Oral evidence: Handling of NHS patient data, HC 952Wednesday 21 January 2015

Oral evidence, 21 January 2015.

Witnesses

Sam Smith, medConfidential, Nicola Perrin, Wellcome Trust, and Professor Nigel Mathers, Honorary Secretary, Royal College of General Practitioners, gave evidence.

Chair

Good afternoon. Thank you for attending, particularly at short notice. We are very grateful to you. Perhaps you could start by introducing yourselves to those following the debate from outside the room.

Sam Smith

I am Sam Smith from medConfidential.

Professor Mathers

I am Nigel Mathers. I am a GP from Sheffield and honorary secretary of the Royal College of General Practitioners.

Nicola Perrin

I am Nicola Perrin, head of policy at the Wellcome Trust. For this purpose, I also serve on the care.data advisory group—

Chair

The acoustics in this room are rather poor, so you might need to lean forward slightly so that everyone can hear you properly. For those following us who perhaps are not familiar with the detailed background, could you start by giving us an overview of where you think we are now with care.data and the key issues we need to tease out to make sure we do not miss any of those this afternoon? As you know, the focus today will be on pathfinders, but could you give us an overview of where we are now and the outstanding issues that need to be resolved, starting perhaps with Mr Smith?

Sam Smith

To cover the five lowlights which are mainly within the remit of NHS England, for those who opted out after the “junk mail” leaflet that went out a year ago, what do patients, NHS England and HSCIC think the people have been opting out of? What about opt-outs from hospital episode statistics, which have caused so much concern? Has that opt-out been implemented? What will be different for the pathfinders, and what will happen beyond the pathfinders? For the pathfinders, NHS England have said they will send everybody a letter. We have not seen any change in that for several months. Three questions remain substantively unanswered, which we first asked the Committee back in February. What will patients be told? Who will ensure that this is true? How can those things change? All the questions we have arise from hiding the interactions between those three questions. What exactly the opt-out will do is an unanswered question that is key to a lot of those things. The first draft of the CAG regulations we have seen does not define “promotion of health”. Along with the HSCIC’s new data-sharing agreements, which permit commercial reuse to carry on, it was nice to agree with Tim Kelsey that drafting the regulations for CAG in a panic, after a seven-month pause, was possibly unwise. From last summer, NHS England’s commitment to publish the minutes from the care.data programme board, where all the care.data pathfinder decisions are made, is entirely unmet. I understand there is a hold-up somewhere in NHS England, but I do not know what it is. Finally, Dame Fiona’s care.data report has a long list of unanswered questions, which we agree must be answered before any pathfinders proceed, and the 2014 annual report from the IIGOP provided case studies of what goes wrong when information governance and data sharing is not handled properly.

Professor Mathers

Our original concerns about care.data, which we raised last February, were primarily about ensuring that the NHS was beyond reproach in its use of patient data. Our work has been concerned with ensuring that that is indeed the case. That is what underpins our concerns. The first concern we had last February, which I think is being addressed within the pathfinder, was that people need to know what they were opting out of. There needs to be information. I know there is a facility within the pathfinder project to ensure that all patients over 15¾, I think, will receive information about whether or not they can opt out, what care.data is and so on. Therefore, that is one issue that is being properly addressed within the pathfinder project. The other issue that we raised at the time was to do with hard-to-reach groups who might not be able to understand the communication in the form it was delivered. I know that is also being addressed within the pathfinder group. We also had concerns about what the data would be used for, and there has been a full and comprehensive explanation of that. I know that the legislation has been adjusted to address the use of the data, particularly for commercial purposes. The current position, as we understand it, is that data cannot be used for profit—it is just to cover costs—and it does not go to insurance companies. The two concerns that remain are that the whole thing has now become so complicated that, quite frankly, it is very difficult for any one person to understand all the bits of it. A whole range of committees has been formed—I have six on my list here—all of which have some form of scrutiny or oversight of the process. One concern would be to ensure that all those groups work together, have good communication and make sure there is no overlap between them, and that at some point in the future there is a report as to whether this alphabet soup of organisations is functioning properly and efficiently. The other matter is a plea to get the pathfinder phase right. This is the last chance saloon for care.data. We should not rush it; we need to do it properly. I do think that given the way it has been set out it is being done properly, but we must not rush it. We must do it steadily, in conjunction with patients and all other interested parties, to make sure that GPs and people whose records are going to be used are on board. We must take that slowly, steadily and systematically, as we have done, but with the proviso that we do not make it any more complicated than it currently is.

Nicola Perrin

I would agree with all of that. We have come a long way from where we were at this time last year. At that point, we were calling for much clearer communications about the potential benefits but also the risks and safeguards in place. We also wanted much clearer governance arrangements and clarity over those safeguards. The work that has gone into the communication strategy has been very helpful and impressive over the last year. There has been an extremely good engagement and dialogue exercise, and the latest draft of the communication for the pathfinder practices is a significant improvement on last year. We still have some questions and outstanding concerns about the governance arrangements and the safeguards, in particular to make sure that who can and cannot access data and for what purposes is very clearly defined. We are looking to see that in the confidentiality advisory group regulations that Sam mentioned. I think it would be helpful to discuss those in more detail in this Committee session. We also have some questions about the proposed mechanisms for access to the secure data facility proposed for the pathfinders. It may work fine for the pathfinders, but it is not scalable and proportionate for access beyond that, so we must take into account what needs to be achieved in the longer term, if there is to be a national roll-out. As Sam said, clarity over the opt‑out is still important.

Chair

I am going to turn to Andrew. If, when we get to the end of the session, you feel you have not had a chance to make the points you want to make more fully, do come back to that at that point.

Andrew Percy

I must apologise that I have questions for the debate in the House, so I will not be staying for the whole of the session. Following the pause in care.data that you have already talked about, the pathfinder areas were announced. Do you have any comment on the choice of those areas?

Professor Mathers

I think the pathfinder areas were chosen systematically and rationally. We wanted pathfinder areas that encompassed about 500 general practices. I think it is now about 350. It is a whole range of areas. CCGs volunteered to take part. There are two in the north and two in the south and west, and it is a whole range of urban and rural populations, and deprived populations and not so deprived populations. It seems to me it was a very rational choice to choose CCGs that were different from one another and CCGs that volunteered to take part.

Sam Smith

As far as we understood it, NHS England said they would write to all CCGs asking them to take part. We know that that did not happen and they were picked via a mechanism about which we have no information.

Andrew Percy

Are you satisfied that in terms of the care.data advisory group they were engaged with properly and that the issues you raised were adequately answered, or do you have any outstanding concerns about the role of, and involvement with, the advisory group?

Professor Mathers

The advisory group is not a decision-making body. Representing the RCGP, we were listened to, our concerns were addressed very seriously and appropriate written responses were produced to every issue we raised. We have had a very large number of meetings. It has not been done very quickly and superficially; it has been done with us being fully informed and given all the information we need to answer our queries.

Nicola Perrin

I think the advisory group sees its role as a critical friend and, during the course of the last year, we have been both critics where necessary but we have also been friends where helpful. There were some initial questions around communication, but I think we have resolved those and we are working together effectively as a group. I have not felt that we are not being listened to.

Sam Smith

I agree with those comments. The questions we have are very much the last ones to be answered, but the process which the group follows has been acceptable. For example, we have seen lots of communication material. For the last three meetings, we have seen three different drafts of the care.data opt-out materials, which have been different. That is a good process. When a decision is made about what the opt‑out does, I am sure it will be fine, but that is not a question for the advisory group but for the programme board and the programme itself.

Nicola Perrin

There is a wide range of stakeholders on that group, and the fact that often we are all giving consistent messages is, I hope, helpful to care.data in establishing its next steps.

Barbara Keeley

In its report to the care.data programme body, the Independent Information Governance Oversight Panel sets out 27 questions, with which I am sure you are familiar, that need to be answered satisfactorily by the board, and seven conditions that need to be met. Looking through those questions—I am thinking back to previous sessions we have had—I feel that the picture is somewhat clouded by what has gone before. I look at a question like, “How do I know my data are safe?” and questions that go on from there. We would like to have your input. Are those the right questions, and what progress do you see is being made towards them?

Sam Smith

If we are talking to patients, some variant of, “How do I know my data are safe?” is a question they ask. They want to know that their data being used by the NHS are safe, how that happens, whether or not there are conversations and there is a secure data facility which is being scaled up and doing more things. A secure data facility is a very good idea, and this Committee was instrumental in pushing forward that idea. The IIGOP has asked the question and the answer is, “What are you going to tell patients?” I suspect some patients are watching this briefing, but most will not. What are you going to tell them? Is that comprehensible, and will it make them feel safe; or will you tell them something that generates another 10 questions, none of which is answered, or to which you have no answers? I think that is the sort of question Dame Fiona is looking to get an answer to. It is not just that question, but the answer cannot raise another five.

Professor Mathers

I think the questions she raises in this report are entirely appropriate, but it has expanded the scope. It goes beyond care.data and it is establishing more general principles that would be applicable to other programmes of work. I think the questions are entirely appropriate.

Barbara Keeley

From the GP point of view, and we are talking to you as the GP on the group, do you believe GPs are able to answer those questions?

Professor Mathers

Not at this stage. Part of the pathfinder work is to ensure that all GPs and practices have a toolkit so that, if they do not know something, they know where to look or who to ask. It has become increasingly complex over the last year, and there needs to be space and a resource available to GPs to make sure patients are being correctly and appropriately informed, particularly about the implications of opt‑out.

Nicola Perrin

It is an extremely comprehensive set of questions. I would not be able to identify anything that is missing from it. I think we are nearer to being able to answer some than others, but they are all very important.

