity to justify a breach of the duty of confidentiality.

When this amendment was previously moved and withdrawn in Committee, the Minister suggested that it was unnecessary, given that the national care

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standards commission would be subject to the Data Protection Act. However, the amendment seeks to place the national care standards commission on a par with the Commission for Health Improvement, which is, after all, also subject to the data protection legislation and thereby would provide the public with the same safeguards from identification, regardless of whether they are NHS or independent healthcare patients. I believe that the principle of parity of treatment for confidential information purposes is of great importance.

In closing, I ask the Minister whether the Government consider that the Data Protection Act is sufficient to safeguard from identification patients in the independent healthcare sector, and what additional protection will be provided for patients of NHS and primary care trusts by regulations under Section 23 of the Health Act 1999. What is sauce for the goose must be sauce for the gander. Can the Minister advise whether the remit for the recently established National Confidentiality and Security Advisory Board, which was announced on 15th March this year, will include promoting best practice on the confidentiality of patient information in the independent sector? If not, why will NHS patients receive the benefit of regulations and the advisory board, while patients in the independent sector must hope purely and simply that the Data Protection Act is adhered to? I look forward to the Minister's reply. I beg to move.

4.30 p.m.

Earl Howe: My Lords, I believe that the noble Lord, Lord Clement-Jones, has made the case for this amendment most succinctly. I simply do not understand why the national care standards commission should not be subject to exactly the same legal duties with regard to patient confidentiality as apply to the Commission for Health Improvement. I support everything that he said.

Lord Hunt of Kings Heath: My Lords, of course, I accept the noble Lord's concerns and recognise that we had an interesting debate on this matter in Committee. We believe that the amendment is not necessary. It is our view that the commission's right of access to confidential information is already more restricted than that of the Commission for Health Improvement. I say immediately that I believe that all noble Lords will share concerns about the confidentiality of medical records. I am sorry that I was not able to reassure noble Lords on that point in Committee.

I deal, first, with that part of the amendment which relates to Section 23(2) of the Health Act. As the noble Lord explained today, the purpose of that section is to safeguard the confidentiality of personal health information and to ensure that the Commission for Health Improvement can access such information only in limited circumstances: first, where the information is disclosed to the Commission for Health Improvement in a form in which the identity of the individual concerned cannot be ascertained; secondly, where the individual has given his consent; thirdly,

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where the individual cannot be traced; and, fourthly, where the Commission for Health Improvement is carrying out an investigation and considers that there is a serious risk to the health and safety of patients.

If one compares those with the powers of the national care standards commission, one will see that they are much more limited. Clause 29(4) and (5) of the Bill provide that medical records can be inspected only by a medical practitioner or a registered nurse and, even then, only with the consent of the person concerned.

Perhaps I may clarify one further point: Clause 29(1) allows the commission to require any information relating to the establishment or agency which it considers necessary or expedient for the exercise of its functions. However, I assure noble Lords that the powers in subsection (1) could certainly not be used to override the provisions in subsections (4) and (5) regarding the need to obtain consent in relation to medical records.

I hope that I have managed to reassure noble Lords that in relation to the Commission for Health Improvement access to medical records is more restricted under this Bill than it is under the Health Act. I should add that the amendment would also prevent the Government making regulations which would allow the commission to obtain information where disclosure of that information is prohibited by other legislation. This Bill contains no power which would allow the Government to make such regulations.

Therefore, I believe that the amendment is unnecessary. Clause 6 allows the Secretary of State to issue directions to the commission only in relation to the exercise of its functions. Therefore, I assure the House that the Government could not legitimately use that direction-making power to direct the commission to access information which is protected from disclosure by other legislation.

Lord Clement-Jones: My Lords, I thank the Minister for that reply. It seems to veer between "would not be used" (that is, a matter of practice) versus "could not be used" (that is, a matter of law). I am not entirely clear from the Minister's response whether he is saying that Clause 29(1) would not be used--that is, would be governed by subsections (4) and (5)--or whether he is saying that in law it would be unlawful for the commission to access that confidential information.

Lord Hunt of Kings Heath: My Lords, that is the advice that I have received. It is my understanding that in law it could not be used in that way.

Lord Clement-Jones: My Lords, that clarification is helpful. However, I believe that we should look at the Minister's words in Hansard and consider them. This is an important issue and the legal technicalities involved in Clause 29 clearly are of great importance. If the Minister is advised correctly that that confidential information cannot be used except in circumstances as set out in subsections (4) and (5),

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I believe that that would be a satisfactory situation. However, if there is an element of discretion and it is a case of trusting to practice, I believe that that would not be satisfactory. It may well be that if that is so, we shall want to return to the matter at a later stage. In the mean time, however, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Lord Clement-Jones moved Amendment No. 13:

    After Clause 6, insert the following new clause--


(" . There shall be a body corporate, to be known as the Welsh Care Standards Commission, which shall exercise in relation to Wales functions conferred on it by the Assembly in relation to services provided by persons registered under Part II of this Act.").

