Care Bill [Lords]

Baroness Keeley Excerpts

Tuesday 11th March 2014 Commons Chamber

[Dr Sarah Wollaston (Totnes) (Con)]

I love medical data. They have undoubtedly saved my life and the lives of almost everybody in the House. Medical data, particularly big data, allow us to identify which drugs and procedures work and which do not work. They enable us to pick up the rare side effects of medications that have recently been released on to the market before they can wreak the kind of havoc that we have seen in the past. They enable us to identify which are the good hospitals and which are the failing hospitals. They allow us to identify which clinicians need serious retraining and from which clinicians the public need protection.

I would argue that evidence-based medicine is one of the greatest advances of our age. Evidence-based medicine works a lot better if we have access to big data. I state for the record that I do not intend to opt out. I hope that the Government will use the six months that we have to mount a clear campaign to the public that sets out just what the possibilities are.

I also feel that some of the concerns about releasing big data to pharmaceutical companies are misplaced. We need our pharmaceutical companies to be able to access those data, and there is a virtuous circle. We know that if we attract more research to the UK, not only will that benefit our universities, it will create more employment.

[Barbara Keeley (Worsley and Eccles South) (Lab)]

My honourable colleague from the Health Committee mentions pharmaceutical companies. Does she feel it is appropriate—we touched on this in the first part of the debate—that insurance companies have access to hospital data? As I said yesterday, BT now has access to our hospital patient data on the cloud systems in the United States. Does she think that those uses are concerning, and what should we do about them?

[Dr Wollaston]

That is absolutely correct and I will come to those points later in my remarks. The public did not expect to see their records uploaded to insurance companies, specifically where that resulted in higher premiums for many people.

We have a virtuous circle of improving access to data for our universities and creating high-quality jobs within the industry. If we can attract research to this country, and it is carried out among the UK population, the results from that research will be more relevant to the British population. Also, less research will be carried out in circumstances that are ethically questionable or with oversight that may not be up to the standards we expect in this country, or that sometimes exploits people in developing countries and where we cannot be sure of the accuracy and reporting of that research.

This is a virtuous circle, but I am afraid it has unfortunately been broken by the oversight and some of the arrangements that have taken place in NHS England and the Health and Social Care Information Centre. It is frankly beyond me that nobody has assumed responsibility for destroying the trust in what should have been the most exciting advance that would have benefited countless hundreds of thousands of people, not only now but in the future.

On the six-month delay, I call on the Minister to set out clearly how we will campaign to inform the public of the benefits of the proposal, but also of the risks. We have seen a rather patronising approach that has assumed the public will not notice or care about those small risks, but they are there and we must set out clearly what they are and how they will be addressed and minimised. There is much more we can do to minimise those small risks.

Of course we need transparency about past errors; the performance of NHS England and the Health and Social Care Information Centre in the Health Committee was disappointing. I am glad that on its website, NHS England has now clarified that Sir Nick Partridge, former chief executive of the Terrence Higgins Trust, will conduct an audit of all previous data releases by the NHS information centre—the predecessor body. We are also expecting the release on 2 April of all the data released by the current body. I understand that that will set out the legal basis for those releases, but also their purpose, and that goes to the heart of my amendment.

We must have clear penalties for breach, not only in the provisions in the Bill, but across the whole NHS and social care sector. The Minister will know that in practice, if somebody wants to snoop on someone’s personal medical data, there are far easier ways to do it. He will also know that the penalties are derisory. In a well-publicised case in December 2013, a finance manager at a general practice had been deliberately snooping on the records of thousands of patients within the practice, and focusing—rather disturbingly—on one young woman he had gone to school with and her family. Those were repeated breaches of her and her family’s privacy in a really toxic way. That individual was fined only £996. The public need to be clear that there will be severe penalties not only for individuals who deliberately breach privacy, but for companies. A fine of £996 for an insurance company or a large body is laughable.

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[Dr Wollaston]

I agree with my right hon. Friend. Free text takes us into a different territory. People say things in free text to their doctor knowing that it will not appear in a coded form.

There are other ways in which we can improve reassurance for the public. Perhaps we could pseudonymise data before they leave the practice, which would introduce another important layer of protection. That suggestion has been made to the Minister on a number of occasions.

