Official Report: Minutes of Evidence

The Chairperson (Ms Maeve McLaughlin): You are all very welcome. We have with us Dr Ken Macdonald, who is the Assistant Information Commissioner; Ms Rachael Gallagher, who is a senior policy officer in the Information Commissioner's Office (ICO); Dr John Knape, head of communications policy and marketing at the Royal College of Nursing; and Dr Stephen Moore, who is a consultant psychiatrist from the Royal College of Psychiatrists. I advise members that Dr Macdonald has to leave by 3.30 pm. I ask members to bear that in mind. You are very welcome to the meeting. I ask you to make your presentations, and we will open it up to questions and observations after that. I am not sure who is going first. Don't be shy.

Dr John Knape (Royal College of Nursing): Good afternoon. The Royal College of Nursing thanks the Committee for the opportunity to submit oral evidence on the Health and Social Care (Control of Data Processing) Bill. This evidence builds on and substantiates our previous written evidence, submitted in August. It also reflects our response to the Department's consultation on the proposal to introduce primary legislation for the use of Health and Social Care (HSC) service user identifiable information for secondary purposes in controlled circumstances. A consultation was conducted in 2014.

The RCN accepts the need to establish robust and proportionate arrangements that will achieve the correct balance between, on the one hand, upholding the absolute security of personal confidential information relating to Health and Social Care service users and, on the other, the need to ensure that service developments are accurately informed by a strong evidence base. As such, the RCN welcomes the intention to establish a more robust legislative arrangement for decision-making to enable a greater level of assurance to the organisation and the individual and to mitigate the risk of successful challenge. The RCN endorses, in general terms, the need to control how and when the information of service users locally may be accessed to permit the limited use of user-identifiable information for secondary purposes in controlled circumstances where clear and significant improvements to patient and client care can be expected.

The remainder of the submission addresses the specific issues of concern to the RCN. It should be noted that the RCN is offering this submission in its capacity as a trade union and a professional organisation for nurses; we do not claim to offer an expert legal opinion on the Bill and its implications.

In relation to the control of information of a relevant person, the RCN shares the misgivings expressed by members of the Committee at the evidence session on 17 June 2015 about the inclusion of the phrase "in the public interest" at clause 1(1)(b). The RCN agrees that that phrase may be too comprehensive and non-specific in scope and could potentially leave the system open to abuse on the basis of a broad and/or subjective interpretation of what may be in the public interest. The RCN notes that the former Health Minister sought to address that issue during the Assembly debate on 29 June 2015 and that he indicated that the Bill is designed to permit, rather than require, sharing of information. The RCN also notes the explanation provided by departmental officials on 17 June 2015 in relation to the potential use of data by, for example, the Northern Ireland Fire and Rescue Service. However, we do not find that explanation convincing. The legislation should apply purely for the purpose defined in clause 1(1)(a), and the RCN recommends that clause 1(1)(b) be excised.

With regard to the establishment of a committee to authorise the processing of confidential information, the key issue is establishing appropriate safeguards to ensure compliance with the legislation and the safeguarding of personal information. The RCN is unclear about how the proposed committee would discharge that function. The 2014 consultation document stated:

It is not clear why or how the advisory group that is proposed in the consultation document has now evolved into the committee that is proposed in the Bill. More importantly, the defined purpose of the advisory group is to protect the security and interest of the service-user from the non-authorised use of personal data. The wording in the Bill, however, states that the purpose of the proposed committee lies in:

It may well be that the proposed committee's functions will mirror those of the advisory group. However, if that is the case, it is not readily apparent from the wording in the Bill. There appears to have been a subtle change of emphasis from protecting the interest and security of the service user to ensuring compliance with the legislation. These two objectives should be synonymous, but may not always be so.

The RCN is, therefore, concerned to note the admission by departmental officials during the 17 June evidence session that the proposed committee could override the decision of an individual to opt out from the disclosure of data by using the public-interest criterion. Although there was some discussion of that matter between members of the Committee and departmental officials, the matter was not resolved during that evidence session. The RCN urges the Committee to seek further clarification on this issue.

While arrangements relating to the membership of the proposed committee are to be defined in regulations, the RCN believes that, to command public confidence, it is important that the proposed committee must be truly independent and its composition, constitution and outlook should exclude anyone with a vested interest — personal or professional — in accessing personal confidential data. It should act as a guarantor of compliance with the legislation and an advocate for the rights of service users in this respect.

The RCN has no specific comments on the wordings of the clauses of the proposed legislation that relate to a code of practice, regulations, interpretation, the short title and commencement. In conclusion, the RCN's primary concern and, we suspect, for service users and the wider public in Northern Ireland in relation to the Bill, will be to ensure that any personal confidential information accessed is done so securely and for purposes that are genuinely related to the commissioning and provision of healthcare services, rather than for any commercial activities. It will be essential for the Department to build confidence in this principle and overcome some of the negative perceptions and doubts that have built up as a consequence of the sometimes indifferent track record of HSC organisations in respect of their capacity to manage and store confidential personal data securely.