The noble Lord said: My Lords, I feel somewhat like someone at the front of a juggernaut. Faced with all the amendments which relate to Wales, Amendment No. 13 is small beer indeed compared with what I know that the Minister is due to put forward.

As a convinced devolutionist, far be it from me to expect the Minister to determine what will happen in Wales. However, I believe that a number of parties involved in this matter are seeking some reassurance from the Minister regarding whether or not a separate standards commission is to be set up in Wales and, if so, what its form will be.

I understand clearly that in his own amendment the Minister is attempting to place the powers of the National Assembly for Wales on the same footing as those for the Department of Health. I believe that in Amendment No. 13 the points at issue are: will there be a care standards commission for Wales and what does the Minister believe the practice will be? I believe that a statement from the Minister about his understanding of this point would give some reassurance, particularly to professional bodies which would be involved in implementing the commission. I beg to move.

Lord Roberts of Conwy: My Lords, I have some sympathy with the case put forward by the noble Lord, Lord Clement-Jones, for this new clause which seeks to establish a Welsh care standards commission. As the Bill stands, the registration authority in Wales is to be the National Assembly, which is, of course, a corporate body. Presumably, the Assembly has considered whether it needs a care standards commission and has decided that it does not. Therefore, the question arises as to how Part II of the Bill will be implemented.

I know from conversations with the Minister, the noble Lord, Lord Hunt, that further provisions are to be added to the Bill at a later stage relating to the establishment of a children's commissioner for Wales. I quite understand why those amendments will not be available to your Lordships; namely, that they are the outcome of, or the follow-up to, the publication of the Waterhouse report.

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I hope that we shall have a proper account of the Assembly's deliberations on this particular issue of the care standards commission and that the Minister does not wash his hands of it, as some of his colleagues have been inclined to do as regards other Bills in so far as they relate to Wales. After all, this Parliament is still the primary legislative power and we have a responsibility to ensure that the Assembly, which is not a year old, has the necessary powers to act in the legislation that we provide.

As I understand it, the Assembly must implement Schedule 1, but apart from a reference in paragraph 1 of that schedule to the Welsh council to be established under Clause 51 to deal with social care workers, I can find no cross-reference to Part I, apart from in Clause 8, which refers specifically to charging and training. Therefore, I believe that the noble Lord, Lord Clement-Jones, has done us a service in proposing this new clause.

I press the Minister to tell us whether all this means that the care council for Wales or the Assembly is to take on the responsibilities associated with registration. It is not at all clear. I should be extremely concerned if the Assembly had not yet decided that particular issue. There is certainly a visible vacuum in the Bill in relation to Wales.

4.45 p.m.

Lord Hunt of Kings Heath: My Lords, it is very interesting to have a debate on the situation in Wales. My understanding from the noble Lord, Lord Clement-Jones, is that his amendment is tabled as a probing amendment rather than seeking to constrain the powers of the Welsh Assembly, which I should find to be somewhat at odds with the Liberal Democrat position.

Primary legislation affecting Wales is, of course, the responsibility of the Westminster Parliament; and so the Bill makes specific provision for Wales as well as for England. Indeed, as my forthcoming amendments on Welsh matters will demonstrate, it is taking all of us a little time to work through all the implications of how that operates. The amendments which I shall move are intended to give Wales the tailored provision necessary to those new devolved circumstances.

First, in specific answer to the questions which have been raised, I should say that as a result of the devolution settlement and under the terms of the Government of Wales Act 1998, it is for the National Assembly for Wales to decide how it should organise and fulfil duties such as those to be conferred on it by this Bill.

The National Assembly made the decision that in relation to regulating Part II services, it wishes to undertake those functions itself rather than through a separate care standards commission. It made that decision following a wide-ranging consultation exercise carried out last summer in which two main options were canvassed. The first option was that proposed in the amendment moved by the noble Lord, Lord Clement-Jones; namely, that there should be an independent statutory body to take on the regulatory

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task, similar to the proposal adopted already for England. The second option was for the Assembly to take on those functions itself.

The responses to that consultation gave a two to one majority in favour of the proposal that the Assembly itself should take on the regulatory functions. The National Assembly's all-party Health and Social Services Committee strongly recommended a single all-Wales regulatory body to be set up as part of the Assembly rather than as an independent body.

Following the consultation process and the committee's recommendation, the proposal was agreed by the then First Secretary and it was as a result of that decision that the provisions in the Bill were drafted as they were.

The approach that the Assembly wishes to take provides a different approach for Wales in terms of structures and operational matters but it is entirely consistent with England in terms of the principle, scope and robustness of the regulation. It will be for the National Assembly to make regulations under the terms of the Government of Wales Act to define the detailed arrangements for fulfilling the new regulatory duties. That may involve establishing an executive agency of the Assembly; or the Assembly may prefer to have the regulatory responsibilities carried out within the existing departmental structure. Those decisions are for the Assembly to take.

The current position is that the National Assembly has taken a decision on its preferred approach in that area. The Bill sets out the overall framework for the new regulatory system and the approach in Wales, therefore, is wholly consistent with that of England. But it must be left to the Welsh Assembly to make the decisions in relation to detailed matters and how the functions are to be delivered.

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