Barbara Keeley

Which of the questions do you think are furthest away? I suppose that the point we will get to today is when it might be appropriate to move with the pathfinders. How far away do any of you feel that is?

Professor Mathers

It is important to take this step by step. I would hope that by the summer we would know the answers to the majority of these questions, but we do not know until the pathfinders have taken place because it has been quite a slow start.

Nicola Perrin

Some of them, such as the one about safeguards, will hopefully become clearer with the CAG regulations. The opt‑out ones have to be clarified before the pathfinders can go ahead. Some of the ones about the data that have been excluded from the scope for the moment and expanding the scope in future do not necessarily need to be answered before the pathfinders start, but a clear process needs to be set out for how those will be answered going forward.

Sam Smith

I would agree with those statements. Tim Kelsey has previously said to the Committee that there are no artificial time scales, and I would echo that comment. These questions are interrelated. As we get closer to an answer, it is easier to answer more of them, which makes other questions easier, but I have no idea how long it will take NHS England. “What does the opt‑out do?” seems like a simple question, but they have been working on it since February and we still do not have an answer.

Barbara Keeley

You mentioned that there was not an open competition for CCGs to opt in to being pathfinders. Do you have any concerns about the pathfinders that are there? The question mark I have is: why three from one area? Why the whole of Leeds?

Sam Smith

One of the things they are testing is communications. CCG boundaries, especially in a city, are probably legacies of previous local government arrangement of wards. It is one side of the street and not another, so if you put up a billboard what do you do? It makes sense that they are some form of constrained areas, and one needed to be a city so you can test a city. We know that leaflet penetration in London was well under 50%. To run a good pathfinder there needs to be a city. As a result, most big cities have multiple CCGs, and I suspect Leeds is convenient, given where NHS England is based.

David Tredinnick

I have listened with great interest to what you are saying, but I want to ask you about the scope of these pathfinder trials. Do you think that the whole planned scope of the system, from collection to processing, and the use of data should be the basis of these pathfinders, or should they be used to test the effectiveness of the technical process? In other words, is there a risk that we are asking too much of the pathfinders and we will not find out enough, or that the results will be confusing?

Sam Smith

There are two aspects to that question. Can you get the data from the GP systems to HSCIC? Yes. There is an existing process being reused called the general practice extraction service, so you can run the query. There are a few low-level mechanical questions like, “Will a GP approve it?” but that is a problem that has been solved before. As to whether or not the data you get, when you get them to a safe setting, will be of any use, I would refer you to the expert reference group for care.data. HSCIC convened a group of experts who do data analysis on these sorts of topics. They had a list of things where NHS England and others said, “We use care.data to do these things.” They would ask, “In your area of expertise, here is the specification; here are the data you will have; here is the question. Will you answer it?” It will say, “We can do that because we will have four months of data and that is enough for this question.” In other cases, it will say, “No, because it is not in the specification.” There is a range of questions from a clear yes to a clear no. That expert reference group did some very good work and has produced a report, which I hope the Committee has been sent.

Professor Mathers

From the point of view of the college, we have to look at it as a whole system rather than just individual bits of the care.data programme. From our point of view, the comprehensive nature of the pathfinders will enable us to answer most of the questions outlined in the report of Caldicott’s independent group before Christmas.

Nicola Perrin

That is right. One of the most important things about pathfinders is to test the communications and understanding. You have to test that as the whole system, and I do not think that to cherry-pick different bits would work. Having said that, from a research point of view, we recognise that pathfinders will not be of enormous value; they are a limited dataset. The secure data facility is fairly locked down, for understandable reasons, and data extraction will also be limited. From a research perspective, we want care.data to work. If the way of getting it to work is to do it in a phased or staged process with pathfinders first, we understand that is the way it needs to happen.

Rosie Cooper

If the conditions that the Independent Information Governance Oversight Panel has laid down are met, do you think it reasonable that the pathfinders should go ahead on the basis of patients opting out rather than opting in?

Professor Mathers

My understanding is that legislation exists to say that opt-out is the way forward for care.data, and that has been our position. We think that opt-out should be the appropriate approach for care.data, for all the reasons outlined in previous discussions, in terms of participation and utility of the data being extracted and used for the benefit of other NHS patients. Therefore, from the point of view of opt-out, we think this is an appropriate way to implement care.data.

Sam Smith

That is a question to which there are a number of possible answers. It is very much easier to run a good opt‑out system than a good opt-in system. It is incredibly easy to run a poor opt‑in system. If you say that somebody has consented to the plan for care.data, or whatever replaces it, this runs for ever. What does that change as the programme changes? Is it new data, new treatment or other things? Is that something they should have opted in to again? Where do the boundaries arise? We would look at any opt‑in proposal that was offered. We have not seen one, and we have not had the time to put one together. The proposal set up by NHS England is an opt-out proposal, so we look at how we can make the proposals on the table adequate. We are aware that the British Medical Association has opt-in as a policy, and we very much look to see where that goes. If there was an opt-in proposal on the table, we could look at it. As to opt-out, that provides, as part of a national health service, some onus “to do the right thing”, for want of a better phrase. What does that mean? One of the descriptions of care.data that has been used is that it was the most data they could sneak past without anybody noticing and something else happened instead. It is a question of what is good governance, what does it look like, because there is then not quite a moral expectation but a cultural and ethical one of the various bodies involved that that is the level of engagement that you have had with the public, and they find out what you get is last February in the hospital episode statistics.

Professor Mathers

As I said in an earlier statement, the key principle for us is that the NHS and everyone who uses the data should be beyond reproach, and people need to know what they are opting out of. If those two conditions are met—hopefully, all this work is enabling that—that is the underpinning of our support for opt‑out.

Rosie Cooper

Nothing would give me greater pleasure than to say, “Jolly good. This is where we are.” For me, this is a question of trust. When I came in today, I was prepared to leave at the door a fair amount of cynicism, but in the past half-hour we have heard about minutes not being published as promised; whether the pathfinders were volunteered or chosen; whether or not people have been written to as promised; and regulations promised in the autumn are still not to be seen. You are almost saying it is reasonable that we should go for an opt‑out instead of an opt-in. My question to you is: from where we were before, what solid pieces of information land, as I would put it, are any different? What is different so you can tell me this is really going to be good, based on honesty and transparency? I have to say I have not seen many people keeping their word round here, I have to say.

Professor Mathers

We have moved an awfully long way since last February. A huge amount of time and energy has been expended. As Nicola was saying, a lot of time and energy has been spent on communications. The proposed communications I have seen for the opt-out and information leaflets are honest, straightforward, understandable and direct.

Rosie Cooper

We have not seen those yet; you have. When people say that minutes were promised and they have not arrived, and regulation was promised and it is not here—it is delayed until later in the year—you will probably start this without any regulation at all. It is ridiculous.

Nicola Perrin

I do not think it can start without the regulations.

Rosie Cooper

You are saying that absolutely no extraction will take place until this those regulations have been laid and have gone through the House.

Nicola Perrin

That is our understanding.

Sam Smith

That is our understanding. I would be utterly shocked if there was a different understanding. It has always been the case that there will be CAG regulations. Two things have changed since last February. There is a promise of a letter to patients, and Dame Fiona Caldicott has oversight. The question is: what does the letter say? That will say some things. Is that going to be happy? If you as an MP send that to all of your constituents, will your mailbag explode? We do not know what that letter will say; we cannot know. If there is a good opt‑out and a good process, we can look at that. We do not know what that letter will say. Why do we think there is optimism and hope based on the founding principles of the NHS which are continued in that vein? That is probably the only thing I can cite—and the fact there are people who can say, “You are not meeting an obligation to the people of England. You cannot do this.”

Nicola Perrin

Other things have changed since last February. The Care Act has clarified the role of HSCIC and has also given additional functions to the confidentiality advisory group. They need to be set out in more detail in the regulations but there is a starting point in legislation, which is a step forward. There is also the Independent Information Governance Oversight Panel. A huge amount of work has been done by the information centre to understand what has gone wrong in the past and learn lessons, and there is much more transparency about requests for data and to whom data have been given. There have been knock-on effects for the research community, with serious backlogs and delays in getting applications through. That is another set of issues, but it shows they are taking their responsibilities much more seriously.

Rosie Cooper

Do you think those responsibilities can be discharged with a fine of £500,000, or should somebody go to prison for breaches?

Nicola Perrin

I would be very supportive of much stronger and more meaningful sanctions for misuse. There is a very important discussion to be had as to whether or not criminal sanctions are the best way forward. They would need to be clearly defined to make it clear they are for misuse with malicious intent so you do not catch the accidental re-identification which is an honest mistake that is rectified very quickly. I think there is an important discussion to be had, and the sanctions need to be meaningful to ensure there is trust in the system.

Rosie Cooper

Would that apply when the hospital episode information was on the internet? Should they have gone to prison for that?

Nicola Perrin

I think it is the data user.

Rosie Cooper

But that was out there and people could use it.

Nicola Perrin

At that point, there were no clearly defined purposes for which data could and could not be used, so you are introducing sanctions within a framework of what the data can be used for.

Rosie Cooper

I am not asking for it to be retrospective, but if something of that order happened should that apply to people?

Nicola Perrin

I would hope they would not be given access to the data going forward.

Rosie Cooper

But they were in the past. When you look at the future, you always want to look at history. We are being asked to allow virtually the same people to let rip once again.