Stakeholder and public support for the Bill will largely be determined by an understanding of the controls that exist around the access and use of information, and the general feeling that the Bill's primary purpose is to protect the security of confidential personal data, rather than facilitate access to it. These controls relate to the security and confidentiality of the data, the fact that it must not be used to an individual's detriment in identifiable form, as the result of research conducted at the level of the group, or in relation to any potential commercial access to data. The RCN, therefore, welcomes the wording of paragraphs 8 and 9 in the explanatory and financial memorandum.

I hope that this oral evidence has been helpful to the Committee, and I reiterate the gratitude of the Royal College of Nursing for the opportunity to present it today. Thank you.

The Chairperson (Ms Maeve McLaughlin): Thank you. We will take all of the commentary from you and open it up. If members want to direct questions to a particular organisation, they can make that clear.

Dr Ken Macdonald (Information Commissioner's Office): Thanks very much for the invitation to provide evidence on the Bill. The Information Commissioner's Office, as you will know, is the UK-wide authority for the regulation of the Data Protection Act 1998, and our key interest in the Bill and your considerations is the compliance with the Act and how it fits etc. We have advised the Department on a number of initiatives in the past, for example the Honest Broker Service, which allows anonymisation and pseudonymisation for research purposes.

When we started considering the Bill, we had a fairly major concern that it would contravene the Northern Ireland Act in view of the fact that data protection is a reserved matter. There is no problem at all with the Assembly legislating for the sharing and processing of information, but it seemed to us at first that this was introducing something called a "condition for processing", which is well established in schedules 2 and 3 to the Data Protection Act (DPA). However, we spoke to officials in the Department and they reassured us that they had spoken to Westminster and are satisfied that the Bill conforms and that there is no danger of intrusion into a reserved matter. That gives us comfort. If it had intruded, there would be a question of legality.

Our general concern about the Bill as it stands is that it is somewhat overarching and very broad-brush. It is, however, in the nature of what you are proposing, and the detail will be in the accompanying regulations. I suspect that we will have far more comment on the regulations than on the Bill itself. However, we are reassured that a code of practice will be developed, and, as is our practice, we will work with the Department to ensure compliance with the Act.

We welcome the fact that the Bill puts the disclosure of the information on a statutory basis. It helps organisations to comply where there is a statutory ground. It also makes the processing by them easier for us to regulate, and it is much clearer for them to fit with that regulation. The big danger is in relation to the requirement under the Data Protection Act that processing be fair and lawful. This addresses the requirement to be lawful, but our concerns are with the fairness of the process. John has alluded to that in his comments. Patients need to know what is happening or is likely to happen to their information. There needs to be proper guidance and proper awareness-raising activity at the stage of implementation and when patient information is being collected. That requirement is far more stringent in the case of sensitive personal data, and medical health information, whether physical or mental, is a category of sensitive personal information. The Act requires much more information to be provided to the patient at the point of collection about the purposes of collection and how it may be processed, both with and without their consent.
Again, this comes up at the later stages of the implementation of the proposals. It is key for the success of what you propose that you build, and officials build, public confidence in the way that the information is used. I know you have alluded in previous sessions to what happened in England and some of the difficulties experienced there.

Like John, we have concerns about the breadth of clause 1(1), and we think that it should be reconsidered and strengthened. Public interest is a concept that we are familiar with — it is in the Data Protection Act — but it is too easy to bend one way or another. If you can narrow clause 1(1) down by making it more prescriptive, that would be beneficial.

Finally, there is the code of practice that will be prepared and published. Essential to the whole programme is the delivery of training and awareness-raising to the practitioners — the people who tend to the patients and use the data. The whole gamut of people who have access to patient information need to be aware of what is required to treat it securely and safely and avoid the reputational damage that health bodies have sustained because of carelessness in processing, as John mentioned.

Dr Stephen Moore (Royal College of Psychiatrists in Northern Ireland): Thank you very much for the invitation. A lot of the things that I will say have been said just now and by Professor McClelland and Dr Harper in their evidence session, so I apologise for the repetition.

The college thinks that this is very important legislation. Many of the things that it enables in law are already happening. It is important that we enshrine them in law in a supportive and robust framework. I am talking about things like disease registries.

In our evidence, the college discussed concern both that there would be scope for compulsion in terms of forcing people to reveal information, which has been echoed again today, and that the public interest provision in clause 1 is slightly too broad. However, I listened to the Law Centre's evidence from Dr Harper, and it said that it has to be in the public interest for provision of health and social care, which narrows it considerably and eliminates some of what we had expressed concern about in our evidence. I note that other people have felt similarly about that. Indeed, there are some uses by other organisations such as the PSNI that would fall within providing for people's health and social care. There are court diversion schemes where, if the police are aware that somebody has a mental illness, or that somebody has diabetes and their blood sugar may be dropping, their awareness of people's mental or physical health could be beneficial to those people in that moment.