[Barbara Keeley]

The hon. Lady was in the Chamber yesterday when I talked about the cloud systems using NHS patient data launched in the States. What disturbed me about that was that the commercial companies involved said that the data—our patient data that they were using—included clinical data, demographics, education and income. That provided a context, and the companies could link episodes throughout a patient’s life. People would be disturbed if they understood that companies charging for usage in another country had linked their data in that way and had almost a lifetime’s coverage of people’s medical records.

[Dr Wollaston]

Linking primary and secondary care data is so important, but the purpose to which it is put is at the heart of the matter. To whom are the data released? If data are uploaded to Google—27 CDs of our database—and leave the premises, we have no control over them. We could not apply in the States the controls and sanctions I have described. It is simply not good enough to be reassured that the data will not be handled by Google staff. What is to stop them accessing the data when they have gone offshore? The hon. Lady is right to make that important point.

My amendments are about improving the situation in two ways, the first of which is on the purpose of the information. Will the Minister consider adding the word “improving”? He might be concerned that, if the wording is “improving health and adult social care”, the Bill could restrict open research. I do not agree. He will know that improving the care of patients is fundamentally the purpose of research. The amendment would therefore not restrict open research. The amendment would put beyond doubt the fact that the fundamental purpose of releasing data to, for example, insurance companies or Genomics UK, is improving care. People would see that the data release is not for a fundamentally commercial purpose to benefit a commercial organisation without a necessary link to improving care for people in the UK. Those questions should be asked at every stage of the process.

It was reassuring yesterday to hear the Minister clarify that insurance companies will be specifically excluded. However, there is no reassurance in the existing wording in respect of other organisations, including, for example, the Department for Work and Pensions. We can see how the case could be made that disseminating information to the Department for Work and Pensions is for the purposes of

“the provision of health care or adult social care”

or “the promotion of health”, which is the existing wording of new clause 34. As he knows, the longer somebody is off work with, say, lower back pain, the less likely it is that they will ever return to work. The Department for Work and Pensions could argue that disseminating information is all about improving care, but in fact, the fundamental purpose might be altogether different. If the principle in the Bill is that information dissemination is clearly about “improving” care, it would focus people’s minds on the underlying purposes when they make appraisals about whether their information should be given out. That could happen without disadvantaging primary medical research access to the information—the principle of improving care would clearly be at stake. I hope the Minister considers adding the word “improving” to the Bill.

My amendment (b) would mean that there is a reassurance in the Bill on how the data are handled by the person receiving them. We have the reassurance of the confidentiality advisory group, but including a responsibility and a duty in the Bill not just for those giving out the information but for those receiving it would be helpful. I ask anyone following this debate to hold their fire and not to be distracted by those who are rather jumping on the bandwagon on this issue and seeking to undermine the fundamental principles behind care.data. Those principles are important and we could save countless hundreds of thousands of lives in the future by having good access to medical data. But it simply will not do to gloss over the very real concerns that have been expressed. We will see the same problems arising six months down the line unless those very real concerns are addressed. To those who are following the debate, I say, “Do not opt out.” Let us give the Government, NHS England and the Health and Social Care Information Centre the opportunity to address those real concerns and to put them beyond doubt. I will not opt out and I hope that others will join me.

[Barbara Keeley]

In my early career, I worked as a systems programmer and engineer for IBM. I do not usually have much opportunity to mention that, but it is probably appropriate in this debate. I have been struck in recent weeks by how many people with an IT background—as well as those with medical backgrounds—have serious concerns about care.data and the plans of the Health and Social Care Information Centre.

The Minister was not keen to take interventions last night, so I will ask my questions now. I want to touch on the important issue of consent for the uses of patient data. As I said earlier in the debate, the hospital episodes statistics database was originally an administrative database. When did any of us sign up to having our data used to recalculate the cost of insurance cover for long-term illness? Given the points I made about the use of our confidential hospital patient data in commercially chargeable systems in the US, when did we sign up to have our data used on a chargeable basis by companies such as BT and MedRed on their cloud systems in the US? I do not recall doing that, and I suspect no one else does either. Does the Minister agree that patients should have the option of having their data used only for clinical care and for commissioning that care? If the genie is not completely out of the bottle yet, that is a question worth asking.