Sam Smith

I would hope that the secure data facility should prevent that scenario from being possible, not that it should not happen, and similarly a number of steps should be taken. Those steps are not now fully available. We can make things impossible to happen. If it cannot happen because the data are only in the secure facility in Leeds and remote connections, not shipped on DVDs to anybody who wants it, you can have a very different conversation. Should the people who have committed breaches in the past be prevented from accessing it again? Yes. That goes to what CAG can take account of in the regulations and what the regulations say. They are not yet published. There is nothing we can point to that says NHIS was one of the organisations that potentially caused a breach, or was one of the organisations where massive public concern was raised—we will come back to that in a second—so should they have access to data again? What are the rules that will be in place? We do not know because we do not know what CAG can say. Therefore, they do not know what it can take into account. They would like to take it into account, but that does not mean that legally they will be able to. What happens when it is clearly the fault of a large company that has committed a breach? The example I used, and everyone wished I did not, was a large university where a PhD student gets drunk. That should not kill the research programme; it should possibly be just a matter of telling the student not to drink quite so much. If we can work that element out, that is a different problem. There is a set of processes there. Where somebody is to blame and it is clear, that should be the case. We do not know what the regulations will say, so we have no answer to that.

Professor Mathers

We are strongly supportive of tougher sanctions for any abuse of data. The regulatory framework is a lot tougher than it was even a year ago.

Rosie Cooper

I am saying that it has to be criminal with prison, or the threat of prison, as opposed to money, which is no threat. If you are a multinational company and it is a fine of half a million, or whatever you like, you will pay it and do it again, but if the chief executive is going to jail it might be slightly different.

Barbara Keeley

To come back to one of Sam Smith’s points, in previous sessions I raised the fact that CAG allowed the use of hospital data for what was effectively a price comparison website for private hospital procedures, which I think is an abuse of patient data. Why should the details of anybody’s operation go for that sort of use? That goes to the point we have been considering right from the start, which is about reputation. If a PhD student makes a mistake because they have had a bit too much to drink, that is one thing because they have to get on and finish their course; otherwise, they will not have a career. However, if two blokes, if they are two blokes, have a website that compares prices, that sort of application can come and go. How do we reassure ourselves that we will stop seeing that sort of usage, which is an abuse? I cannot see a patient anywhere who would want their hospital or GP care data to be used in that way.

Sam Smith

That goes to two questions. One is that HSCIC can release data for the purpose of the promotion of health. What does that mean? Has it been written down at any point? The answer is: not that we have found. My understanding is that it will not be in the CAG regulations. To take your particular point, a company can be created and cause a breach and then shut itself down, and the same people start up a new company. Whatever the regulations say, they must take account of corporate history and also the individuals who caused a breach. When you make a request for data, you say who will have access to the data and equally their personal history so you cannot shut down the company and get away with it. Your reputation follows you, as well as the organisation. Equally, if an organisation and not an individual were to blame, they can get another job doing the same thing at a different company without being tarnished. If that reputation stays with an individual, they have a greater obligation to report wrongdoing because it will not be held against them unless they have done something, whereas if the actions of the company are held against an individual, who on proper investigation was not to blame, there is an incentive to keep your mouth shut.

Barbara Keeley

You have told us in your evidence that you have concerns about updated data access request forms because they do not require verification, even if a customer is a legal entity, and ask only for a company number. That seems the most cursory of checks on an organisation. The departure we have got into is away from the research community. Students and people forging a career in research have their future to think of and their integrity is important to them. Is the type of organisation I talked about, which throws together a website app and tries to make some money out of it, another concern that needs to be addressed?

Sam Smith

It goes to that point. In the research community, you have a culture where the people in it will generally stay there for their working lives. Nicola can speak to that point a lot better than I can. Companies have very different motivations from researchers and so should possibly be treated at least slightly differently, but not completely.

Nicola Perrin

A lot will depend on getting the right definitions in the CAG regulations to be clear about what purposes are or are not allowed and to limit purposes that are solely for commercial use. We have to recognise that pharma companies do some very valid and important research that improves human health. There may also be some commercial gain as well and we should not be stopping that, but we need to prevent purposes that are solely for commercial use. We are concerned that the CAG guidance needs to set that out more clearly. We recognise that there cannot be an exhaustive list of what is and is not allowed. It needs to go further than it goes in the Care Act itself, but our understanding is that that is not the intention at the moment.

Barbara Keeley

You understand that is not the intention.

Nicola Perrin

It is not the intention.

Barbara Keeley

That is a concern.

Nicola Perrin

Yes. Our other concern about the regulations is how they fit with CAG’s other roles which were defined within the 2002 regulations, particularly in relation to section 251 and the provision of approval for the use of identifiable information without consent. It should be very clear that they still have that function. They have had a very transparent process to administer it; they give robust challenge, but they also recognise why they have that function and do it very effectively. There is a danger that the two regulations could end up conflicting with each other. The full remit of CAG needs to be absolutely clear.

Chair

Have you set out what you think the wording should be? As a group, have you made clear where you think it is lacking?

Nicola Perrin

No. We had discussions with the Department of Health. They have said they will put more detail into the explanatory notes, but we have not yet seen their latest draft. Until we have seen their revised version, we have not provided wording.

Chair

As a group, have you made your own suggestions? What would satisfy you to see in those regulations? If you have done so, or are about to do that, would you send it to the Committee as well?

Nicola Perrin

We have suggested some things; we have not gone into detail, but we can do that, if it would be helpful.

Chair

Thank you. One final point. I do not ask about the culture among those who are going to receive the information but, as a group, do you feel that within the Health and Social Care Information Centre and NHS England, which to be fair led to a certain sloppiness in the way this was first set out, there has been a recognition and culture change about how we should be going forward?

Sam Smith

Within NHS England, no. Within the Health and Social Care Information Centre, they have a new chief executive in April who was appointed before this blew up. There have been lots of changes to HSCIC. We are having ongoing productive discussions. We are being listened to and steps are being taken. We can go into more detail.

Chair

Could you set out what you think are the issues that need to be resolved within the culture of NHS England?

Sam Smith

I think that decisions are made and then are not reviewed in the light of further conversations. Taking the opt-out, which may not be the best example, what will it do? There will be one opt-out and all the problems that come from that decision seemingly cannot be entered into. I would not say “neglect”, but it is a lack of attention to detail.

Professor Mathers

In my view, there has been a raising of consciousness in NHS England. They are much clearer about what they can or cannot do and much more reticent about just going for it without ensuring there is adequate consultation and feedback. My view would be slightly different from Sam’s.

Chair

You feel there is a response.

Professor Mathers

This time, for NHS England, they have been amazingly responsive in my experience.

Nicola Perrin

I would agree there has been a significant shift in the information centre’s attitude to all of this. I would support Professor Mathers’s comment that the parts of the care.data team we have had exposure to—“NHS” is too broad a term—do get the issues now.

Valerie Vaz

I suppose it was the screech of everyone else that caused NHS England to backtrack on certain things and they feel there is not much accountability, which is why we are all sitting here today discussing this. I want to pick up one or two points on the pathfinders and then maybe ask a series of questions that have arisen from your evidence. You talked about NHS England not writing to everybody but just a few CCGs for the pathfinders. Are you satisfied that patients were involved and properly consulted on that? Is there any way of finding out or knowing?

Sam Smith

It was different within different areas, and I do not think there was one answer. One of the pathfinders and one of the CCG’s patient groups was not consulted. I do not know whether that was because there were multiple patient groups. You will have a range of answers. I do not think there is a single answer.

Professor Mathers

Decisions were made pragmatically rather than ideologically that everyone had to be involved at every single stage of this and it needed to be done. My understanding is that CCGs were selected on the basis of them volunteering. Everyone was invited, but it was the volunteers who have taken part in the pathfinders. There has been variation in the amount of patient involvement. There has been some patient involvement in all of them but it varies.

Valerie Vaz

Were patients written to and told they were part of the pathfinder?

Professor Mathers

That is part of the pathfinder project; they will be.

Valerie Vaz

Were they all written to?

Professor Mathers

Yes, they will be.

Chair

To clarify it, they have not been written to yet but they will be.

Professor Mathers

Not yet.

Valerie Vaz

You said that they were volunteers. Did money change hands?

Professor Mathers

I do not have the foggiest idea.

Valerie Vaz

We do not know whether they were given incentives to be part of the pathfinder.

Sam Smith

That is a question for NHS England. I believe the public statement was that costs would be covered. What that means I do not know. I think the intent on the part of NHS England was that this would be cost-neutral to the CCGs, but then you get into questions of accounting.

Valerie Vaz

Professor Mather, can I turn to some of the comments you made initially? You said that legislation was adjusted. Could you say which legislation that is?

Professor Mathers

Provisions were put into the Care Act just before Easter of last year about “not for commercial purposes”. This is for the benefit of NHS patients and the NHS. As Nicola has pointed out, in some circumstances, the data may be available to pharma companies, but that is in the interests of direct patient care. I think that was the phrase that went into the legislation.

Valerie Vaz

When you refer to legislation you mean the Care Act.

Professor Mathers

Yes.

Valerie Vaz

You talked about a range of committees overseeing this. You mentioned at least six. Could you name them?

Professor Mathers

I am sorry about the acronyms. There is GPESIAG, which is the General Practice Extraction System Independent Advisory Group. I apologise if that is not right, but that is for GP release of data approval. DAAG is the Data Access Advisory Group; HSCICCAG is HSCIC’s Confidentiality Advisory Group; there is the Independent Information Governance Oversight Panel; there is the Expert Reference Group; and there is the Pathfinder Programme Board. I do not fully understand how they fit together, but they all have distinct remits and functions.

Valerie Vaz

Does anybody know how they fit together?

Nicola Perrin

Some but not all of those. On top of that we have the National Information Board and the National Data Guardian.

Valerie Vaz

Presumably, we can get that from somewhere, can we? We do not want another organogram. Do you want to comment on that, Mr Smith?

