Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 60-78)


26 APRIL 2007

  Q60  MR JACKSON: Thank you. That is very comprehensive. Chairman, could I ask two brief supplementaries? Have you estimated the impact of how many patients might opt out and what impact that would have on their application, and, very briefly, with regard to GPs, are you absolutely sure that there are issues about breach of confidentiality for GPs in the system, albeit inadvertent, and their liability for it?

  Mr Cayton: Let me take the first one first. Of course, these are only provisional figures, but there are 10.5 million people in Scotland in the Scottish system; there have been 593 opt out requests in Scotland, which is 0.01% of the population. In Hampshire and the Isle of Wight system, 690,000 people, 1,050 opt outs, 0.15%. In the Early Adopter Programme so far in Bolton 0.17%, and in the Wirral 0.01%. So, we are talking about less than 1% of the population when people have the system clearly and properly explained to them and they know what is going to happen in practice.

  Mr Granger: Not the big opt out.

  Q61  SANDRA GIDLEY: Excuse me, I live in Hampshire. No-one has clearly explained the system to me. I very rarely go to my GP. How am I supposed to know whether I need to opt out or not?

  Mr Cayton: I will turn to Gillian because she is working on the Early Adopter Programme.

  Dr Braunold: In Hampshire (and it is some time ago) leaflets were sent to the population. I am not responsible for Hampshire, but we have taken some learning and I can take you through how we are not happy to do it the way Hampshire did it, which is where we have been criticised for not listening. We have been listening very carefully to the ERDIP (Electronic Records Development and Implementation Programme) project, which Hampshire has been, which is one of the NHS IA projects on the electronic healthcare record, and they did a mailshot to every household. We have learnt from what Hampshire did, because we believe that it did not go to every person who needed to learn about it, and I have learnt more about the junk mail rule than I ever want to know, but it exists and you need to send to every addressed adult in order for it not to get thrown away if you have got Safeways or Tescos trying to tell somebody something at the same time. Not only are we sending to every address but we are sending to every adult over the age of 16. Originally the Information Commissioner asked us to write to every adult over the age of 18, but my colleagues in Bolton came back to us and said, "But we have got adults between 16 and 18 who do not live at home", home being with their parents, "they live at another registered address." So, we went back to the Information Commissioner and said, "What do we do about that?" and he said, "Okay, you can send to 16 year olds." So we have now sent to the 50,000 patients who are registered with the first nine practices that we have gone with in Bolton. We have written to everybody, not only those who are 16, but everybody who is going to be 16 over the first three months of the pilot, and they have been sent addressed leaflets. But we do not rely just on that leaflet campaign, we have to then do other methods of communication within the area. There have been lots of newspaper articles and other methods of getting into communities that are going on at the moment in Bolton. We have been stuck a bit by purdah. I am being perfectly honest. From March 15 onwards has not been a brilliant time because we are now in purdah, and until May 4 we cannot do much more in terms of a public information programme in Bolton; but the minute we get past the May elections, we are allowed to do something that is being interpreted as political process because of the political nature of this discussion that we are in now, so we will be able to do a much wider advertorial campaign. We are doing information booths and a public information programme within Bolton where people are coming in, for instance, to Lever Chambers and they asking in depth questions. We have sent out around about—. You have got the figures, Harry, of how many leaflets we have sent out to people in Bolton. There have been requests for something like 900 sets of confidentiality packs from the Bolton population from the 50,000 that we sent out and about 400 of those were altogether from people who had various difficulties, and I think about 60 of those have gone to people with limited eyesight—Braille versions and large print—so we know that we are getting there. One fact that you might find interesting is that I thought maybe people were not reading the leaflet. You know, you send a leaflet to people houses. How do we know they read the leaflet? Unfortunately, we got one letter wrong to one practice. It said that they were registered with a different practice. We had hundreds of phone calls from patients who said, "You say I am registered with practice X instead of practice Y." So they were doing some reading of the material that we were sending them. Nevertheless, the whole project is to be evaluated to check, not only the consent model, but the quality of the information programme that we are doing, because the consent model is predicated on informing the population and, if the population is not informed, the consent model is inappropriate. So, we have an independent evaluation that has been commissioned that is starting on 1 May, and that will look at all the different communication methodology that we are using in Bolton, and it is not just an evaluation for Bolton, it is the whole Early Adopter of the summary record in its first year that is being evaluated, and we are testing different methods of communicating with the patients who are being affected.

  Mr Cayton: The Care Record Guarantee is now available in 16 languages, and we are increasing the number of languages as we go. I have brought some examples here if you would like to see them.