I agree with the view expressed by Professor McClelland that there are very few compelling secondary uses of data outside use for research or for establishing disease registries to allow us to look at how best to develop services. For instance, there is an example given in the initial consultation document about giving people with cancer an additional winter fuel payment, which initially feels fairly innocuous. However, it is quite a paternalistic thing to do to say that people with cancer will take an extra winter fuel payment and that we cannot find out who they are and write to them to ask whether they want it but will just give it to them. There is a secondary consequence of this that did not appear to be considered. The person's bank manager will see all the people who are getting £150 and could quite quickly work out who has cancer, regardless of whether those people want that information to be revealed. There are issues around inadvertently releasing information into the public domain about people that, at first glance, appears to be entirely in their best interests.

Another example that happens in Northern Ireland is that the Regulation and Quality Improvement Authority (RQIA) supervises the use of electroconvulsive therapy across the Province. As part of that, the psychiatrists administering it have to give them a return every month including the names, dates of birth and hospital details of any people having that treatment, and whether they are having it voluntarily or under mental health legislation. That is the sort of arrangement that this legislation would protect and support. It is the sort of arrangement that is important because we use it for audit and for monitoring the appropriateness of the use of the treatment.

I agree that it is vital that a committee is established. I reiterate that it is not just the case that a committee "may" be established, as it says in the Bill, but that a committee must be established to monitor and appropriately approve use of information. It was suggested in our evidence that the committee should sit within the Department rather than within the universities, for instance. I reiterate that. I also suggest that input from service users or patients, medics and laypeople would be very important to give that committee credibility, although, on the other hand, you do not want the committee to become so large that it is unwieldy.

There was a point made in the BMA's evidence and that has been made today by my colleagues beside me that, with compulsory release of information, there is a risk that people could effectively be prosecuted for refusing to release people's private information. I realise that the Department has said that that is not what this is for. However, right now, the legislation does allow for a committee, or indeed just the legislation itself, to force the release of people's information. The college does not feel that that would be appropriate at this time.

My last point goes back to what I said earlier about the sometimes unintended consequences of release of people's information. The General Medical Council has advice for doctors on the use of the internet and social media. It talks about how little pieces of information that we give over time can eventually add up to breaching patient confidentiality and how it is very important that whatever information manages to make it into the public domain from this does not inadvertently breach confidentiality on issues that people would not want to have released.

That is everything that I have to add to our written evidence. Thank you very much again.

The Chairperson (Ms Maeve McLaughlin): Thank you all for that detail. I seem to be hearing that it is important legislation and that, obviously, it is important to get the legislation right but there are similar concerns in relation to the fact that it is very broad in its definition, particularly in and around public interest. That is a message that we have continued to raise and which we are hearing as we progress. Specifically, if clauses 1(1)(a) and 1(1)(b) were removed and the legislation referred to only:

— would that be clear enough?

Dr Moore: Clause 1(1)(a) probably needs to stand. There is a danger with clause 1(1) that, if you remove clauses 1(1)(a) and 1(1)(b), it reads as if it is authorising primary use of information but not secondary use, and primary use is already fine. Clause 1(1)(a) is saying that the use of the information is to improve health and social care. That makes it clear that the remit of use of the information is outside use specifically for the benefit of the relevant person.

The Chairperson (Ms Maeve McLaughlin): Clause 1(1)(a) could become part of the paragraph above, but clause 1(1)(b), which concerns the public interest, from your perspective, could go.

Dr Moore: Yes.

Ms Rachael Gallagher (Information Commissioner's Office): From the First Reading of the Bill up to the point where gave written evidence, it seemed to suggest that it was in the interests of improving health or social care or the public interest. In discussions with the Department, it has since been clarified that it must be for medical or social care purposes that are in the public interest. It is more a case of restructuring the clause slightly to make that more explicit because, understandably, it will lead to misinterpretation.

The Chairperson (Ms Maeve McLaughlin): OK. Is there a similar view from the College of Nursing?

Dr Knape: Yes. Certainly, we would support the retention of the phrase, "in the interests of improving health and social care", but we recommend the excision of the phrase, "in the public interest". If the Committee feels that, somehow, it has become too convoluted and that the whole paragraph needs to be reworded, we would support that. The word "or" is perhaps the key; that leaves the door open for the ambiguous interpretation of what may be in the public interest.

We did not specifically mention this in our evidence, but we also recommend replacing the word "medical" with "health" because there are many legitimate health purposes that would not necessarily fall within a medical framework in the sense that "medical" is traditionally understood by the wider population.

The Chairperson (Ms Maeve McLaughlin): Just to be clear, what I hear from all three of you is that a reworking of that provision that would very clearly identify that "public interest" specifically relates to health and social care is needed.

Dr Knape: The RCN would support that.

Dr Macdonald: There is a danger that, if you delete clause 1(1)(a) and (b), you are actually making it wider by just saying:

That opens it up to everything. Our preference is paragraph (a) and (b), rather than (a) or (b).

The Chairperson (Ms Maeve McLaughlin): In relation to your remit, Dr Macdonald, the Department commented on the concerns in your written evidence. You touched on some of this, but, in relation to compliance with first and second data protection principles, it stated that the Bill does not set aside the requirements of the Data Protection Act 1998. Again, you touched on this: any processing must fully comply with the provisions of the Data Protection Act, and it will be the responsibility of the requester to evidence to the committee that that is the case. Does that address your concerns?