[Paul Burstow]

The hon. Lady is making important points about the need to be clear about what these data are used for. There is an argument that anonymised and properly controlled data have a part to play in the area of medical research. Does she think that should be out of scope, or can we have safeguards that enable it to be in scope? Understanding whether a medicine works in a particular way with a population is a very powerful use of such data. In her view, is that appropriate or not?

[Barbara Keeley]

In the concerns I am listing, I am not touching on the use of data in medical research. My concern is about the revelations we have had in recent weeks. I am citing commercial uses. Those data are being used on a chargeable basis and the companies involved seem to be crowing about it.

Can a project such as care.data guarantee that what patients sign up to now—or at any point in time—will not mean something different in future months when new datasets are gathered? The hon. Member for Totnes (Dr Wollaston) touched on some of the exciting possibilities for data, but new uses are being planned all the time. I mentioned systems in the US, but the Health Secretary recently signed a memorandum of understanding with the US Health Secretary for secondary uses sharing. The Minister last night said that he would not comment on a US system, but our hospital patient data is on those systems being used on a chargeable basis. Should patients have the right to withdraw their consent if new uses are developed that they do not approve of? The data have gone, and people are developing new uses for them, way beyond what any patient may have felt they consented to.

My right hon. Friend the shadow Health Secretary raised the issue of lack of transparency over the patient’s right to opt out. He asked about the junk mail leaflets— as they have been called—that were not even delivered to every household. What do Ministers propose to do to explain to all patients about the extraction of their identifiable personal data, and what precisely the dissent codes mean? We touched on this in our Health Committee inquiry sessions, and it was not clear, although some people thought they knew. It is a pity that Ministers have not taken the opportunity to answer the questions that were put to them in Health questions—the information changed on the HSCIC database on the very day we had Health questions in the morning.

We know that NHS England and the HSCIC can require GPs to upload patient data in an identifiable form from every GP practice in England, to be linked with the hospital episode statistics and other datasets. That is concerning enough, because it is a powerful new use of a lot of data, but the hon. Lady suggested that the HSCIC is talking about free text. That is a concern, because that is the place where people open up to their doctor and might give information that they do not want to be shared.

It is important that we know exactly how the HSCIC is funded. In the spirit of transparency, will Ministers request full disclosure of all funding sources of the HSCIC, including outside earnings from third parties for the use of data? I have talked about seeing our hospital data now being used on a chargeable basis by companies such as BT in the US. Who pays for the HSCIC’s staff? Are staff seconded to the HSCIC? Who pays the transaction costs? We have seen examples recently of networks of private organisations coming into NHS England to write and fund reports and lead consultations. Who pays for staffing and transaction costs, if it is third parties, is a key aspect of transparency.

The Health Committee has held an initial inquiry into care.data, and I and other Committee members expressed real concerns about the scheme and the impact it could have on the trust between patient and doctor. Our concerns have been compounded by news that commercial companies have been allowed to pay for NHS patient data, and use them for purposes unknown to the public. The use of our data has gone beyond our control, the data are in other countries and uploaded to cloud servers, and we do not know where they are.

[Grahame M. Morris (Easington) (Lab)]

My hon. Friend is making pertinent and relevant points. Does she share my concern about the need to tighten up on section 251 exemptions? They allow the use of identifiable data for commissioning purposes. NHS England was granted a 251 exemption last April, and that may lead to identifiable data being used at a national level, a regional level, in the area teams and in the clinical commissioning groups. Is that something that the Government should address?

[Barbara Keeley]

Indeed it is. There is a question about why CCGs have to have identifiable patient data, and there is a lot of concern about that, which my hon. Friend is right to raise.

We expressed our concerns, but they have been compounded by reports of use of data unknown to the public. The Minister was unwilling to answer the point I wanted to put to him earlier in the debate about how the HSCIC will treat organisations such as BUPA, which are insurance providers as well as providers of health and care. I hope that he will answer that question when he winds up the debate. BUPA is one example, but there are other companies that have multiple functions—some of them are straightforwardly commercial and others involve health and social care—and there is scope for confusion if those firms apply for and obtain access to the data.