Sam Smith

Probably not briefly. Possibly, the short answer is that they do fit together and there is overlap. Many of those, hopefully, have an affiliation to HSCIC, so they may wish to write to you with an explanation or diagram that would be very useful clarity for everybody.

Valerie Vaz

I make a general comment and ask a question of all of you. Lots of research took place prior to care.data. What is so different that has to happen now in terms of research? You say it is useful for patients, pharma companies and so on. What is so different now about the research, evidence and information you get that you were previously able to access?

Nicola Perrin

If care.data goes ahead, the real difference will be that we will be able to link primary and secondary records from GPs and hospitals together with other related datasets, disease registries and prescribing data, and to do it on a population-level basis. That is the key difference. These things have happened on a small scale, but, if you can do this nationally, you make use of the NHS’s unique asset which is the cradle-to-grave records of 50 million people. That means you can ask questions at a population level that you cannot ask with limited datasets. It also means you can ask questions about much smaller groups. You can look at rare diseases, or unusual conditions, where it is difficult to conduct a clinical trial—for example, the impact of prescribed medication during pregnancy and medication in children. For that kind of question, it is the scale of the dataset that would make a real difference. This has been done on a small scale with CPRD already, to add another acronym to the equation.

Chair

For those following this, can you say what that is?

Nicola Perrin

That is the clinical practice research datalink. That is an evolution of GPRD, which is the general practice research datalink. What is different about these proposals is that they would open up access to data across all primary care records.

Professor Mathers

Care.data itself provides a fantastic opportunity for research. That is one reason why we think the benefits outweigh the risks, provided they are properly managed, for improving patient care. The linking of the datasets between the hospital episodes and care within the practice is where the real power lies in the programme.

Valerie Vaz

My concern is exactly what you have just mentioned: it saves clinical trials. I just wonder whether we are in the process of getting a massive amount of information about the population to save drug companies from doing their clinical trials and work. Some population studies have been going on, have they not? My question is: if someone has an idea for a piece of research, what is wrong with identifying, via GPs or different areas, which they must have done before, those patients and asking their permission? You will find that patients probably would like to help further research. It seems to me you have a massive amount of information about people, which you really do not need to have, that means people can dip in and dip out. I am hoping you will tell me that there is an opportunity for patients to know what information about them has been passed on.

Nicola Perrin

I think there are two slightly different issues within that. You can ask very different questions if you are looking at real-world effects in the population. Of course, there are examples where you can do it on a small scale and ask every individual patient, but you will not be eliminating clinical trials. This is not about novel drugs before they have been approved; it is looking at the effects of drugs that are already being prescribed and picking up side effects which would not otherwise be seen if you were looking at just a small population. It makes it that much easier. Because one can look at large numbers, the costs and resource implications of asking everybody separately to consent would be huge, and would reduce the amount of research that could be done. You also end up with that sort of opt‑in process. You will often have a skewed dataset which can lead to an unhelpful and potentially dangerous bias. You will have some groups that are much more reluctant to give consent and they are missing from the dataset. Therefore, population-level data are of the most value to get the best possible answers from the research.

Valerie Vaz

It seems to me that not everybody will be on that particular drug. If it is about the effect of a particular drug on a person, or group of people, and you want to find out how they have gone through the system, you do not have to have information about everybody, do you? If it is a rare disease, you do not have to have information about people who do not have it; you can target your research. People make an application for the information to do that research. You target it; you do not have everyone’s information. I am thinking about being very safe about people’s personal data.

Nicola Perrin

This helps you to target it. The resource implications for a researcher from a charity or university to contact every single GP practice to find out if they have that one patient in their practice are huge, and it also puts an added burden on the GP practice to respond to all these separate inquiries. If you can do it at national level with appropriate safeguards, it is the most effective and efficient way of getting the data.

Valerie Vaz

We have to do exactly the same for FOIs. We are continually having to ask CCGs and everybody else under FOIs, so there is a huge cost implication. It seems to work for one person and not another. Mr Smith, can I ask about the report on personalised data usage? In your evidence, you suggested there was good news too. Can you expand a bit on where we are on that?

Sam Smith

Everybody would like to know where their data have been used, and HSCIC can now tell them. Back in February, you asked them where they send data that month. They could not answer the question. Now they have worked it out and can tell you exactly which studies you are in, going to your question, “Do you have this rare condition?” or, “Are you in the control group for that study?” which is normal people selected at random. Where did your data go? “You went to these studies, and, after however long it took to do the research and publication, this is what we learned as a result.” You tell patients about every single usage. When it is everything, what causes concern is that people think things are being hidden. If you say, “We will tell you everything. Here is the list,” people can go through it and say, “I’m not sure about that particular project, but I’m happy with all the others.” It is not trusting that the governance is good, or trusting CAG or the other parts of the alphabet soup; it is being able to see this is what happened. “This is where my data went, this is why, and I like those projects.” If you tell people that, it massively reassures them. They do not have to trust the system; they can read it and know. If you have fundamental consent, based hopefully on where we are going, and you opt out of all research, your research section is empty. You may have been in some studies in the past and they have been published, but you know where your data have gone. If you start having that conversation and provide that electronically to every patient in the country, it is a confidence-building measure. Going back to Rosie’s earlier question about trust and why we think this is a good idea, there is what the Royal Statistical Society calls the data trust deficit. If you ask a person how much they trust an organisation, and ask the same person how much they trust that organisation about data, the data one is always a lot lower than the organisation itself. That sort of transparency is a confidence-building measure. Some time last year, a company in London which did breast cancer screening was fined a lot of money because it had a single username password for the entire company for all their patient data. That was front page news in the Metro for two days. Nobody knew who it was. It could have been you, but you did not know, whereas if you had a list of where your data had gone, with all the direct carers and all the secondary usages, the NHS statement can be, “Go and read your data usage report, which is a big red box on page 1 telling you what happened. Click here to find out what happened, what we have done about it, how it affects you and what you need to do,” that would be very reassuring. It is not a question of, “Well, that might have been me.” It was a bad story; it really should not have happened, but fear comes from, “Was I involved, or does it affect me?” That is one of the things personalised data usage reports are trying to achieve.

Valerie Vaz

GPs do text. When you go and see your GP they can ask you. The costs are minimal. Given that Korea hacked Sony, do you think our data are 100% safe?

Sam Smith

I do not think anything can ever be 100% safe, because you get into really odd cases. I was talking to a journalist who writes articles about pharmaceutical companies. The people he covers know when his wife gave birth and his kids’ birthdays. He is massively identifiable, and he is giving data to the people he writes about. The only way you can make it 100% safe is for him and his family to be able to opt out and not to be in the dataset, so you get into certain cases. Is it possible to build a system with proper consent, a secure data facility that checks who goes in and data usage reports, all overseen by statutory governance? Can that make it safe enough that the vast majority of people say, “Those are the safeguards. All of the benefits come from research. We like the potential cures, and this is a good thing in a national health service?” A trade-off can be found. I do not think the current care.data programme is that trade-off. I think that bits of what HSCIC are doing are moving towards that, but that is what this Committee and others should have as a conversation when this is in place. What do we want that to look like, and where do we draw the boundaries?

Professor Mathers

I do not think it can be 100% safe, but I go back to my opening remarks. We have to be beyond approach and do our absolute best within the constraints of our resources to ensure it is as safe as it possibly can be. The benefits should outweigh the risks. Most patients are willing to share their data if they are being used for altruistic purposes: to improve other people’s care, to find the side effects of drugs or whatever. It is about making sure that people who do not opt out understand that, although it is not 100% safe, it is as damned near safe as we can make it, and that their data are being used for appropriate altruistic purposes, in which case most people will retain trust in the system, in our belief.

Nicola Perrin

I would agree. I do not think we could ever say it will be 100% safe, but the important thing is that, if you cannot eliminate the risks, you make sure you can manage them appropriately, proportionately and effectively and ensure the benefits outweigh the risks. If I may return to Sam’s comment about notifying everybody about how their data are used, there is a real benefit in having a clear and transparent audit trail, but it is worth recognising that it personalises the use of your data much more than it would be. If a researcher used your data, they would not know it was yours; they would have a line of code with a whole series of numbers and it would not look like a person. My concern would be that if you saw, “Researcher X used my data,” people would have a very different impression of what is actually involved when researchers use patient data.

Chair

Mr Smith, following up the points that have just been made, for you is there a point at which that balance will tip in favour of being confident to share your personal data through this programme, or do you feel that this is such a fundamental step too far there is no point at which you would feel happy to sign up?

Sam Smith

That decision is made at a different point for everybody—for example, the previous example of the journalist. There is probably nothing you can do about that. Equally, there are people with rare diseases who put all of their medical records freely on the web for everybody because it might help somebody. Those are diametrically opposed. In likelihood, everybody is in the middle of the spectrum. Most people probably do not want to think about it; they just want the right thing to happen. What that means is probably the topic of the report by this Committee. If somebody does not want to pay any attention, what should happen and how is that treated safely? In the same way, when somebody goes to hospital it is not that nothing bad will ever happen, but there are processes whereby if something happens it is learned from. That may be very sad for you or your relative, but equally the system as a whole should run.

Chair

I take your point that the tipping point will vary from person to person, depending on how they feel about these issues, but one of the disadvantages is that, the more safeguards we pile on, the more bodies we end up adding to the list. I think we got to more than seven in the end when we looked at the number of people with oversight. Do you think that, if we keep piling on more and more layers of safeguards, in the end you can make the programme less effective without adding extra reassurance?

Sam Smith

Yes.

Chair

You feel that is also an issue.