  Q62  MR JACKSON: I did not get the second part answered about the concerns that GPs have.

  Dr Braunold: Very briefly, I did 22 road shows with Professor Pringle across the country and we had concerns from GPs around the time taken to consent, which was, I think, the biggest concern that people had. So, what we are doing with my colleagues is looking through the data quality, which is really important, so that they do not inadvertently send erroneous information. We know that the dataset that is being uploaded in bulk is the drugs and allergies. The reason we have chosen that (and it took some discussion with colleagues across the country about going for that model) is because the drugs and the allergies are likely to be the most accurate subset of information. We are all using datasets, formularies, if you like, so it is not free text, and it is very likely to be accurate, whereas the summary of the significant medical history has the potential to be inaccurate, and that is why it is not going in a bulk, it is going opportunistically one by one so that there is the checking of that by the patient and the doctor before it is submitted. Part of the model is that those are only submitted after a conversation with the patient, and how that is being done is being worked through by our colleagues on the ground who are prepared to put that pain in to testing different models and seeing which works the best.

  Q63  Chairman: Thank you for that reassurance, Dr Braunold, that a leaflet delivered through a letterbox is actually read. It is something that some of us have doubted from time to time in this profession. I would like to ask you very quickly what level of consent will be required for the Summary Care Record data for secondary purposes such as clinical research?

  Mr Cayton: The law will not change in any way whatsoever, and the law is clear that patient information can only be used for clinical research with consent or entirely anonymised, or, exceptionally, with the permission of the Patient Information Advisory Group which gives section 60 approval as part of the 2002 Health and Social Care Act. The two grounds on which the Patient Information Advisory Group will give consent, which is obviously a parliamentary matter, is if it is clear that getting consent is either impossible or so onerous that it is not appropriate and the public benefit of the research is so great that it justifies doing the research without getting consent. There will not be any difference whatsoever in the legal position of people's data in terms of research with an electronic system than from now. I am just grabbing this back, this particularly useful piece of paper. To put this in context, Biobank, you will be aware of, has recently started to invite members of the public to take part in research. I have to say I was personally quite sceptical and I have been quite interested by the fact that 10% of the people mailed by Biobank in their pilot in Manchester actually responded positively to the invitation to take part in research, and, although a number of those people (and again I am surprised how few but I think it is interesting) wanted to know how their name and address came to be selected and wanted to know who had sent out their name and address, of the very small number—23 who wanted to know how they had been selected, 25 who wanted to know how their name an address was obtained—after they had had a discussion with Biobank 50% of those people continued to go forward to take part. So, I think what this is suggesting, not in any way that we should move away from consent for research, which I think is very, very important, but that the public in this country still have very strong communal interest in clinical research and in a common ownership of the Health Service, which I think is one of the wonderful qualities of our Health Service, that it is a joint enterprise and not a set of private contracts.

  Q64  DR NAYSMITH: Good morning. Mr Granger, I understand that it is proposed that patients will be able to put some or all of their data into electronic sealed envelopes if they choose to do so, but I also understand that the technology to allow this to happen does not yet exist, is that not rather astonishing?

  Mr Granger: Is it astonishing it did not exist by 2002, or is it astonishing that it does not exist yet?

  Q65  DR NAYSMITH: Is it not astonishing that it does not exist yet? Is it an oversight that we are starting talking about it and yet the technology is not there to do it?

  Mr Granger: No, because the consent model which you have heard about around the Summary Care Record has dealt with whether people would like their information withholding or not and the variety of arrangements there, and I think we circulated some information to you around that. It becomes necessary as we move into segmenting a record with the detailed information that will follow as the system evolves. It is difficult to specify, difficult to develop and it reflects the views of certain groups of patients and certain groups of experts, and I think as we go through the evaluation process with the Early Adopters we will get a better understanding of whether we have got .2% of the population potentially driving a very large amount of expenditure on computer software when 99.8% of the population have a very simple requirement that the NHS treats them as safely and as efficiently as possible. So, I think the sequencing is rational based on the way the programme is going.

  Q66  DR NAYSMITH: When will the sealed envelopes become available? When will that technology be available? Are you saying that it might not if it is such a small proportion that it does not matter?

  Mr Granger: The current proposal is that the Spine central infrastructure software release programme in April, May 2008 will deliver the central functionality for sealed envelopes. I do not wish to mislead the Committee. You must recognise that the systems that feed in and out of a central system will also have to be upgraded to comply with that, and one of the challenges we have is that this is not a requirement in other jurisdictions. We have got a plan to deliver it.

  Q67  DR NAYSMITH: Is it a requirement anywhere else?