Dr Macdonald: We were never in doubt that the concept of the Bill would be in compliance. We had the concern that what you were proposing would be better sat within the Data Protection Act rather than as a separate piece of legislation by the Assembly. It looked as though you were creating one of these new conditions for processing, and the condition for processing in terms of the Act can be set only by Westminster, either by amending the Act or through statutory instrument. The Department has gone back to the Westminster Departments to ensure that they are happy that this is within the competence of the Northern Ireland Assembly. It is not for us as the regulator to make that judgement but for you to take the legal advice on it. We are satisfied that, in general, this is going to comply but the devil is going to be in the detail of the regulations that follow. I think we would have to have substantial input into those.

The Chairperson (Ms Maeve McLaughlin): In general, there is compliance, but, again, a lot of this will be through the regulations and code of practice.

Ms Gallagher: The Department is introducing this to plug the gap in defending itself against legal challenge should the common law of confidentiality be said to be breached, which would, in turn, be unlawful. That in itself would breach the first data protection principle, which requires information to be lawfully processed. In effect, this legislation is addressing the first principle of the Act as well, so it is also in keeping with the DPA. We welcome that.

The Chairperson (Ms Maeve McLaughlin): The Department has responded to concerns raised in relation to opt-out provision. Its intention is to provide opt-out arrangements in the regulations. Do you believe that, if opt-out provision is of such importance, it should be in the Bill?

Dr Macdonald: I would be happy enough with it in regulation. One issue, though, is that any individual can change their choice at any point. You can consent to processing and withdraw consent. You can refuse processing and then give the consent later. It is important for it to be appreciated that consent given at one point in time may not apply a year later, maybe even six months later. So, there will have to be provision at some point, whether through the code of practice or through the regulations, to limit the period over which that consent is valid.

For example, some data is processed and research is based on it within, say, 12 months of giving the consent. However, we really have to think about it again if it exceeds a given period, because the patient may well have changed their mind in the process. That argument is going on in a different sector altogether at the moment in terms of marketing by charities, which has been hitting the headlines again today. People may have given consent many years ago but then find that their information is being processed in ways that they never expected at that point. This is a completely different situation in that we are talking about sensitive health information, but the principle itself remains: consent can be withdrawn, and lack of consent can be changed.

The Chairperson (Ms Maeve McLaughlin): There is also the issue of fundamental protections. Public confidence is important. When we look at what happened in England and the failure of the opt-out processes, we see that there is a strong case to be made for it to be in the Bill.

Dr Macdonald: That decision has to be taken by you, but the point has to be respected.

The Chairperson (Ms Maeve McLaughlin): OK. Are there other views on the opt-out issue?

Dr Knape: We certainly support the view that the detail of the opt-out arrangement, as Ken suggested, should be in the subordinate legislation or code of practice. However, we feel quite strongly that the initial reference should come in the primary legislation. That would help to remove some of the ambiguity around the issue.

There is a fundamental principle that, if the drafting of the primary legislation is not right because there are different interpretations or Ministers are required to stand in the Assembly and explain themselves, clearly something is not right because there should not be that fundamental ambiguity in the first place. We think that it would help to build public confidence and a sense of clarity about the intention and scope of the legislation if we could make sure that the wording of the Bill is absolutely watertight.

The Chairperson (Ms Maeve McLaughlin): OK, thank you for that.

Dr Moore: To some extent, whether the opt-out is enshrined in the code of practice or in the legislation, while it is important, is a red herring. So much of it is about ensuring that there is the technology to back up the opt-out. The care.data problem in England occurred because they wrote to everybody in England saying, "Let us know if you want to opt out". Seven hundred thousand people wrote in and said, "We would like to opt out". They had not thought about opt-outs until the very last minute, and there was no robust technological solution for tracking who had opted out or for ensuring that the opt-outs were respected. In fact, the opt-outs were effectively a tick box in the system, as I understand it, that did not do anything. It is important that whatever system we have to track whether people have opted out feeds in to ensure that the data does not get released when it should not. It is important that that is considered early and that the technology is backed up early, rather than them saying, "We will build that in at some point".

Mrs Dobson: Thank you for your briefing. My first question is for Dr Macdonald. In your letter you talk about a number of aspects that you feel require consideration, and you talk about engaging with the public about the secondary use of their data. Could you perhaps explain and outline a bit more how you see that engagement taking place to ensure that the Data Protection Act is not breached?

Dr Macdonald: This comes back to the fairness of processing, which Rachael and I mentioned. It is one of the principle requirements: there should be fair and lawful processing. That fairness can be done in many ways. It is about publicity or getting the message across to patients, whether through media, posters in doctors' surgeries and other mechanisms such as social media, etc. It is about keeping alive in the individual's mind what might happen to their information and the purposes for it. It is absolutely imperative that the public have the confidence that the data will be used as they were told and that, importantly, it will be used and stored securely.

I will refer back to Stephen's point about the care.data system not being robust enough. We recommend that, at some point in the development process — again, this can be put into regulation — what we call a privacy impact assessment is undertaken of any system that is being put into place to implement the Bill and the research. A privacy impact assessment looks at the system in its entirety, tries to identify where the weaknesses are, such as where there may be potential for information being disclosed or mishandled, and puts in mitigating factors to counteract that. Of course, it also involves testing the systems: if that system programme had been tested before it went live, we might not have had that issue.