Sam Smith

There should be appropriate governance, and the answer is not that constantly adding more bodies is better. There should be statutory oversight and information governance in the NHS, again. I think that in the 2014 report of the IIGOP there are case studies going to that point. That should be put back. That is not to say there should be multiple statutory bodies. There should be one based in medical ethics that is responsible for that aspect. If care.data had been designed by somebody with a medical ethics background, it would not look anything like it does now, and the programme would probably have been running for 18 months. Some people would have opted out. Those are the people with the most concerns, and everyone else would probably not have noticed.

Chair

The fundamental problem is that we started from the wrong place.

Sam Smith

The wrong ethos. It was designed to be the most data they could give to certain types of companies without the public becoming unhappy, and they misjudged it.

Barbara Keeley

I have a few more questions to put to medConfidential, but others on the panel might want to comment. You have raised with us the question of putting the National Data Guardian on a statutory footing and pointed to a couple of examples from her report. In one case, her group tried to advise on the opt‑out leaflet, which was disastrous. They were told it had gone to the printers and that was that. The report also indicates that they have not been able to achieve the cultural change that they called for in relation to information governance. You have just said you think this should be put on a statutory footing, but what do you see as the main benefit of that?

Sam Smith

The main benefit we would see is that, certainly in that case, NHS England would have had to have consulted IIGOP rather than notifying them after they had sent it to be printed. When somebody can say no rather than say no and be ignored, that is a very different world.

Barbara Keeley

Can I draw out some of the things in your briefing that we have not touched on? You still have concerns about the 9BNu4 opt‑out code and whether the use of it will affect the care that you receive. We have been informed that that is an issue and patients who have opted in that way will have to be written to. Is that also your understanding, and is that still a concern?

Sam Smith

That is still a concern. Just before the Committee started I was handed by the Clerk a copy of a letter from HSCIC which goes into more detail than we have seen before. As of yesterday, when we last checked, NHS England said that opting out with 9Nu4 will not affect your direct care. We believe that intent could be true. We wait to hear from the people who give evidence after us what is there, because I think that is a question you have to ask NHS England.

Barbara Keeley

I am sure we will. You said you had not seen the list of medicines that are considered sensitive and which will be removed from the dataset, and presumably that would be a concern.

Sam Smith

In November, I was told that it would be published within days, and it still has not been. I do not know what is in it. I know that, when the care.data specification was originally published, we went through it in more detail than everyone else had, and the changes that I have in my spreadsheet reflect various things that really should not have been in it.

Barbara Keeley

You also talked about consultation on the dissemination and use of sensitive data. In previous sessions on this issue, we touched on the fact that the most sensitive information in GP records is often the GP’s handwritten notes. In a previous session I raised the fact that there were already research projects picking up those notes from GP records. That is still a concern. What is your view about what audit or transparency there should be? We were told by somebody who knew about particular projects that that was going on, and yet it is undoubtedly the case that the patients involved, who were having their notes copied, did not know that was happening.

Sam Smith

We would hope that a patient who ticks the box which says, “I would like to opt out of everything,” can say, “I have this condition and I want to opt in to that.” If a patient says, “I’m completely happy for this to go on,” in that particular case, the most specific objection is the one that should be applied, or the consent. You can override them and it gets complicated very quickly.

Barbara Keeley

The question was specifically: should there be uses of often much more sensitive handwritten data, not the codes referring to dates of birth, conditions, when you were in hospital and what procedures you had, but whatever the GP writes down? We were given examples of research projects where that information was being used. Has that been discussed in your group? Have you raised it? I had an issue with it. I just wonder whether it is also an issue for you.

Sam Smith

We recognise many very obvious issues that come up from there. To say it should never happen is not the question. This is a question we would look to discuss with the research community, the GP community and the affected patient groups for that condition. What is appropriate for this case and this type of project? That is why, for general research, the answer is that you go and ask CAG and possibly ask another body as well. What should the process be rather than any particular project? Generally, there should be personal consent for looking at notes, but I am not aware of a deep process there. Possibly, that does not answer your question.

Barbara Keeley

It might be one that your group could answer. I know that medConfidential had a lot of issues about data reuse agreements and the fact nobody would really know who was using their data. When we asked about it, we were not always told, or were told that people did not know who the end user of a data reuse agreement was. Do you still have those concerns?

Sam Smith

New contracts came into force a few weeks ago which require the people who use it to fill in a form. Whether that is all cases or whether they will be published in a register, we do not yet know. It could be solved; it could be just as much of a problem as it was before, but the main problem with reuse agreements is the fact that it is commercial reuse. It is the commercial bit that is the underlying problem; reuse is just a second level there.

Barbara Keeley

Thank you for your briefing; it was very helpful. Any final thoughts?

Professor Mathers

To answer Dr Wollaston’s questions about governance, it is the law of diminishing returns. There comes a point where the governance itself prevents the project being discharged either efficiently or effectively. In terms of the personal level at which one is prepared to share data, at what point do you reach that tipping point? Personally, I think we need to wait to see the results of the pathfinders. The pathfinders have been crucial in ensuring that care.data goes forward or not. There needs to be a very clear review of the pathfinder results. The pathfinders are not just a step to implementation; they are another opportunity to pause and say, “Have we got it right here? Are we answering the right questions? Have we covered all the bases? Have we addressed everybody’s concerns?” before rolling out any further parts of the programme.

Valerie Vaz

Who does that? Is it NHS England who will do that? Is it the people who have organised care.data? Will they say it is a success?

Professor Mathers

It has to be the programme board for the pathfinders, and that has on it representation from all the different stakeholders. It is not just NHS England. We have a role in the advisory group to say that we think this should be done.

Valerie Vaz

You would be contributing to that process as a group.

Professor Mathers

Yes.

Sam Smith

The answer is that it is an NHS England question. They can listen to whoever they like, but it is a decision for them. The advice of the Information Commissioner’s Office is that you cannot write to people and say, “We might do this.” You have to say you are going to do so. Equally, if the letters fail as badly as delivery of the leaflets, we would not have done fair processing, as it is called, adequately. Therefore, you cannot extract and there is a breakdown and review. It was originally two steps and they were merged into one. I think Dame Fiona has a role in that, about which I am not entirely sure. The ICO and advisory group will take a view, but it is up to NHS England what they take account of, and whether or not there are other factors to take into account.

Valerie Vaz

There is no role for elected representatives.

Sam Smith

I would imagine the Secretary of State can take a view, but I am not quite sure whether Parliament gets a say.

Valerie Vaz

Or come before us again.

Sam Smith

I suspect that will not stop you.

Chair

It is perhaps a role for our successor body. Thank you very much. Before you depart, I mentioned that there would be an opportunity for you to raise any issues you did not think you had been specifically asked or had been covered. Is there anything else that you feel we need to take account of?

Nicola Perrin

When I was asked to give evidence today I sent a message round the sector asking whether there were any real points they would like me to raise. We all think it is extremely important to get care.data right and that needs to take as long as it takes, but in the meantime it is worth drawing the attention of the Committee to the significant delays that have been caused to researchers in accessing information from the information centre. There was a clampdown on any access. HSCIC are now open for business again and they are getting through the backlog, but in the meantime there have been a number of significant delays, including the accessing data that are non‑identifiable and are at aggregate table level and could be publishable. It is important for you to be aware that these delays are happening and they are preventing very valuable research as a result of the uncertainty about care.data, so the sooner we can get everything clarified the better. I was inundated with examples and I am very happy to pass any of them on, if that would be helpful.

Chair

It would be quite helpful to have an idea of the level of delay and how that is impacting on important research and therefore patients ultimately. It would be helpful to have a note from you and those you represent about the extent of it.

Nicola Perrin

We would be happy to do that.

Rosie Cooper

Would you copy in NHS England so they know what they have done?

Valerie Vaz

You said something about asking the sector. Can you say whom you represent?

Nicola Perrin

This was not comprehensive research, but it was particularly across the medical research charity sector. Charities were reporting examples that they had heard from researchers they are funding. It is quite a broad range and included some of them.

Chair

It would be useful to have examples and an idea of the severity of it. Are we talking about weeks or months?

Nicola Perrin

Months.

Chair

We are talking about months of delay, and also the kinds of projects being impacted by this. Whom do you hold responsible? Who would be in a position to move it on while we are waiting for this to be resolved?

Nicola Perrin

Some of that is the information centre and some is the result of an increasingly complicated and fragmented approval system, people feeling that they have to duplicate applications and go to a number of different bodies. Because of the uncertainties, there is a risk-averse approach to dealing with these applications. A number of the case studies commented that individuals at the information centre were extremely helpful and insightful in their advice but, regardless of that, there were still a number of different approval processes, and the extra complexities in the data-sharing agreements were not always proportionate to the type of data being made available.

Chair

That is very helpful. Thank you for coming this afternoon.

Professor Mathers

Unfortunately, I was asked whether I could come to today’s session only last night, so we have not had time to consult our members. However, in previous discussions at our council, the members have supported the progress that has been made with care.data.

Sam Smith

I think there can be a good outcome, and I hope we get there. I like the fact that the researchers Nicola funds, the institutes and all the good work that is done produce good outcomes for everybody. It has to be done safely.

Chair

That is a good closing comment. Thank you very much.

Witnesses

Tim Kelsey, National Director for Patients and Information, NHS England, and Dame Fiona Caldicott, Chairman, Oxford University Hospitals NHS Trust, gave evidence.

Chair

Good afternoon, and thank you for sitting through the first session as well. It has been very helpful. Perhaps we could start by asking you to introduce yourselves and your role for those who are following from outside the room.