The revelations we have already had show that HSCIC does not have accountability, transparency or sufficient control over releases of patient data. In our Committee inquiry, it was put to HSCIC and to NHS England that one of the ways being recommended to ensure that escapes of patient data did not happen, and to allay the fears and concerns we have expressed, was for HSCIC to run on the basis that it kept the database intact and did not download datasets outside the information centre. What it did was take in research queries and ran them. That would be much safer and that is what is done on secure systems in other places. A mechanism has been suggested and I hope it is being considered.

I appreciate the comments made by my colleague, the hon. Member for Totnes about not opting out, but a recent survey of 400 GPs found that 40% intend to opt out of the scheme because of a lack of confidence in how the data will be shared.

[Dr Wollaston]

Does the hon. Lady agree that we have an opportunity, in the next six months, to provide reassurance on some of these real concerns? Does she share my hope that GPs will change their position and that we should be doing everything we can, as opinion-formers, to encourage them to do so?

[Barbara Keeley]

I would like to think so, but I am not going to hold my breath. I think I am a lot more pessimistic than the hon. Lady. Indeed, we know that some GPs have been so alarmed that they want to opt their patients out of the scheme. They should be able to do that without penalty. It is up to Ministers, NHS England and HSCIC to rebuild that confidence, but they are not doing so at the moment. They seem to see what is going wrong as a communication or public relations problem. It is not a communication or PR problem; it is a very serious problem with regard to the integrity of what they are doing, and a lack of transparency and accountability. We cannot say that enough times.

[Sarah Newton (Truro and Falmouth) (Con)]

I have worked alongside the hon. Lady to try to improve our social care system, so does she not agree that it is important that we work on this issue so that GPs are confident about sharing data? Otherwise, how will we enable the integration of social care with the NHS in the community to give people the sort of care that I know that she and I, through all our work together in Parliament, want to see?

[Barbara Keeley]

Yes, indeed, but I cannot emphasise enough that I do not feel much confidence at the moment and I do not blame GPs for not being confident. They are, in data protection terms, the owners of their patient data. If they do not feel that their concerns have been allayed, we have some way to go. I will touch on that point in a moment.

There are fundamental concerns on how data will be shared and the Government’s amendments do not address them. The amendments would improve Government new clause 34, but broadly it offers no further protection. It seems that data could still be released to commercial bodies, such as private health care companies that are also health insurers, the pharmaceutical industry and private health care providers. We need assurances on that. As far as I can see in this debate, we have not had them.

The Government’s new clause will actually widen the dissemination of information to include the promotion of health. Promotion of health can take in all kinds of commercial companies, for example food and drink companies that say they have a public health campaign. This will cause more problems. It draws the purposes so widely that misuses would still be permitted, and even be given a statutory basis. The requirement that the HSCIC must have regard to the advice of the confidentiality advisory group is still an inadequate protection.

I have added my name to amendments (a) and (b), tabled by the hon. Member for Totnes, because they would narrow the purposes for which data can be disseminated. However, I remain concerned about the commercial exploitation of patient data. I support new clause 25, which highlights the seriousness of the offence of misusing patient data. We need a clear disincentive for institutional abuse of confidential patient data with appropriate penalties including, as the hon. Lady said, imprisonment. Imprisonment is appropriate for the abuse of confidential patient data.

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[Jim Shannon (Strangford) (DUP)]

I was under the illusion that there would be five speakers ahead of me, but I am none the less pleased to make some comments on amendments (a) and (b) to Government new clause 34, and on new clause 25. I thank the hon. Member for Totnes (Dr Wollaston) for setting the scene, and the hon. Member for Worsley and Eccles South (Barbara Keeley) for her contribution.

My inbox, like many others, has been full with messages from various charities on different aspects of the Bill. Having sat on the Care Public Bill Committee, I can well understand many of their concerns. I received a briefing from Cancer Research UK, as many other Members did. It was informative and clear, and raised points that I do not believe have been addressed in the Bill and require greater clarity through amendment.