Mrs Dobson: It is quite alarming to hear that it was a simple tick box with no testing, yet 750,000 people, I think you said, Stephen, asked to opt out. That is frightening, and I share your concerns about the broad phrase "public interest" and the interpretation of it.

I have a quick question for John. Again, your briefing uses the phrase "public interest", and your body is one of the many that has raised those concerns. I note from your briefing that you are not convinced by the Department about the Fire and Rescue Service. Can you explain that for us in a bit more detail?

Dr Knape: That is based on the official transcripts of that evidence session. I note that departmental officials tried to use the Northern Ireland Fire and Rescue Service as an example of where the sharing of data might be justifiable in the public interest but may not have a direct health and social care purpose. We were simply noting that, without further information about what those circumstances might be, we found that explanation unconvincing. That was an attempt to suggest that something could be somehow in the public interest yet, within the context of the legislation, not be directly related to health and social care. We were really unclear about what that purpose might be.

Mrs Dobson: OK. I just wondered specifically why the Fire and Rescue Service was —

Dr Knape: I was citing that example simply because departmental officials cited it, I think to try to illustrate how — this is in relation to clause 1 and the issues we were discussing — there could be a situation where something might be "in the public interest" but not necessarily directly related to health and social care. We were simply saying that, without any further context to that, we found that explanation unconvincing.

Dr Macdonald: We have spoken to the Fire and Rescue Service about some of the work that it has been doing on the protection of vulnerable people. One of the examples is that somebody may be sick at home and dependent on an oxygen supply. There is a huge fire risk because that oxygen supply is there. If a fire did take place in their house, there would be a risk to the fire officers in attendance. There is a public interest in the Fire Service being aware that those hazards are in that particular building, which it has to take account of in attending a fire. I think that would fit the strict interpretation of clause 1(1)(b), because the information would be passed in the public interest in that way.

Mrs Dobson: Finally, John, you said that your primary concern with the Bill was on the use of personal and confidential information solely for healthcare purposes, rather than, as you say, for commercial activities. Can you outline a bit more your concerns about the potential commercial aspect of it?

Dr Knape: There are various scenarios that I am sure we could all imagine where commercial organisations would dearly love to gain access to confidential information, whether it is in relation to insurance, for example, or perhaps the provision of private medical services. We note that the former Minister, when he spoke on the issue in the Assembly, was reasonably categorical that it was something that he would be particularly alert to and that the Bill was in no way designed to facilitate access in this way. We were simply putting down a marker, if you like, that that was something to be considered carefully not only in the consideration of the legislation but in any future activities relating to the code and the activities of the Committee.

Mr McKinney: I suppose we all recognise the importance of moving towards something like this, and the issue is about ensuring maximum safeguards and protecting interests. To that end, I favour the RCN's description of the principles protecting the security of confidential data, rather than facilitating access to it — albeit facilitating access to it, but the principle is about protecting. In that sense, safeguards are important. The opt-out, safeguards and regulations have been touched on by the Chair, but those are in relation not only to the opt-out but to the committee. It may, by regulations, establish a committee. Should that not also be in the Bill? I would like you all to reflect on that.

Dr Macdonald: I do not think that is something that the ICO has a view on. It is not particularly about the processing of the information itself; it is a mechanism that you are considering would be valuable there. It has its role, but we do not have a specific view on that.

Dr Knape: We would simply advocate that the wording in the Bill reflect its role in preserving the security of information.

I mentioned in my evidence that there appeared to be a subtle change of emphasis in the wording as it now appears compared with the wording in the original departmental consultation last year. Again, it may just be a question of tweaking the wording to make sure that it is absolutely crystal clear that the primary function of that committee is security, rather than facilitating access.

Dr Moore: In our initial written evidence, in the paragraph above the summary and conclusion, we say:

So, yes. [Laughter.]

Mr McKinney: Thank you very much. Is anybody surprised? Obviously, we are dealing with it here, but the fact is that 700,000 people in the rest of the UK, when confronted with this, opted out. They wanted to opt out. In your mind, is there any consideration that we should give, given that tangible evidence that people chose to opt out? Should we not pay attention to the weight of that body of evidence, which was that those who are attending hospitals for secondary purposes are choosing to opt out?

Dr Moore: If I may? There was discussion about this at the session that Professor McClelland attended, so I did quite a lot of reading about the care.data opt out and what happened. Dr Harper's estimate of how many people it would be was about 5 per 500,000, so 700,000 people across England and Wales opting out is in the ballpark of that. It is 1·2% instead of 1%, but it is about what would be expected. The other side of it is that, when care.data came through, it was substantially different in its aims to this legislation. The legislation already exists in England for secondary uses.

Care.data was the pooling of people's healthcare information. It was the sucking of their data out of GP and hospital systems into a centralised system, the idea then being that other organisations, including the private sector, could access it. It was designed so that uses for NHS purposes would allow, if necessary, the use of identifiable information. Uses for things like insurance purposes would, if necessary, go for pseudonymised or anonymised information, rather than having access to patients' names. Uses for things like public audit would be open because they would be completely anonymised and would just give over all the statistical data.

