Care Bill [Lords]

Sarah Wollaston Excerpts

Tuesday 11th March 2014 Commons Chamber

[Mr Speaker]

I remind the House that with this we are discussing the following:

Amendment (a) to Government new clause 34, in subsection (3), after ‘of’, insert ‘improving’.

Amendment (b) to Government new clause 34, in subsection (3), after ‘adult social care’, insert

‘; and if it has satisfied itself that the recipient is competent to handle the data in compliance with all statutory duties and to respect and promote the privacy of recipients of health services and adult social care.”.’.

New clause 25—Misuse of data provided by the Health and Social Care Information Centre: offence—

‘(1) A person or entity commits an offence if they misuse, or negligently allow the misuse of information they have requested and received from the Health and Social Care Information Centre.

(2) “Misuse” means—

(a) using information in a way that violates the agreement with the Health and Social Care Information Centre;

(b) using information in a way that does not violate the agreement with the Health and Social Care Information Centre, but that gives rise to use that is outside the agreed limits of use; or

(c) using information supplied by the Health and Social Care Information Centre in such a way as to allow or enable individual patients to be identified by a third party.

(3) A person who is guilty of an offence under subsection (1) is liable—

(a) on summary conviction, to an unlimited fine;

(b) on conviction on indictment, to imprisonment for not more than two years or a fine, or both.

(4) An entity who is guilty of an offence under subsection (1)—

(a) is liable to an unlimited fine; and

(b) must disclose the conviction on all future applications to access data from the Health and Social Care Information Centre.’.

Government amendment 8.

Amendment 29, in clause 116, page 100, line 29, after ‘Authority’, insert

‘and the Secretary of State’.

Government amendments 17, 18, 15 and 16.

[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.

[Mr Jamie Reed (Copeland) (Lab)]

The hon. Lady makes an excellent case. The maximum fine for an individual breaching the data clause in the situation she describes is £5,000. Does she agree that that is not adequate?

--- Later in debate ---

[Dr Wollaston]

I thank the shadow Minister for making the point that £5,000 is woefully inadequate. The financial penalties—significant ones on a sliding scale commensurate with the wealth of the individuals or organisations concerned—should be set out, but I believe that people should go to prison for such data breaches. Organisations should be clearly held accountable. It should be made clear to them that, should such breaches occur, requests from them will not be looked on favourably. There should be a clear penalty. Currently, those penalties simply do not exist.

How do we explain to the public the small risks and how we will address them? One significant risk has not been covered: the powers of NHS England to direct the Health and Social Care Information Centre to collect information when it is considered “necessary or expedient”. That could include full identifiable, confidential data. Will the Minister address one point on that? I have been told that NHS England has, in meetings with senior researchers, discussed the fact that, in the next releases of care data, it plans to include free text. Free text takes us into an altogether different area, so will the Minister give categorical reassurances on it? I support the principle of a default opt-in, but might not support it if the data included free text. Free text is deeply and intensely personal data and is not coded, and the public need specific reassurances on it.

[Paul Burstow (Sutton and Cheam) (LD)]

Given that the intention, as I understand it, is to create wholly anonymised data, surely the use of that contextual information creates the possibility of re-linking to an individual’s identity. The hon. Lady is right to make that point, and I hope the Minister can reassure us, but surely that is a step too far.

[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.

--- Later in debate ---

[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.

--- Later in debate ---

[Jim Shannon]

Earlier I referred to Macmillan and to Cancer Research UK who, even today, are not convinced. We make these points on behalf of our constituents and the groups that lobby us.

[Dr Wollaston]

Does the hon. Gentleman agree with many commentators, including the British Medical Association, that it would help if the remit of the confidentiality advisory group could be extended from currently just looking at patient-identifiable data to looking at pseudonymised data or potentially identifiable data? That would give further reassurance that there is more oversight so that we do not see the kind of instances that many people are expressing concerns about.

[Jim Shannon]

The hon. Lady is right that the amendments would go a long way to addressing that issue. I hope that the Government take that on board.