Along with Cancer Research UK, I warmly welcome the clauses that will introduce the Health Research Authority as a non-departmental government body. I have the highest respect for the Minister, but last night clarity on this was sought by the shadow Secretary of State, the right hon. Member for Leigh (Andy Burnham), the hon. Members for Easington (Grahame M. Morris) and for Worsley and Eccles South (Barbara Keeley) and me. With respect, I do not think that Hansard gives the clarification that right hon. and hon. Members, Cancer Research UK and Macmillan are seeking. I am hopeful that the Minister will today be able to give us that assurance and clarity.

Clarification of the amendment of section 261 of the Health and Social Care Act 2012 is needed to ensure that access to data for research is not restricted on the basis of the amendment. Cancer Research UK states:

“While we appreciate the context of this amendment and understand that the motive behind it is to avoid inappropriate disclosures of data, we are concerned that the wording of this is unclear. We would like reassurance that access to data for researchers is included under ‘provision of health care and adult social care’ and that access to research data will not be restricted on the basis of this amendment.”

I hope the Minister will be able to provide assurance on that.

Cancer Research UK is one of the largest funders of clinical research in the United Kingdom of Great Britain and Northern Ireland. It is currently running more than 240 clinical trials, which in 2012 recruited some 37,000 patients. Clinical research is important to find drugs that work and treatment that saves lives. Today in Westminster Hall, we were made aware that with better access to new cancer drugs, 5,000 more people would be alive today and that many more lives could be saved. It is essential that we develop an understanding of both new and existing treatments, and that they are offered through the NHS. We therefore want to see a regulation and governance system in the NHS that promotes and supports research, while also protecting patients.

There has been significant controversy surrounding the proposed care data upload of GP records to the Health and Social Care Information Centre and there have been at least two debates in Westminster Hall on these issues where Members have expressed their concerns strongly. Concerns have been expressed that the public have been insufficiently informed about this upload and that data may be released inappropriately, for example to insurance or marketing companies. I know the Minister replied last night to my intervention, but the doubt lingers even today within Cancer Research UK, Macmillan Care and other charities that had expressed initial concerns. I have concerns regarding the nature of the release, but it was never my intention to restrict data going to the likes of Macmillan or Cancer Research UK to aid in their fight against the scourge of cancer.

[Barbara Keeley]

I read a blog article this morning written from the point of view of people with disabilities who had real concerns about the mention of insurance providers. It is often very difficult for people with serious conditions to get insurance, even travel insurance, and the notion that their medical data are being linked to insurance information, or might be sold in future to companies that are insurance providers—even if those are health and social care providers—is a real worry for them. They are really fearful about this and I think we would see a mass opt-out by people who have that fear.

[Jim Shannon]

That is the issue, summed up in a couple of sentences. The Minister may look to his civil servants for some direction; he may have it already. If so, that is good news.

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[Sarah Newton]

The hon. Gentleman has given yet another reason for the importance of collecting and sharing data in a way that helps to improve health outcomes. A further example is an inquiry into medical implants that was conducted by the Science and Technology Committee. Orthopaedic surgeons were able to keep a great many data relating to the types of implants used in, for instance, hip replacements, and to track, over time, the outcomes for the patients. As a result of that research, they were able to identify particularly problematic implants, and the information was shared among clinicians so that they could improve existing implants and develop new ones. Hip replacements have improved greatly as a result. It is vital that we establish frameworks that give confidence to patients and to medical practitioners, so that such information can be collected and used to improve patient outcomes.

[Barbara Keeley]

The hon. Lady clearly supports such uses of the databases, but, as I said earlier, there is concern about the fact that this is going global. There are memorandums of understanding between countries, and the granting of access to one organisation seems to lead to its being granted to others. The whole thing could easily spiral out of control. Does the hon. Lady share that concern? I do not know whether her inquiry established any way of describing the system that would enable people to understand it and have confidence in it.

[Sarah Newton]

In many of our inquiries, we have looked into international collaborations between universities that are tackling some of the greatest challenges of our time. One example is research into various forms of dementia, and proteins in the brain that contribute not only to vascular dementia, but even to vCJD. We have concluded that in order to meet the huge challenges that those diseases pose to the whole world, we need to pool our resources across universities and research communities internationally. There is an increasing number of well-established protocols and sensible ways of reassuring patients and others about the use of their data. Such international collaboration makes it more likely that we can make discoveries that will drive improvements in people’s outcomes.