That being said, the press got hold of this and the care.data information and proceeded to scaremonger by saying, "All your information is going to be sold to health insurance companies and life insurers so that they can charge you more money." That whipped up a fair body of people who may not have normally opted out but who chose to opt out on the basis of having less useful information than might otherwise have been given to them. On top of that, there are people who will opt out of any information gathering. So that percentage of opt-outs is not off-scale from what would be expected.

That being said, what this attempts to do in Northern Ireland is to simply ensure that we can provide the same level of care that is provided through research and by attempting to improve public health in a way that is already available in England. I think that while, yes, 700,000 people is a big number, it is not a big number in terms of the population of England and Wales compared with what they would expect.

Mr McKinney: Of course, it would not be the overall population; it is only those who —

Dr Moore: — heard about it and chose to opt out. That is true.

Mr McKinney: So, it is a bigger figure out of that; those accessing —

Dr Moore: I think, on balance, what it is trying to do is at least worth trying to do.

Mr McKinney: And addressing concerns, by doing the safeguards.

Dr Moore: Absolutely.

Mr McKinney: Mr Macdonald, you said that we should emphasise that engaging with the public on the secondary use of their health and social care data is essential. Has there been sufficient engagement with the public?

Dr Macdonald: I think it is possibly still at an early stage, and really, there are two —

Mr McKinney: Is that a no?

Dr Macdonald: No. There are two phases, I would say. There is the engagement prior to the drafting of the Bill and its publication. Of course, there was the consultation that took place around this time last year. Then there is the phase when it is being implemented. That is really the crucial part. It comes back to what Stephen said about things were taken up by the media, twisted and scaremongered. As he suggested, I think that the figures were inflated because of the way it was reported in the press. I have seen elsewhere, such as in Scotland, the same thing happening, where a government proposal — it was related very vaguely to healthcare — for administrative data from our NHS central register in Scotland was going to be made available to other bodies. But the press was highlighting that as open access to health records.

Mr McKinney: I can understand how the press might take something on, but the responsibility is for those who are bringing in legislation to engage properly.

Dr Macdonald: Absolutely.

Mr McKinney: Has that happened?

Dr Macdonald: They have undertaken their consultation here. I cannot say whether it was at the appropriate level. What I wanted to come to —

Mr McKinney: I will let you get there in a second, but I want to interrogate this. You are emphasising that engaging with the public on this is essential. Should you not satisfy yourself that that, in fact, has happened?

Dr Macdonald: The Bill has gone through the usual stages and the usual consultation process, which is one that is well established. Our real focus is on the implementation stage and where the information is being gathered. Once this is set in law and once the regulations —

Mr McKinney: Could I just clear this point up? Is this the consultation about the making of the legislation? You have jumped to the point when it is in. The public are concerned now and, like us, need to be able to have as big a voice as possible about the moulding of it. Is that robust enough?

Dr Macdonald: All I can say is that the consultation has gone through the standard procedures. I am not aware of the ICO ever having said, "You have not done the appropriate consultation at the Bill stage".

Mr McKinney: Yes, but you said that it is essential. You emphasised that engaging with the public is essential. This is your point; it is not my point, although I agree with it. Given the interrogation of this issue, I think that we are agreeing that this is not any normal piece of legislation. There is a move forward or sideways or a different approach being taken, and there have been concerns in England. Are the Northern Ireland public receiving enough information? Are they being engaged with to the essential level that you propose?

Ms Gallagher: That is a question for the Department to answer.

Mr McKinney: Of course.

Ms Gallagher: I emphasise as well that the process is not over yet and that there is still ample opportunity for the Department to engage with the public at that level.

Mr McKinney: Are you aware of its plans to do that?

Ms Gallagher: We, as a regulator, would not be, because our opinion is based on the Bill as we see it. That is very much for the Department to undertake. However, there are numerous opportunities ahead of it on this.

I take your point that, to get a piece of legislation that has public buy-in — there is definitely a very high level of public interest in this — the Department should undertake those exercises. However, the process is not over yet, and the Department has assured us that it will have a robust handling strategy in the implementation of this legislation or in any subsequent regulations that come under this primary legislation. It is not a question for us —

Mr McKinney: It is and it is not. You are here, you are looking at it, you asses it and you monitor, etc. Anyway, I have made the point; I do not think we will stretch it much further. You made the point that it is essential. I suppose that it is up to us to make sure that higher level is there, given the proposed legislation. Sorry, you were going to make a final point.

Dr Macdonald: I was saying that there is effectively this stage and the implementation stage. It is really the implementation stage, once the data is about to be gathered, that the ICO's regulatory role comes in, because the Data Protection Act is about information that has been processed. There is no information being processed at the moment, so we do not have a regulator's view on the awareness raising on this consultation. Once it is being processed, we must be satisfied that the public know what is happening. That will be through all the different types of channels that I mentioned before, but very specifically at the point of collection where the individual is in a position to give their consent.