Dame Fiona Caldicott

Thank you very much, Chair. My background is as a clinician. I started my career in general practice and went into psychiatry. I became involved in the world of confidentiality in the ’90s. I was involved in producing a report for what was then the NHS Executive, which led to the establishment of Caldicott guardians in all the provider units in the United Kingdom, who I think have played a role in assuring patients that data is kept confidential and used for the purposes for which they have provided it. I had a break from that particular activity until 2012, when I became chairman of the National Information Governance Board, which at that point had only 18 months to run before it was disestablished. Since then I have been involved in working for the Secretary of State for Health on an information governance review, which came out of the listening exercise for the Health and Social Care Act. That led to a report which had 26 recommendations, I think it was, about how information governance could be improved in the country. From that came the establishment of the Independent Information Governance Oversight Panel to try to ensure that some of our recommendations were implemented. Indeed, the Government accepted all of them in 2013. That is what we have been doing for the last year. In November, the role of national data guardian was established by the Secretary of State, and I was asked if I would take it on as the first post holder. As the title describes, it relates to England and is about health and social care data. I thought the word “guardian” was extremely important. One of the things that have happened in the recent past is nervousness, if I may use that word, on the part of the public about what happens to their health and social care data. As a clinician, but also a patient at times and a member of the public, I recognise the crucial importance of the public having confidence in those they consult about their health and social care needs. It seemed to some of us that that trust and confidence had weakened, hence the work that has been done to ensure that the balance between protecting information and confidentiality, but also ensuring that information is shared in the patient’s interest, was acceptable to members of the public, and that it was a balanced exercise. One of the things we found in the review was that the sharing of information in the interests of the patient/care user was not as strong as it needed to be to give the best possible care. That is the background to the new role. It was established only in November. In the last two years we have worked with a very small panel. One of the issues is the resource to support the work, and that is being considered at the moment. As you have already heard, there is also the question of putting the role on to a statutory footing, which relates to, yes, the independence of the role, but also the authority and the extent to which somebody holding it can exercise it and ensure that the standards we want for the whole of the health and social care system are established throughout and are in the patient’s interest whenever they present to our services.

Chair

Thank you. That is a really helpful background. Before I come back with some more detailed questions, perhaps, Tim Kelsey, you could set out your role as well.

Tim Kelsey

I am Tim Kelsey. I am the national director for patients and information in NHS England. I was also appointed by the permanent secretary to the Department of Health to be the national information director who chairs the National Information Board. I can you give more details about his role should that be necessary. In addition, I am also the senior responsible owner of care.data. To make one point clear, the governance of care.data is a very important issue and has been reviewed and amended over the last several months. It is a national informatics programme; it is not an NHS England programme. As a national informatics programme, I am accountable as SRO to the informatics accountable officer in the Department of Health, who is then accountable to the Secretary of State directly. The Secretary of State takes a great deal of interest in this programme. When we come to decision making on how the pathfinder process may or may not be initiated, it is in the context of a direct line of accountability. It goes from me to the Department of Health. NHS England funds part of the programme, but it is not the sole or discretionary decision maker.

Chair

Thank you very much. Can I return to you, Dame Fiona? Could you set out for the public in more detail, following on from your initial piece, how you will be able to hold this system to account and answer the kinds of concerns you heard raised in the previous panel? What are your powers at the moment? We have heard that you would like to have those powers on a statutory footing, but, as things stand at the moment and we move towards the pathfinder projects, are you satisfied that you are able, if necessary, to call that process to a halt? What influence and power do you have to reassure the public?

Dame Fiona Caldicott

As far as the pathfinder stage of the development of care.data is concerned, I have a very clear remit from the Secretary of State for Health. I have to be satisfied that the conditions we have put to the care.data programme board, in order for any data to flow from general practices to the Health and Social Care Information Centre, are met. That piece of responsibility is very clear. We already have it under the Independent Information Governance Oversight Panel in relation to care.data, but it has been strengthened in the words around the national data guardian. In terms of authority in other respects, this is to a large extent to do with building good working relationships. There is a clear remit in the terms of reference as drafted—they are still at draft stage—to work with the Information Commissioner’s Office and the Care Quality Commission, because they do have statutory powers. There is an expectation that, if we encounter issues that we think are not in the public’s interest, we are able to refer them, through partnership working, if you like, to whichever of those bodies is the most appropriate. There are some powers in terms of trying to influence. It is clear to me already that the CQC and the ICO are going to take that relationship seriously. We are setting up meetings to look at how the working together will operate and may well reach the need for a memorandum of understanding. While we are not a statutory body or person, there is a lot of goodwill in the system to ensure that we are able to advise where appropriate. There are strong links with the National Information Board, the new Information Governance Alliance and other bodies within the system. I feel confident going forward that because of the strengthening of the role, even though it is not statutory, more notice will be taken of what we have to say.

Chair

We will come later to the 27 points you raised, so I will not pursue that now.

Tim Kelsey

Perhaps I may make the point that, although it may not be statutory, the objective of the entire programme since we brought it to a halt, and subsequently when I became SRO, has been to co-produce at the most fundamental level in every direction both the design and culture. I am sure we will come to the cultural issue raised earlier. The culture of the programme is fundamentally committed to a level of co-production and oversight on a scale and with a commitment that, frankly, I have not often seen in public service programmes. Regardless of statutory authority, the programme board will proceed with this only if Dame Fiona is satisfied. The CMO—chief medical officer—whom we invited to the programme board to take an independent view, has passed on that responsibility to Dame Fiona as well, so it is a very fundamental part of the commitment. We have to be open, transparent and committed to getting this right. It may not be statutory, but we are bound by Fiona’s position.

Chair

Thank you for clarifying that.

Barbara Keeley

This may not be a question you can answer. I do not see a reason for it not to be on a statutory footing. I understand the Minister has said it will be done at the first suitable legislative opportunity. We were chatting among ourselves before the panel started. We think that could be next week, because this Parliament has so little to do at the moment, apart from the meetings and hard work that we do on this Committee. As to the concerns highlighted in your report, there are two things. You tried to stop a disastrous leaflet going out last December/January. That would have been a very sensible thing to do because it was a disaster. We were told that it had already gone to the printers. There is also the point about cultural change. Dame Fiona, do you believe it would be right to put your role on a statutory footing?

Dame Fiona Caldicott

I do. Can I take this opportunity to say how much I welcome the support that is coming from the political parties? Initially, the suggestion came from members of the public and medConfidential. The support for that development has grown until the discussions on Mr Lefroy’s Bill took place. I think both of the major parties support it. It would be very helpful. You could think of the February leaflet as a little bit of a low point or quite a bit of a low point.

Barbara Keeley

We thought that too.

Dame Fiona Caldicott

There was a lot of learning from that, but, as the year has gone on, as Mr Kelsey has said, there has been more acknowledgment that there are those of us within the system who are very concerned to get it right for patients. There has been closer working. None the less, I think there is an opportunity in the statutory nature of it. I certainly learned as chairman of the NIGB, for the 18 months that I did it, that it is possible to have all the key people in the room and for the work you do to be promulgated out to where it will be most useful and taken real notice of. I have had that experience, which leads me to think that this would be very welcome, given the developments that have taken place in information technology in recent years where the public are much more alert to the possible dangers to their information and want to know the answers, as you have already heard in the earlier session and in your previous hearings. We are at a point where we cannot avoid strengthening the reassurance to the public that there is someone with a body supporting him or her, giving this issue of trust in the system and how data are safeguarded and appropriately used as much attention as it deserves, with the people who are trying to implement change and do all of the things we want done in the interests of improving health and social care.

David Tredinnick

I want to talk to you about the basis for selecting the pathfinder areas. Can you give some indication of how this was done?

Tim Kelsey

By its nature, it is rather a complex programme. Let me give you some straight facts about the process. There was a panel for the selection of the pathfinders, which consisted of the RSGP, BMA, Healthwatch England and also a number of NHS England’s voluntary sector partners, which is a group that NHS England has brought together. Subsequent to their independent selection of the pathfinders, after volunteering had taken place—so pathfinders volunteered—one of the criteria, going to the point about patient involvement, in order to be accepted, having already volunteered as a potential pathfinder, was that you had to have the assurance from your local Healthwatch that they felt properly engaged, and patient participation groups from GP practices in the pathfinders also had to give an assurance that they had been involved in the development of the proposal.

Chair

Mr Kelsey, can I clarify one point? Were people invited to volunteer, or was there a universal invitation to all CCGs to volunteer, because there is a difference? If you do not know that you could volunteer, it is different.

Tim Kelsey

We wanted this to be a very concentrated experiment in setting new standards for fair processing. We were approached, unexpectedly, by rather a large number of CCGs.

Chair

But did every CCG know it could volunteer, or were certain ones approached, tapped on the shoulder and told they should volunteer?

Tim Kelsey

No; we did not tap CCGs on the shoulder. I cannot tell you that every CCG knew. We announced our intention to run the pathfinders, but we were approached very quickly by quite a large number of them. So, in the end—

Chair

That is not a very clear answer. There is a difference between putting out a general notice saying, “We’re looking for volunteers,” and phoning up a selection whom you would quite like to be volunteers and saying, “Could you please apply?” Either it is open and everybody knows there is an opportunity to volunteer, or you have a group selected by a group of people who have decided they would like these people to volunteer. There is an important difference, surely.

Tim Kelsey

I agree. What actually happened was that a group of CCGs chairs were aware we were moving to this space, although we had not publicly announced it through things like the commissioning—

Chair

How were they aware? Did somebody phone them up? Did somebody make them aware? Clearly, there is a difference.

Tim Kelsey

It was very widely known among the commissioning community—

Chair

How was it widely known—by word of mouth?

Tim Kelsey

I will find out, but it was not—

Rosie Cooper

Tarot cards.

Tim Kelsey

No, no, no.

Chair

There is a difference, is there not, between approaching people and saying by phone call or e-mail, “We’ve got this opportunity for you to apply,” to individual—

Tim Kelsey

I will investigate how it was done.