Frameworks and safeguards exist to enable universities and academics to collaborate. We should be careful about the language that we use in this context, because there has been scaremongering, and people are identifying all sorts of potential uses for the data for which there is not much evidence. We have been reassured several times today that the information would not fall into the hands of insurance companies and be used in a harmful way.

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[Mr Stephen Dorrell (Charnwood) (Con)]

Mr Speaker, I take your rap across the knuckles in the spirit in which it was intended. I apologise to the House for being late today, due to a diary conflict. I hope I can claim that I do not arrive, speak and then disappear very often. My practice is to be here for a debate and to contribute and listen to it, and I apologise to the House for not matching that standard in this debate.

I am, however, grateful for the opportunity to speak in this debate, because a discussion about the way in which the health service handles data and introduces a culture that allows a freer exchange of data around the health and care system is fundamental to the delivery of more joined-up services—ultimately between the NHS and the social care sector—which is an objective that is espoused widely, and regularly repeated, in this House.

The Select Committee had a session at which NHS England gave evidence about the position it got to with care.data and the delay that was announced two or three weeks ago. Although there is a widespread view within the Select Committee that it is important to get better at handling data in order to allow the delivery of improved services, we also had a sense that NHS England, in its handling of the care.data programme, had not respected sufficiently the sensitivities both of individual GPs, as the hon. Member for Easington (Grahame M. Morris) was saying, and—more importantly, ultimately—of individual patients about the safeguards that apply to their data and the uses to which those data can be put.

I agree with the hon. Gentleman that it is important that the six months of additional breathing space NHS England has given itself is used to address those concerns, both within the service and among patient groups, about security of data and the safeguards in respect of which data are used as a result of a more open—in the correct sense of that word—use of data around the system.

[Barbara Keeley]

As the right hon. Gentleman was not here at the time, he will not know that I moved a manuscript amendment on better parliamentary oversight of the Health and Social Care Information Centre. It seemed to me—I wonder if he noticed this, too, in our Committee inquiry—that there were a great many individuals making decisions on key issues. Questions were put to the HSCIC about the pseudonymisation of data at source, yet the answer we got back was, “Well, I’ve looked at that, and I don’t support it.” The comments were all a bit “I”, but I would like a bit more of the “We” in oversight, and not so much of the “I”.

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[Mr Dorrell]

First, we must concentrate the rationale for the programme on to patients. Looking back at how NHS England has got itself into this position over the past few weeks and months, I have lost count of the number of times I have been told how important the programme is for research. I absolutely agree that it is important for research, but the health and care system does not exist to support research; it exists to treat and care for patients. The logic of allowing commissioners to develop joined-up services that respond to individual people’s needs—and the pattern of need based on multi-morbidity to which the right hon. Member for Sutton and Cheam (Paul Burstow) has referred—must be placed centre stage in the justification for the improved handling of data in the health and care system.

I go back to the point that this must be about treating people, not conditions. We cannot achieve that if we do not have the information to allow us to connect up the experience of the patient between one part of the system and another. In regard to the logic behind NHS England’s plans, yes there is a research argument, but—with apologies to the research scientists—it is a secondary argument. The primary argument is that we must improve the services delivered to patients and service users.

[Barbara Keeley]

The hon. Member for Oxford West and Abingdon (Nicola Blackwood) has just mentioned the need to reassure patients; that is a big concern at the moment. I have here the transcript of the information I was given in the Health Committee, in which Max Jones of the HSCIC said of the care.data programme that the GP extraction services

“took great care to make sure that we only extract the coded information in those records and not the free text notes”.

However, the hon. Member for Totnes (Dr Wollaston) said earlier that there had been discussions in HSCIC meetings about extracting free text data. Is the right hon. Gentleman as alarmed as I was to hear that? Does he agree that, in the light of the need for reassurance, we do not need such revelations, news and other bits and pieces coming at us from every direction every day to make the whole fiasco worse?