Mr McKinney: John, obviously yours is a local body but also very much a national body. Has there been input from your colleagues on how it has or has not worked there?

Dr Knape: Not specifically. I had some general conversations with colleagues at a UK level. Given that this is a Northern Ireland-specific piece of legislation, we have tried to embody some of the principles that they set out while reflecting those purely in the Northern Ireland context.

One of the issues that came across from that discussion and that I think is important is that this is not simply an issue between, on the one hand, the public of Northern Ireland — patients and clients — and, on the other hand, those who seek access to the information. There are also people in the middle. In our case, those are front-line nurses, and obviously the organisations representing other colleagues would make the point about the people they represent. This relates to your previous question, but very often they are the people who are the first port of call for patients, clients, relatives and carers who may have questions and concerns about this. We think it is very important that any engagement process needs to embrace front-line staff.

It is important to remember that the security of patient and client information is a very important ethical principle for all regulated health and social care professionals. It is something that is enshrined in their code of conduct. It is something that, if transgressed, can call into question their registration. It is also something that nurses take very seriously. We are concerned that the Department and others who are responsible for the legislation engage with front-line staff — in our case, nurses — to make sure that they are aware of the implications of the legislation so that they can be advocates, if you like, for the legislation with the patients and clients whom they are here to serve.

Mr McKinney: One point, if I may, Chair. Stephen, you touched on the stigma issue with particular diseases: is that something that you could elaborate on?

Dr Moore: First, can I extend that answer a little bit?

Mr McKinney: Yes.

Dr Moore: I am on the medical informatics committee in the Royal College of Psychiatrists, which is a UK-wide committee. I have had conversations with colleagues in England about how the roll-out of care.data went. During the last informatics committee meeting I was at, they talked about a thing in England called the summary care record (SCR). The Committee is probably familiar with the electronic care record (ECR) in Northern Ireland. They presented to me and to everybody what the summary care record would be capable of doing. All the people from England went, "That is very good", and I went, "But we have that, and we have better. We can see X-ray results. We can see blood results. I can see people when they attend out of hours. I can see clinic letters. I can see anything that I would need to see about a patient. Why doesn't yours do that?". They said, "Oh, we had that. We were ready to go with that, and then the care.data stuff happened". That affected not just care.data; public confidence in the health and social care informatics as a whole plummeted. They were told, "There is no political will to let you do this. Do something that you can do within your own systems, and do not link anything up".

At the minute, we have a much better, much more robust patient electronic care record in Northern Ireland than they do in England. Every day since it has come in, more and more people tell me, "This is brilliant. This is actually changing our practice. We can get results quicker. We can connect with each other quicker. It's doing wonders". I would worry that, if we lose the public's confidence on this, ECR will fall back to being what SCR is in England now. At the minute, it is something really very good, and we need to protect it. Sorry, that was a digression.

Yes, on the stigma stuff, I would be — I was going to say, "I would be", which is not true — I have colleagues in the forensic setting and in the addiction setting who have expressed concerns to me, saying, "If people know that our patients have been in contact with forensic services and that information got out, it would be an issue, because that information is really very protected". That is people who have been in trouble with the criminal justice system and who have had a mental illness that has impacted on their offending. If an employer even knew that somebody had been in touch with forensic mental health, that would be enough to potentially upset them. Equally, information on whether people have substance misuse problems, have used illicit substances or have significant alcohol problems would certainly be important for service planning and for providing a good service to the people of Northern Ireland for that. However, again, from the point of view of the service users, if information were to come out that a person has a drink problem and has not had a drink in six months, that could be very damaging to them.

Certainly, we are trying to combat mental health stigma, and I am not sitting here saying that mental health conditions are special and different. They are not; they are health conditions. The other side of it is that patients and service users will come in and say to us, "We feel like they are different. We feel like these are important. We feel like these things have to be kept private". At the same time, on ECR, we are saying, "Actually, we think that the access to this should be wider and that doctors and other specialities should have access to our notes". However, the other side of it is that we would need to be very sure that people were happy with information about that sort of thing being potentially available for release to people conducting research or acting in the public interest. I hope that answered the question.

Mr McKinney: Yes, it does. Thank you.

Ms McCorley: Go raibh maith agat, a Chathaoirligh. Thanks for the presentations. I will go back to the opt-out. Ken, I am referring to the bit in the ICO piece. It says that the Department had noted that, in the consultation, there were concerns about opt-out, and it explained that the proposals will establish a statutory basis that will allow for the sharing of information and will not have the power to require it to be shared. You have pointed out that clause 1(2)(a) says that the regulations may make provision for requiring or authorising the disclosure. That being the case, do you think that, ultimately, there is a 100% opt-out option?

Ms Gallagher: We had that concern originally. Due to the number of concerns that we had, we invited departmental officials to discuss some of them with us. One was definitely the opt-out and how that would work in practice. The Department clarified — and maybe there are grounds for clarifying it in the Bill — that the committee would make a decision on authorising it but that, ultimately, it would be up to the health and social care body holding the information whether to disclose it. There would be no onus that, for example, the information on a patient who had opted out would be disclosed anyway. In other words, the opt-out would be honoured and the information would not be disclosed. The Department has since clarified that matter for us.