  Mr Granger: I am not aware of other—

  Dr Braunold: I think in France there is a sealed envelope functionality. My French is limited, but what I read of a translated grid showed a sealed envelope functionality with the two levels of sensitivity very similar to the one that we have suggested here, and I think some of the delays that Mr Granger was referring to—. We did a risk assessment of the original sealed envelope proposal through our clinical safety arm of Connecting for Health, and it became very evident that we were at risk of breaching the very confidentiality that the sealed envelopes were there to protect if people did not use them properly. So, you have got this balance of business process and the human beings in the NHS who are not used to this new way of thinking that might well not use the software properly when we design sealed envelopes to protect patients' particularly sensitive items. The other risk was that if we did not have the functionality right, then large swathes of the population would opt out because they would have no confidence in the system. By opting out I mean that they would choose not to share their information. We did some work with the technology office and with clinicians around the sealed envelopes proposal that I have given you as a power point, and I am well aware that the Committee is running late and I am very conscious that you probably do not want me to take you through it, but what I would like to say is that we have proposed two levels of sensitivity there, a normal sensitive barrier that would give an audit trail if somebody opened it who did not have express permission to open it, and a sealed and locked version where it is not even visible outside of the work group you are in. We took that to the most challenging group of doctors of all that exist—not just doctors, clinicians I should say—the Sexual Health Conference that the CFH ran last month, who are the most sceptical that the confidential data that they deal with in the GUM clinics will not be adequately protected. We took them through the sealed envelope proposals that we have and how we think it will work and we asked them in the evaluation: "On the basis of what you have heard, would you support your local sexual health service using the NHS Care Record Service? Please scale your answer using (1) not at all to (5) very much." I will submit this as a note, but the evaluation showed that 23.8% were on three, 23.8% were on four and 26.2% on five, and the people who were on not at all or the next grade up were 2.4% for each of those categories. So, we were very, very pleased with that outcome for the most challenging group, that when we explained our proposals for simplifying the sealed envelope structure but making it fit for a purpose, we think that we have got the technical specification right for the service.

  Q68  DR NAYSMITH: You still have not answered my question when you think it will be.

  Dr Braunold: Two thousand and eight.

  Mr Granger: Software drop, April, May 2008.

  Q69  DR NAYSMITH: You are confident you will meet that target?

  Mr Granger: BT have delivered every one of their central software drops on time for the past 18 months. There was lots of delay before that, but this has become quite a reliable delivery environment now.

  Q70  DR NAYSMITH: I understand you also commissioned a risk assessment report last year suggesting that it would be best to hold information like this locally rather than on a central database?

  Dr Braunold: That was the risk assessment process that I was referring to, which looked at how would we use it and were there risks associated with it; and we redrafted it in line with the recommendations of that risk assessment report.

  Q71  DR NAYSMITH: So it does follow that?

  Dr Braunold: Absolutely.

  Q72  DR NAYSMITH: You were talking about the presentation you let us have. On the last page it says that information in sealed envelopes can be pulled off for anonymised secondary user purposes, but SUS information data is not always totally anonymous, is it, because it includes postcodes and date of birth?

  Dr Braunold: That is what pseudonymised is. Pseudonymised, which is one of my most challenging word to spell, means you could get to some part of the demographics without knowing the full name and address of the patient.

  Q73  DR NAYSMITH: But someone can find the full name and address of the patient from date of birth and postcode information?

  Mr Cayton: I would just repeat the point. There is no difference in the legality or in both professional and legal frameworks. This is a process of clinical research now and there are very, very strict guidelines. My view is that because of the audit trail, for instance, and some of the other securities that lie within the system, the new system should actually allow better use of fully anonymised data. I should say, there is a secondary uses working group of the Care Record Development Board which will report in the next month or so, and that group contains a large range of both patients representing sensitive issues, such as mental health and HIV, and researchers and clinicians. It is chaired by Sir Robert Boyd and I am looking forward to receiving their report which will have a number of suggestions, I think, to even further increase the safety and security of the use of records for clinical research, which I think we all want to achieve because it is in all our interests to continue to do clinical research, including on mental health and HIV.

  Q74  Chairman: I think we are down to the last question, and I would like to ask it of you, Mr Granger. We have had a number of submissions that you will be amazed to know about that say there should be an independent technical review of the national programme. How do you respond to this?

  Mr Granger: I am interested as to whether the people calling for that are, indeed, themselves independent. We have been as a programme the subject of significant scrutiny, both from the NAO and the Office of Government Commerce and a number of reviews which we have commissioned as a consequence of events or concerns that have occurred over time. Ministers took a decision last year that there was no benefit in a further review of the programme being undertaken, and that was the position that was set out by Lord Norman Warner in the spring of last year.