[Mr Dorrell]

I am not going to comment on whether the free text data should or should not be part of the system, or on whether the safeguards are adequate. However, I agree with the hon. Lady absolutely that the one sure way of undermining public confidence in safeguards is to change those safeguards every five minutes according to whichever witness we are listening to.

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Trust was damaged further when the Secretary of State claimed, incorrectly, that every house in the country had received a leaflet on care.data, informing them of the project, its purpose and how individuals could opt out if they wanted to. That is not true. A freedom of information request has revealed that NHS England did not ask for the leaflet to be classified as in “in exceptional circumstances”, so the leaflet has not been delivered to households registered with the Royal Mail’s door-to-door opt-out.

[Barbara Keeley]

My hon. Friend is making a good speech and laying out the issues clearly—he is talking about the junk mail leaflet that was not delivered to every household. It also did not have an opt-out form. As a member of the Health Committee, however, I am still getting queries from people who fear that even after opt-out data will still leave their GP practice to be used by HSCIC. Do we need to be assured about that as well?

[Mr Reed]

Absolutely. That is one of the real issues. As we have heard from Members on both sides of the House, absolute clarity is needed on such issues and on the data, which we as individuals own, from those who seek to provide that data to other people for other purposes. This goes to the heart of the matter, and the fundamental issue—that fundamental breach—is one of trust. My hon. Friend is absolutely right to raise that.

Trust can never be given with blind faith, but it can be built if it is based on accountability. That is what new clause 25 and amendment 29 seek to achieve. The new clause seeks to create a new, specific offence of the misuse of data provided by the HSCIC. Building on the schedule of offences in the Data Protection Act 1998, it makes it an offence to use data provided by the HSCIC for the purposes of re-identification. A person or organisation found guilty of that offence would be subject to an unlimited fine. In addition, it makes it a requirement for any organisation making applications for data from the HSCIC to disclose any previous convictions under the offence.

The purpose of the new clause is to help build public confidence in how individual patient data are used by ensuring that any person or entity who misuses the data is liable to significant criminal sanctions. Patients can then be assured that their privacy and the proper use of their medical data are of the utmost importance to Parliament, the judiciary and the NHS. The new clause would also place a duty on those convicted of misusing data to declare that conviction when reapplying for future data. In reality, barring some unforeseeable public interest, those guilty of misusing data once would be unlikely to gain access again.

In order to ensure a robust system, accountability for the use of the data must also cover those who grant permission for the data to be used. Clause 116 removes from the Secretary of State the duty to approve applications to use patient data for medical research. That is wholly and entirely wrong, and amendment 29 seeks to restore that duty.

In light of the letter from the Chair of the Health Committee to the Health Secretary, the emerging details of how patient data have been used and the rather strange pronouncement from the HSCIC that it will not say more about improper release of medical records until “later in the year”, the Secretary of State’s accountability for how patient data are used is absolutely critical. The use of patient data is a matter of huge import, and the issues surrounding it are enormous, too.

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[Dr Poulter]

Of course strict criteria are in place under the 2012 Act about the use of data where a patient could be identified. The Health and Social Care Information Centre cannot randomly release data that would identify patients, except where there are specific public policy reasons for doing so, such as in the event of a flu pandemic or a public emergency. There are strong safeguards in place under that legislation to protect patient data. It would be wrong of the hon. Gentleman—I know he often inadvertently misleads himself in some of his conclusions and goes around in circles in his remarks—to confuse Members and to confuse the House. The legislation is clear. He has been in many debates on the matter over the past few weeks, and strong protections are in place to protect patient confidentiality and to prevent patients from being inappropriately identified.

I do not want to be drawn into individual cases, but the hon. Member for Worsley and Eccles South also raised the issue of the MedRed BT Health Cloud, which will provide public access in the United States to 50 million de-identified patient records from the Health and Social Care Information Centre in the UK. We have clarified the matter. The data referred to are not confidential, but are published anonymous data of the aggregate population—not at patient level. The data are available freely to any member of the public or organisation via data.gov.uk. There is no conspiracy about the data; they are freely available to any one of us in this Chamber or to any member of the public.

It is worth highlighting the powers of the Secretary of State, which the shadow Minister also raised in his comments. Let me reassure the hon. Member for Worsley and Eccles South in respect of the amendment that she has tabled today. Section 245 of the 2012 Act enables the Secretary of State to direct the Health and Social Care Information Centre to establish information systems—to collect data—including systems on how to carry out that collection.