Ms McCorley: Do you feel that it is watertight?

Ms Gallagher: The opt-out is not explicitly in the Bill. Again, the devil will be in the detail in the regulations. We will comment further and make sure that those revisions are data protection-compliant at that stage; but, at the minute, the Department has assured us that this will be the case.

Ms McCorley: Stephen, you talked at length about mental health issues and the stigma involved. Whether we like it or not, there seems to be a lingering stigma around mental health issues. How do you feel about the opt-out? Are you satisfied that it would be honoured?

Dr Moore: If the Department is saying that the opt-out will work in the way that we are being told it will, then that is probably reasonable. I remain concerned that the second word in clause 1(2)(a) is "requiring". I almost feel that it should back away from "requiring" and say "authorising".

My understanding, from reading about the issue, is that this is attempting to bring in a different way to say that diseases must be notifiable. It will not be a case of, "We will require everything", but, if there is an outbreak of a serious infective disease in Northern Ireland that is not currently on the notifiable diseases register — something like Ebola — they could then say that anybody who has Ebola has to tell us and that the opt-out will not hold for that. I am not sure that this legislation is the place to do that. There is already a list of notifiable diseases, and maybe there needs to be a mechanism for amending that.

Ms McCorley: OK. Paragraph 8 of the explanatory memorandum states :

It has been highlighted that "health" would be a better word than "medical". It continues:

Do you have concerns about the words "some other tangible benefit"? Are you concerned that that wording is very broad?

Dr Moore: That wording is probably at variance with how the Law Centre analysed it. The Law Centre took it to be that it must be, at the very least, a health and social care reason and that it should also either be for improving health and social care or should be in the public good and related to health and social care. If we take the Law Centre's interpretation, then paragraph 8 is perhaps slightly broader than that because it says:

That feels like it will touch on the Fire and Rescue Service's wish to support people who are vulnerable, which is absolutely understandable, but it could also touch on anything else that it could reasonably argue is a public good. It all seems to run contrary to what people are interpreting the Bill to say now.

Ms McCorley: It seems to be just not robust — anything but.

Dr Knape: The RCN shares your concerns. We certainly read that as an elaboration on the issue we discussed previously with the reference to the public interest.

Ms McCorley: OK, thank you.

Mr Easton: Stephen, you spoke about the make-up of the committee, and that it should be small because the larger it gets, the messier it gets. That is what I think. Do you have numbers in mind and should there be more laypersons on it than those from the Department? What should be its specific make-up in the opinion of all four of you?

Dr Moore: I do not have any specific numbers in mind. Five sounds small enough to be agile but large enough to be representative. I certainly think it should have a reasonable number of laypersons. If you are having five people, you would almost need to have two laypersons, a representative from the Department and, being a doctor, I would argue for two medics. But, it should have two people, one of whom will understand the research implications — so somebody from a university, be it from a social work, nursing or medical background — and somebody from a patient care perspective to look at the likely impact of releasing information on patient care. However, I just made that up. I do not want to sound like a —

Mr Easton: No, it is something that we have to get right. If it is going to be credible, you have to have the right number of people on it.

We were talking about safeguards and we would not want certain information going out to the likes of insurance companies. Should there be something in the Bill to say what information should not be going to different companies? Does that make sense?

Dr Macdonald: We would certainly support clarification on which bodies the information could be disclosed to. Going back to Care.data and its experience, then clearly limiting it to only the public sector would build in public confidence. The public are worried about the use of their information by the private sector. If you want to get buy-in, perhaps that is the way that you will help to achieve that.

Mr Easton: OK.

Dr Moore: A strengthened clause 1(7) might cover that. It states:

And, equally, not making that provision:

To some extent, there is no harm in insurance companies knowing the incidence of an illness in the Province. That would be quite useful to them. Equally, there would probably be no harm in them knowing that it was more prevalent in people over the age of 50. It probably would not be helpful for them to be able identify individual people who had an illness and not disclosed it to them. From that point of view, this is already talking about not using the legislation related to the care and treatment of individual persons.

Sharpening that clause might say that it is OK to use this information to look at population demographics and the health of the Province as a whole but not OK to use it to identify individual people with an illness so that you can then target them. I realise that other groups have given evidence suggesting that they would quite like to do that because they would like to find people with rare diseases and let them know that there are treatments, in case they did not know. There is a risk of throwing the baby out with the bathwater, and it would need to be carefully done.

The Chairperson (Ms Maeve McLaughlin): I thank you all for that. It has been very useful. We will be reflecting on what we heard today. It is useful to hear general consensus, particularly around the definition of public interest and linking that directly with health. Some of the evidence in relation to opt-out and whether it should be in the Bill for clarity is important for us to hear.

I also thank Dr Macdonald for the assessment of fairness in the process. There is an important point in and around public consultation. My understanding is that only five or six individuals have responded to date. Most of them have been from the medical professional background, so there is an issue about learning the lessons from England, because the public consultation process there was poor. As a result, there has been a dent in public confidence. We need to get this right.

I thank you all for your time and expertise. Thank you.