Chair

It would be helpful to know, because how the selection was made is of interest.

Tim Kelsey

I totally understand that. I will find out.

Rosie Cooper

Chair, this goes to the heart of where the distrust comes. Statements are made throughout these hearings, and when you test them they fall apart, like this. You cannot say they volunteered to do it. It falls apart because you do not then know the detail of whether they did or did not.

Tim Kelsey

They all volunteered and were then independently assessed by a group of independent people.

Barbara Keeley

But they self-selected.

Tim Kelsey

They self-selected.

Barbara Keeley

You did not go out and ask for volunteers. They self-selected themselves.

Tim Kelsey

That is correct.

David Tredinnick

Okay; shall we proceed, Chair?

Chair

Yes; let’s move on.

David Tredinnick

So we have established that. Do you know how many of the practices in those areas will be taking part in the pathfinder project?

Tim Kelsey

At the moment, 80 practices in three pathfinder areas have said they want to participate. We anticipate it being significantly more, but it varies by different CCGs and how far they have got in their activity and conversations with different practices. In Blackburn with Darwen all GP practices are participating. I can provide figures for the current state of play in West Hampshire. It varies on a day-by-day basis, but as of today 80 practices have said they wish to participate.

David Tredinnick

Is there anything about this process that you would do differently now that you have been through it?

Tim Kelsey

For the pathfinder selection?

David Tredinnick

Yes. We have had one or two concerns raised this afternoon about selection, and I imagine you are going to write to us about that.

Tim Kelsey

Yes.

David Tredinnick

From what you know now, would you have done things differently at this stage?

Tim Kelsey

Well, no, I don’t think so. The CCGs are not represented at the table here. It is a shame that the CCG chairs are not here, but the process of their selection was robust and independent, and as SRO I would not have changed it.

David Tredinnick

Thank you.

Chair

I do not know whether you can answer a question raised during the previous panel, which was whether or not the pathfinders will be paid. The last panel could not answer it. Are you able to say?

Tim Kelsey

I was at the back when you asked that question. We will provide the Committee with a note of the amount of money which may or may not be paid to pathfinders for material production and so on. They are not being paid as a CCG, but we have agreed to subsidise some of the costs of the evaluation. For example, we have Ipsos MORI running polls with the public, and we have a range of surveys with patient participation groups to ensure that Dame Fiona is able to evaluate the degree to which people were informed. We have agreed to bear those costs centrally, and I can provide an accounting for that.

Rosie Cooper

You said “some of the costs”. Are you going to meet the costs, or some of them?

Tim Kelsey

Some of the costs.

Rosie Cooper

So patients in CCGs will be contributing roughly how much?

Tim Kelsey

GP practices have existing legal obligations, as we have discussed, to do certain types of fair processing. For example, we are not subsidising them to speak to their patients. We are subsidising aspects of this in order to test it. We are contributing to or paying for the cost of letters to go to each patient and the evaluation that surrounds that. We are also paying for other points of evaluation which we have agreed with the CCGs.

Rosie Cooper

While I appreciate that, can you give us any rough figures? What would a CCG be contributing to this?

Tim Kelsey

I cannot answer that question, but we will very rapidly come back to you with the CCGs’ own estimates of the costs of the programme and how much of that cost is being met by the programme.

Chair

I have been asked to clarify something. The three are Blackburn with Darwen, West Hampshire and all of Leeds.

Tim Kelsey

Yes. There are seven CCGs in four geographic areas, so it is the three CCGs in Leeds; it is Blackburn with Darwen, West Hampshire and Somerset.

Chair

Which of these three pathfinder areas are the ones where so far you have 80 practices signed up?

Tim Kelsey

They are in the West Hampshire, Somerset and Blackburn with Darwen areas. Leeds is developing some proposals which it wants to test with its GPs first, so it has not yet started the recruitment process.

Valerie Vaz

I am a bit confused. You are running a pilot but you do not know what the costs are.

Tim Kelsey

I know what the costs of the central programme are. I don’t know what the costs are—

Valerie Vaz

No. At the pathfinders you do not know what their costs are. You just said you would write to us and tell us about it, but surely you must have put a bid out to someone—the Secretary of State or NHS England—and said, “This is what the pathfinders are going to cost.” What is the cost of that?

Tim Kelsey

Yes, I can give you that. I know what the cost to the programme is for the pathfinder phase.

Valerie Vaz

Presumably, it covers the letters.

Tim Kelsey

It does not cover all the costs such as the opportunity costs for training of GPs and the CCG.

Valerie Vaz

But why not? Presumably, it is a pathfinder and you must have a project in mind. You must have in mind the amount of money you want to spend on it. You are saying you are subsidising the CCGs. You must know how much it is going to cost.

Tim Kelsey

I do know. I know exactly how much it is going to cost for—

Valerie Vaz

But you just said you did not know.

Tim Kelsey

I thought I was being asked about the total cost to the local NHS of fair processing in relation to care.data. I can tell you the costs that are being provided by NHS England, but individual CCGs are additionally spending, or local GP practices are engaging in costed activity, in order to meet the fair processing requirement.

Valerie Vaz

Which you have just said you are subsidising.

Tim Kelsey

Not all of them, because for some of them it is a legal responsibility.

Valerie Vaz

Not all of them but some.

Tim Kelsey

Yes.

Valerie Vaz

So you must know what the costs are of the “some”.

Tim Kelsey

Yes, I do know the costs of some.

Valerie Vaz

Why are you not doing it all, if you are asking them to do something? I just find this horrifying. Is that how NHS England operate? They do not know how much things cost.

Tim Kelsey

Okay, to be clear, I know how much the programme costs from the care.data perspective, but an individual GP has an existing legal responsibility to fair process consents or opt-outs with local patients. That is part of their existing responsibility, so when the care.data programme initiates we are not, as it were, recruiting staff to help them do that.

Valerie Vaz

I am talking about the pathfinders and the project you are trying to evaluate. You must know how much it is going to cost and how much you will subsidise people to find out this information, and how much the evaluation is going to cost. You must have said to someone in NHS England that the whole project is going to cost such and such. Who signs the cheque for that? Someone must have written that off or someone must be signing it off.

Tim Kelsey

Yes. We have a programme budget for care.data, and I can provide you with all the details of that; absolutely.

Valerie Vaz

And the pathfinders in particular, because that is what we are asking about.

Tim Kelsey

Yes, and the costs to—

Valerie Vaz

Mr Kelsey, there is a confusion about whether you are or are not subsidising. You say that you are helping some CCGs but then you are saying you are not really helping them; they are doing it themselves. You will pay for the postage but not something else; you are paying for the training but not other things. We need a bit of clarity, please.

Tim Kelsey

Sure; as I say, I will provide that.

Rosie Cooper

What would make this pathfinder project attractive to a CCG? You say that by osmosis they found out about it and are throwing themselves at your door to do it, and you are not paying for it all. It is going to be at some cost to them. What is it about the pathfinder process that would make a CCG want to be involved?

Tim Kelsey

Perhaps I may read a statement from Sarah Schofield, chairman of West Hampshire CCG. Her message to the Committee, understanding that that would be a legitimate question for it today, is: “Whilst the sharing of patient information across the NHS helps to ensure that the quality and safety of services is consistent and provides valuable insight on diseases and conditions, it is essential that this is done in an appropriate and secure way. We are therefore extremely pleased to have the opportunity to work with our patients to test communications on care.data and ensure GPs are equipped to manage this locally and are able to support patients with making informed choices.”

Rosie Cooper

She would prefer to do that rather than put money into some procedure or other that patients could direct. What would make a CCG want to contribute money to your project? If you told them they were going to do it, I could understand. They are volunteering to be part of it in principle, but they are not benefiting; you are suggesting that it is going to cost them, so why would they do it?

Tim Kelsey

They very much hope to benefit, because as commissioners of services—

Rosie Cooper

But all the other CCGs who are not pathfinders and are not doing it will get the benefit of whatever comes out of this and it will not have cost them any money, time, effort or whatever. I cannot understand what the hook is that would attract them to it.

Tim Kelsey

Hopefully, it was communicated to them to such a degree. Perhaps the Committee needs to sit down with the CCG chairs, but the truth is that commissioners and GPs want to get data to flow in the NHS safely and as quickly as possible, in a sense, to enable them to make better decisions to improve care for their patients. These pathfinders have volunteered and have self-selected; they have gone through a relatively arduous process, so we can defend the selection of the CCGs, in order to educate themselves as to how best this should happen. It is an experiment. It is not my project, nor is it NHS England’s project; it is a project of seven CCGs and four regions in which 250 GP practices want to learn how best to do this, and meet the new standard Dame Fiona has set in relation to fair processing for patients.

Chair

The impression from the letter you have read out is that they want to do it for the greater good.

Tim Kelsey

Yes.

Barbara Keeley

A point of clarity is needed. You said you were not aware how many GP practices in Leeds wanted to opt in or not opt out because it is developing its own proposals that it wants to test. Is that something extra?

Tim Kelsey

I said at the beginning that the premise behind the redesign of the entire programme has been around co-production and co-creation with local front-line services. Each of the CCGs has developed variations with different communities—some are rural; some are urban—on the kind of strategy they think would be appropriate as GPs to meet their obligations, with support from NHS England. As a city, Leeds wants to test some digital solutions for giving people granular opportunities to opt out, so it is developing those proposals with the GP community. It has not yet got to the point where it is recruiting GPs to test out those proposals. It will do so over the next few weeks, and we will be very happy to keep you updated on the process of their selection.

Barbara Keeley

The GP practices in Leeds and elsewhere can opt out, if they want to.

Tim Kelsey

Yes; it is entirely voluntary.

Barbara Keeley

That was not clear. There was a stage in all of this when it seemed that pressure would be put on GP practices if they did try to opt out.