In response to the fears expressed by many, several amendments were tabled to clarify the circumstances in which the Health and Social Care Information Centre will be able to release data. We need further clarification of the provisions concerning the dissemination of information, which suggest that the information centre may disseminate it only if it considers that doing so would be for the purposes of the provision of health care and adult social care. Clarification is needed for those charities that have contacted many of us in the Chamber. Cancer Research UK, among other worthy causes, would like reassurance that access to data for research is included on the

“provision of health care and adult social care”

and that access to research data will not be restricted on the basis of the amendment. That is the reason I support the proposals.

Cancer Research UK has said that it particularly welcomes the Government’s inclusion of proposals that would give the Health Research Authority the ability to accept guidance on how the governance of particular research should be handled by the NHS trusts and their duty to adhere to it. These proposals were added following calls from Cancer Research UK and the medical research sector, and were supported by many parliamentarians during the pre-legislative scrutiny of the Bill of which I, with others, was a part.

Governance continues to be the primary barrier to conducting research in the NHS. A single trial can take place across multiple trusts, so obtaining governance approvals from each participating trust, which may have different approval criteria and often duplicate checks, can cause significant delays. New clause 25 would put in the Bill the firmness, accountability and legislative control that is necessary to ensure that the leakage, for want of a better word, of information does not take place. It is important that we do that.

In conclusion, statistics indicate that by 2020 one in two people will get cancer. We had a debate in Westminster Hall this morning on cancer care; it was passionate and well thought out by many Members with personal experience of cancer in their families and their constituencies. The enormity of cancer and what it will do to society is why we have a responsibility in the House to ensure that we help. The need for research and new treatments for cancer is greater now than ever. We must ensure that while protecting people from the unsafe or mercenary use of personal information, we are not hampering the fantastic work done by these charities to discover more about cancer and to help more people win their personal battle. I support these amendments and I ask the House to do the same.

[Sarah Newton]

It is a great honour to follow the hon. Member for Strangford (Jim Shannon), who touched on an incredibly important point: we must not forget the people whose lives have already been transformed by research organisations’ access to data to find cures and prevention for diseases such as cancer. There cannot be anyone in the House who has not been touched by cancer, personally or within their families. It is incumbent on us all to do everything we can to create the right ecosystem and regulatory environment to enable research that will have a life-saving and transformative effect for people.

[Dr Wollaston]

Does my hon. Friend agree that early diagnosis is one the keys to improving cancer outcomes? By linking GP records to hospital records we can identify which practices were not referring early enough and help to improve that practice.

[Sarah Newton]

That is a very important point. Without the sharing of data, such patterns would not occur and we would have the much-talked-about postcode lottery whereby someone’s ability to get timed referrals and access to the best quality care depends on where they live and who their GP is.

I have the great pleasure and privilege of serving on the Science and Technology Committee. We have recently undertaken an inquiry into the regulatory framework for research into all sorts of diseases, including cancer. A very important finding of the inquiry was the essential role of sharing data. It is incredibly important that we come up with the right structures and protections to enable people, and GPs, to have confidence to enable the sharing of that data.

We should be very proud—we in the Chamber must not forget—of the fact that the UK leads the way in many areas of medical research; our universities, our trusts and our foundations are world leaders in what they do. That is very important in terms of our universities’ standing and important to a lot of high-quality jobs in our economy, not only for the benefit of citizens here but people all over the world. We must to do all in our power to maintain a system that enables money to be invested in research at our universities.

--- Later in debate ---

[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.

[Dr Wollaston]

My right hon. Friend made the point that the programme is for the benefit of patients. Does he agree that it would reassure people if we made it crystal clear that it was about improving care and not about systems?

[Mr Dorrell]

My hon. Friend is right, as she always is on these issues. This is about improving the care that is delivered to patients.