  Q75  Chairman: A technical review is a bit different to reviewing all the issues that are floating around in the media quite a lot of the time. Is that your understanding in terms of overruns? Would it seek to get answers to questions that some people believe remain unanswered.

  Mr Granger: We know from 350,000 people using systems that did not exist four years ago with billions of pieces of information flying around the network that did not exist, with hundreds of thousands of people using a security framework that did not exist. At what point do we get to a situation where people's research tool, which is Google, is actually thrown out? They would not go shopping for health advice on Google, but they somehow consider that they can vicariously analyse the performance of a programme using generally inaccurate press coverage. I am not sure. Do we have to get to 500,000 users? This programme was always going to be very challenging; it has been very challenging; it will continue to be very challenging. Where there is specific expertise that is going to work from an evidence base and improve what we are doing, reduce errors, reduce time overruns, I would say with the time overruns that one of the problems with this programme is there was no financial contingency. So, as a programme director, quality, functionality and time are the three things that we have to deal with and the only expression of dealing with problems on this programme is necessarily time, because we are operating within a financial cap and the functionality demands have tended to increase rather than decrease. If there are people who want to work from an evidence base, the door has always been open for them to come and work with us, but people who just lob cold collations of negative media coverage in so-called dossiers hardly do themselves a service as a serious group of people that are working from a robust evidence base.

  Q76  Chairman: They and others around could influence public opinion about this problem.

  Mr Granger: Undoubtedly they do.

  Q77  Chairman: Would such a review increase, or be likely to increase, public confidence in the programme?

  Mr Cayton: Might I just come in there and say that it seems to me that—. I have always said that the Care Records Development Board deals with the issues to which there is no right or wrong answer, only the best answer we can come up with. If there was clearly a right answer to some of these difficult issues, then we would not need committees and we would not need inquiries to look at them. It is only because they are, inevitably, contested issues, both in ethical terms, in terms of good clinical practice and in terms of the functionality of IT systems in the modern world. My feeling is that, through the systems we have got in place, there is a very robust system now of involvement and engagement through the Care Record Development Board and the National Clinical Leads and a large amount of public scrutiny, which I welcome, because I think the kind of scrutiny this Committee gives is part of a proper process of examination of what the programme is doing, we have to move forward on that basis. If we keep going back and saying, "Because I disagree with a decision that has been reached through a public and accountable process, I now want to unpick everything", we will never deliver and the people who will, I think, not forgive us are our children, who live in an IT enabled world now and, I have to say, will be very surprised if in 50 years' time we are saying to them, or perhaps not us, but our children's children are saying to them, "Oh, we gave up because it was too difficult."

  Q78  Jim Dowd: Given the scale of the undertaking, as you have described it, given the novelty of a lot of the approaches, how much of your system's software is dot zero releases in the operating systems that are out there?

  Mr Granger: None of the operating systems, because they are either industry standard proprietary systems or LINUX. In terms of the application software, almost all of the applications that are being delivered are systems that have been deployed extensively previously or are incremental upgrades of things which were deployed previously. In terms of the core Spine infrastructure, there was some mythology in the Health Informatics Community that the standards existed, HL7 was mature, and so forth. That was completely untrue. We have had to put an awful lot of effort into specifying the standards for messages, around demographics, around booking, around prescriptions, and then the software that BT have built with a number of sub-contractors is brand new software that has been custom-built for the NHS; so that is high-risk, new build software. There was no other way of doing it. I am very pleased a number of other jurisdictions are getting very interested in using that. What I do not want us to end up with in the NHS is a situation we have in a number of other areas of civil administration where we expend a significant amount of money building something which, when it comes up for re-tender, we have a unique supplier and we either have to pay to get other people to come in and bid in order to have a competition for the replacement, or we are held to ransom at the point of replacement. What we need to get to is a sufficiency of open standards, which we are leading a lot of jurisdictions on, so that when we come to re-tender these systems at the end of the contract there is a vibrant market of suppliers in a number of jurisdictions and we do not face that risk on an enduring basis because we are sharing software that is used in other places. I think, in particular, the Welsh Assembly will have some very interesting choices when we turn off the systems on which they are dependent, starting next year, as to whether they use the English solution or they go and build from scratch something that does the same thing.

  Chairman: Could I thank the three of you very much indeed for coming along. I am sorry about the overrun in this session. I thought it was likely to happen in view of the inquiry. Thank you very much, again for coming along, and I hopefully it will not be too long before we have our report out in relation to the Electronic Patient Record.

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