Tim Kelsey

To be clear, in the pathfinder stage this is a voluntary exercise to test the new approach to communicating the opt‑out rights to patients. GPs are not being forced to participate at all.

Barbara Keeley

The question I have—I do not know how easy it is to answer it—is precisely what you want to learn from the pathfinders. I must have mentioned before in all of this that I used to work in IT. We had leading-edge customers who would always want to test things. It does not test something absolutely where you have really keen people who self-select. That is not the acid test, is it, because for the ones who do not want to be first but last in the queue and are not very keen on this it is not going to work as well? I am sure you will learn something from them, but I have to say I am uncomfortable with that process. I would be more comfortable with it if you had offered other areas chances, because there is always a danger in working only with the leading edge. Can you tell us what you do want to learn from the pathfinders?

Tim Kelsey

This is why I really welcome the report from Dame Fiona. That set out some very clear standards that need to be achieved by the local NHS properly to explain both the opt‑out rights we are providing to patients and the learning we need to get from the first pathfinder phase. There may be more. There is no artificial deadline for national roll-out. We just do not know what happens next, but this pathfinder phase is intended to test the degree to which Dame Fiona and her colleagues in IIGOP feel that we are achieving, have achieved, or need to do more to achieve, a proper standard of fair processing. Those are the 27 recommendations, and they need to be achieved and independently assessed. That is the purpose of the pathfinder stage.

Barbara Keeley

Is the plan to use the data extracted in any way in the pathfinders in planning health and social care, or are they simply testing the process? Is it just communications, the leaflet, opt‑out, how it works with GPs and so on?

Tim Kelsey

There are two parts. The first is, indeed, to test the quality of fair processing against the standards set by Dame Fiona. The second part, which the care.data advisory group and others are very keen we also do—Sam mentioned this in his earlier evidence—is that in the extraction of the data from this limited number of practices, which will be held in a totally locked-down secure environment, as I think you are aware, we should run some analytics over them to demonstrate there is actual value in the data as well. Therefore, on the one hand, there is evaluation of fair processing, but, on the other hand, we have already constructed an independent expert group who will look at the outputs of the data analysis and confirm whether or not the hypothesis, or evidence that says linking the data can support improvements in the quality of local service, is to some extent evidenced.

Barbara Keeley

Is it only for that, or is there any intention or plan to get into commercial end users?

Tim Kelsey

No.

Barbara Keeley

Absolutely nothing.

Tim Kelsey

No.

Barbara Keeley

How is that guaranteed?

Tim Kelsey

It is guaranteed because the data will be held. There will be no access to data that flow from the pathfinder practices, other than in the secure data environment. There will be researchers, who are identified already, I think, from only three organisations: NHS England; the Health and Social Care Information Centre; and PHE—Public Health England.

Rosie Cooper

In previous comments we have talked about attempts to communicate with patients being a low point. I suppose that was where I came into it. Have the communications with patients for the pathfinder areas been finalised? Are they going to be different in those different areas?

Tim Kelsey

I was reassured to hear some of the comments made earlier. We feel we have done an enormous amount of co-production with GPs, voluntary groups, Healthwatch and various others to develop the materials. To get it on the record, more than 3,000 people in 180 workshops across the country have helped us to develop these areas. In the CCG areas that are pathfinders, they have also been running their own independent engagement with voluntary organisations, patient advocate groups and so on. Collectively, we feel that with the CCG partners we have got the materials to a place which is unrecognisably better than the previous place we were in, but part of the pathfinder test will be to establish that that is measurably the case. If we need to improve them further, we will do so.

Rosie Cooper

Short-circuiting it, a version of that answer is that, yes, you have developed it and you have got to them. Has the Independent Information Governance Oversight Panel seen those proposed communications, and what is its view?

Dame Fiona Caldicott

We saw some back in November/December, but we understand that even further refinement is happening. We have not yet seen the further refinement.

Rosie Cooper

What was your opinion of it?

Dame Fiona Caldicott

It was certainly better and clearer, but still lacking the sort of clarity we would like to see. It is quite a complicated thing to explain to the average member of the public, dare I say? This is not simple; it is not quite like explaining, for instance, the issue of consent to a procedure; it is more complex than that. There is quite a challenge facing those who are preparing the material to get it absolutely clear what the patients are being asked to agree to or opt out of. There has certainly been progress through the meetings that Mr Kelsey describes. What we saw before Christmas was better, but we think it could be better still.

Tim Kelsey

I hope that over time this Committee will recognise the steps we have taken. One particular aspect of this, as well as the broader issue, was accessibility for disabled groups. I have here a list, which perhaps I can make available subsequently, of all the organisations that have been involved in helping us shape the materials for specific interest groups and constituencies in order that we can help GPs to discharge the responsibility we have to the entire community, not just to those who are able-bodied or able to read.

Rosie Cooper

It is a really difficult thing. I opted out, as you know. I totally approve of this project. I am absolutely 100% behind the principles, but the way it has been handled is an absolute disgrace. I do not need to go into that again. I have opted out. When I looked at medConfidential’s advice on the various levels of opting out and our exchanges at previous Committee hearings, it absolutely confirmed that I did do that. I would like to go on and ask what has been done to make the process of registering an objection transparent and straightforward. Are you trying different forms of wording?

Tim Kelsey

Yes.

Rosie Cooper

I would then like to go on to the impact of that after.

Tim Kelsey

We have done an enormous amount of testing of the wording for the opt‑out. I mentioned that as well. The individual CCGs have tested it with all sorts of constituents. We are now very close to resolving a form of words which appears to be both very accessible and explains simply what the opt‑out now is. It was not just a matter of communication; it was also a matter of fundamentally changing what the opt‑out meant. In the previous situation with this programme there were two layers of opt‑out. There is now just one opt‑out, and the opt‑out means that no identifiable data will leave the GP practice at all and transfer to the information centre, which makes the job of explaining it much more straightforward. That is a very important part of the evaluation of the pathfinder phase in relation to fair processing, where people felt they did understand and were informed by the form of words we used, and also simplification of the opt‑out that has now been decided upon.

Rosie Cooper

That is very good news and takes the onion down to its most meaningful level. It is now one level of opt‑out. What does that actually mean for my care and treatment? In previous panels you have suggested that the GP would not get paid; he would not be part of reviewing screening programmes. If I opt out, what will happen to my care?

Tim Kelsey

To be absolutely clear, there will be no impact at all upon your eligibility or entitlement to treatment on the NHS. In so far as clinicians are exchanging data for that treatment, this has no impact on it at all, so direct care is in no way affected if you choose to opt out of care.data at all. The opt‑out of care.data relates to the secondary use, as we sometimes call it, of data for analysis to support the improvement of quality in local services and, as Nicola said, benefits in research territories. The chief medical officer would argue—many others do—that in the longer term, if large numbers of people opt out, it will impact on the ability of the NHS to improve the quality of care provided, and in that sense it could affect your care in the future, but it in no way affects the treatment you will receive on the NHS if you choose to opt out.

Rosie Cooper

That is really very good news. Are you consulting patients before you roll out these plans in the pathfinder areas? Are patients going to be involved sooner rather than later?

Tim Kelsey

The CCGs and local GPs are working as local consortiums with a large number of different sorts of voluntary organisations. To some extent it is dependent on where they are, but all of them are working with their local Healthwatch. One criterion for the selection of CCGs was that there was a good, active local Healthwatch that could properly represent the views of local communities. Patients are fundamentally involved in the way the process has been designed.

Rosie Cooper

Healthwatch is new, and I would not have thought you could say it has a great reach into communities right now.

Tim Kelsey

I think it varies. Some are very effective, and my own experience of the pathfinder areas and Healthwatches involved there is that both are very active. People are working under considerable resource constraints, but they are very active and committed to try to get this right. I think that the partnership that has been developed in response to the decision to stop the programme last year has been a very good demonstration of the way in which local health communities are getting together for the right reasons.

Rosie Cooper

Could you explain to me exactly what that patient engagement via Healthwatch means? It is a nice flowing sentence, but what is actually going on on the ground?

Tim Kelsey

A lot. I am wondering whether or not we should arrange for the Committee to come and see a pathfinder and talk directly to those involved. They are very active. I am just trying to find the right page for West Hampshire.

Dame Fiona Caldicott

While Tim is doing that, last autumn I had a meeting in our locality, not a pathfinder locality, to discuss the care.data programme. Healthwatch for Oxfordshire was very active in getting together 200 of the local public to come and debate the issues. As is being said, there is tremendous variation, and if it is an active team running Healthwatch it can be done.

Rosie Cooper

Absolutely. That is the reason for the follow‑up question to find out what is going on and what has happened in those areas.

Tim Kelsey

In West Hampshire CCG there have been 16 meetings since October involving all 51 GP practices, patient participation groups, Healthwatch, the local medical committee, CCG boards and internal staff in order explicitly to develop the materials and strategy. It has been a consensus-based approach.

Rosie Cooper

Mr Kelsey, they are all the usual suspects. Where is the public?

Tim Kelsey

The patient participation groups for each GP practice are there to represent the public. Those are the independent bodies which all practices now have to have. It is perhaps a question for the CCGs in a way.

Rosie Cooper

It is self-selecting again.

Tim Kelsey

I do not think so. Most patient participation groups are relatively representative of the local community.

Rosie Cooper

It might be one or two people. I am engaged in health; I was chair of a hospital and all the rest of it. I could not tell you who the patient representatives are at my GP practices. They do not communicate with me. I am a member of the public. How do I know?

Tim Kelsey

All I can say is that when I have been to practices and have engaged with patient participation groups, who are contractually required to exist under the GP contract, they have been very robust.