Getting away from the debate about data, I want to make my final point. We are repeatedly told that the system is too fragmented and has not taken advantage of the opportunities created by the proper gathering and manipulation of data—as other sectors of the economy have done—in order to reshape services around the needs of consumers. That is the opportunity that the proper handling of data provides, and it is hugely in the interests of patients that we ensure that we take that opportunity. We must take it, but we must do so with proper safeguards.

--- Later in debate ---

[Dr Poulter]

As the hon. Gentleman will be aware, under the 2012 Act, NHS England has responsibility for much of the operational day-to-day performance of the NHS, and NHS England has accepted responsibility for the fact that it did not communicate some of the information about care.data in the best way. But I hope that by referring the House to the safeguards we have in the 2012 Act and the additional safeguards we are putting in place through our Government amendments, we can reassure hon. Members that data will be used for the benefit of the health and care system, and for the promotion of health.

I wish now to deal with some of the good points raised in the debate and I hope to bring further reassurance to hon. Members. My hon. Friend the Member for Totnes (Dr Wollaston) rightly asked about an issue that came up recently in the Health Committee: whether data would be allowed to be passed on to the Department for Work and Pensions. The overriding purpose of any release to the DWP could not conceivably be the provision of health care or adult social care in England or the promotion of health so, no, that could not happen under the 2012 Act or under the provisions we have introduced today.

My hon. Friend also raised issues relating to the HSCIC and free text. As the hon. Member for Worsley and Eccles South (Barbara Keeley) said, it was outlined in the Health Committee evidence sessions that the use of free text had been examined and had, in effect, been ruled out—I hope that my recollection is correct on that. To give further reassurance, may I say that the HSCIC made it clear that the General Practice Extraction Service that we have in place to support the extraction of the data from those GP systems for care.data has taken great care to ensure that we extract only the coded information in those records, not the free text notes, which patients may well have shared during consultations with their GPs? In addition, a number of explicit conditions were excluded from those extractions, including issues relating to HIV/AIDS; sexually transmitted infections; termination of pregnancy; in vitro fertilisation treatment; complaints; convictions; imprisonment; and abuse by others. Clear safeguards and reassurances have been established on those issues, and I hope that reassures my hon. Friend further.

[Dr Wollaston]

Will the Minister confirm that there is no way that free text will be uploaded, either now or in the future?

[Dr Poulter]

As things stand at the moment, free text is not going to be used. That is the reassurance given by the HSCIC; it clearly does not envisage that text being used and it has given reassurances on that. That is reassuring for me and I hope it is reassuring to my hon. Friend. There are those additional safeguards in place, particularly for vulnerable patient groups, to make sure that more personal data about convictions, imprisonment and abuse by others will not be collected by the information centre.

--- Later in debate ---

[Mr Speaker]

Order. I was going to call the hon. Member for Totnes (Dr Wollaston), as she had applied to speak in the Third Reading debate, but if she does not wish to speak, I will call the right hon. Member for Charnwood (Mr Dorrell) instead. Does the hon. Lady wish to catch my eye?

[Dr Wollaston]

indicated assent.

[Mr Speaker]

I call Dr Sarah Wollaston.

[Dr Wollaston]

Thank you, Mr Speaker.

I congratulate the Secretary of State on this groundbreaking Bill. It is disappointing that there has been such a curmudgeonly response to it. Some important concessions and improvements to the Bill have been made during its passage through the House, and it has been a great pleasure to serve on it throughout the entire process, starting with the Committee on the draft Bill. At every stage, the Government have listened to the concerns and made improvements.

There is just one small element that I would like to draw to the Secretary of State’s attention. There has been a step change on the issue of open data. For the first time, there has been recognition of the need not only to publish data but to disseminate the findings of the research involved. That has been an important concession in relation to part 3 of the Bill. We have also heard today about the improvements to the clauses on care.data, and I would like to ask anyone following the debate on that subject to bear in mind that their health, and the health of their children and families, will be improved if we see a commitment to improving access to health data. Let us keep that in focus. We must ensure that we listen to the very real concerns that are being expressed, but please do not opt out of care.data. Let us move forward with this exciting project and with the commitment to research that we have seen throughout the passage of the Bill.