The Secretary of State can also direct the Health and Social Care Information Centre to report on any matter about its functions. If concerns were raised about the issue of free text data, which my hon. Friend the Member for Totnes mentioned, the Secretary of State could pass on directions to the Health and Social Care Information Centre.

[Barbara Keeley]

The Minister referred to my manuscript amendment on parliamentary oversight of the actions of the HSCIC. I tabled that amendment late because there is a belief that the Secretary of State and the Minister have not been asking the right questions. It has taken the Health Committee and other Members making inquiries to bring out all the issues. We need to keep on doing that, which is why I tabled that important amendment. There was not time to do it in a timely way, but that is why it was done.

[Dr Poulter]

As a Member of the previous Government, it is a pity that the hon. Lady did not take these issues more seriously at the time. It has been left to the current Government to fix the problem through the 2012 Act and the amendments that we have tabled today. That is not good enough and she knows it. It is also the case that she has not read the 2012 Act properly, because I have just outlined the section 245 powers that the Secretary of State has. That is parliamentary oversight in anyone’s terms.

Finally, let me turn to amendment 29 tabled by the hon. Member for Copeland (Mr Reed). As he has said:

“The importance of such data in medical research, and in the synthesis of new treatments and better care, cannot be overstated. In research terms, more information about how people with certain conditions react to treatments can led to better research being undertaken, which uses resources more efficiently and improves a patient’s quality of life.” ––[Official Report, Care [Lords] Public Bill Committee, 30 January 2014; c. 513.]

I completely agree with that. It is important that we uphold a person’s right to confidentiality while enabling the use of information to improve the current and future health and care of the population, with appropriate safeguards to protect confidentiality.

The Health Service (Control of Patient Information) Regulations 2002 made under section 251 of the National Health Service Act 2006 modify the common law obligations of confidentiality. It allows researchers, public health staff and other medical practitioners to access information where there is no reasonably practicable way of obtaining consent to use such information for the purposes of medical research. That is in the interests of improving patient care or in the public interest.

Amendment 29 requires the Secretary State to give approval for the processing of confidential patient information for research purposes. In January 2011, the Academy of Medical Sciences published a review of the regulation and governance of health research. It criticised the complexity of the arrangements for regulating the use of patient information, saying that they are a significant barrier to research. None of us in this House wishes to put barriers in the way of medical research. The Secretary of State has already delegated the function of the approval of processing confidential patient information for research purposes to the existing Health Research Authority special health authority. The 2002 regulations as amended by this Bill would give the new HRA this function directly.

Under this Bill, the HRA would be responsible for overseeing the ethical review of health and adult social care research. As access to patient information may involve the consideration of ethical issues, it makes sense for the HRA to make decisions on applications for access to confidential patient information for research purposes.

Robust legislative safeguards ensure approval for access to patient information for research purposes is given appropriately by the HRA. These include a condition that the HRA may approve processing of patient information for research purposes only if approval has been given by a research ethics committee, established or recognised by the HRA, and a requirement that the new HRA appoints an independent committee to provide advice on applications to process patient information. This provides continuity for the committee known as the confidentiality advisory group, which I spoke about earlier in my opening remarks.

--- Later in debate ---

[Andy Burnham]

If the Minister gave councils budgets that enabled them to be more generous, they might have a chance, but drastic cuts mean that they cannot provide care that is worthy of the name. He will know of the fears of organisations that represent disabled adults of working age. The Royal National Institute of Blind People, for instance, fears that the move to retrench eligibility criteria to cover only substantial and critical needs will remove care from people with moderate needs whose support currently enables them to continue to work.

[Barbara Keeley]

I understand that the Minister is to visit Salford tomorrow. Perhaps he would like to talk to Salford city council, whose budget has been cut by £100 million over the last three years, about how it might be more generous. I am glad that my right hon. Friend has mentioned carers and their new rights, but how hollow do those new rights seem to carers in Salford, given that 1,000 people will lose their care packages this year and 400 will not qualify for them? That is a direct result of what the Government have done.