3The ‘safe space’ (the prohibition on disclosure)
Introduction
45.In this chapter, we explain what is referred to as the ‘safe space’, which is the prohibition on disclosure of information in the draft Bill, and we consider:
- what outcome the Government hopes to achieve, whether it is what patients want, and whether the ‘safe space’ is likely to help;
- possible side-effects of having this;
- the material which is, or ought to be, protected by the ‘safe space’;
- exceptions to the prohibition, i.e. what ought to be disclosable from within the ‘safe space’;
- how such disclosed information and HSSIB reports can be used for such purposes as evidence before the courts, or for disciplinary purposes; and
- how the draft Bill will interact with data protection legislation.
46.The proposal that NHS trusts be ‘accredited’ to conduct ‘safe space’ investigations is addressed in Chapter 4. In the draft Bill as it stands, references are to HSSIB or an accredited trust. In the light of our recommendation in Chapter 4 that NHS trusts should not be accredited to conduct ‘safe space’ investigations, in this chapter we refer only to HSSIB.61
47.The term ‘safe space’ is not used in the draft Bill, but is widely understood to mean the prohibition, in clauses 28 to 30, of “the disclosure of any information, document, equipment or other item held by the HSSIB […] in connection with an investigation, apart from in certain limited circumstances”.62 It is designed, the Government says, to “encourage NHS staff and other medical professionals to speak freely during the course of an investigation in the knowledge that information they provide will not be passed on” unless an exception applies.63 The draft Bill also provides for exceptions to this prohibition, which are listed in clause 29. They allow for disclosure to the police, to various NHS bodies, or to professional regulators, in defined circumstances. We examine these below.
Box 3: Expert Advisory Group recommendations: ‘safe space’
The Expert Advisory Group proposed that information should not—generally—be disclosed by the HSIB. It said that a bar on disclosure of information and its use in court would “underpin a just culture that ensures the continued provision of safety information and the confidence of healthcare professionals”.64
The group made the following recommendations of direct relevance to the issue of ‘safe space’:
9. The Branch must provide families and patients with all relevant information relating to their care, reflecting the responsibilities of healthcare providers to uphold the duty of candour. To ensure the continued provision of safety information and the confidence of healthcare professionals, all other evidence collected solely for the purposes of safety investigation will be protected and will not be passed to any other body or be admissible as part of another body’s proceedings, other than when required on the instruction of a court of law.
10. Safety information must be provided to investigators honestly and openly in the understanding that it will not be used inappropriately. However, hiding or interfering with evidence is unacceptable and should be made an offence. Similarly, when safety investigations uncover indications of wrongdoing, negligence, unlawful activity or other concerns that constitute an immediate danger to present or future patients, the Branch must inform the relevant responsible body and/or regulator, who may undertake their own inquiry and remedial action.
The Expert Advisory Group thought legislation should “give powers to compel organisations and individuals to participate” in investigations and share information in a timely fashion, and that it should be an offence to conceal or tamper with evidence.65 It also concluded HSIB should notify relevant authorities where it identified concerns that might endanger future patients.66
Justification for the ‘safe space’ (the prohibition on disclosure)
The desired outcome
48.William Vineall, Director, Acute Care and Policy at the Department of Health and Social Care (DHSC), explained that, “in having a pretty sealed safe space, we will be able to produce reports that get to the bottom of things in the way that the NHS isn’t able to at the moment.”67 But there is a tension, which we explore later, between maintaining confidentiality in order to get to the truth and sharing information with patients, so we were particularly keen to try to understand what patients themselves want.
49.Some patients, and patient representative organisations, told us that lessons should be learnt to avoid repetition of mistakes. Susanna Stanford, who suffered an immensely painful and traumatic incident as a mother undergoing a caesarean section, told us:
Like so many patients who seek answers, I was desperate that other patients should not experience a similar situation if it could be avoided.68
and
‘Safe space’ is vital for clinicians to be able to trust the system and it should help achieve what most patients want when they complain: simply that learning can take place so the same error is not repeated with someone else.69
50.A mother told us in harrowing detail about the painful death of her 14-year-old daughter following surgery in 2015. Her view was that:
Although a duty of candour had been introduced in 2014 the process, certainly in my experience in 2015, was that the system worked against showing any candour. A safe space would encourage people to speak honestly …70
51.We note that it is important to understand that some patients may not want their patient information to be shared with their families or others.
52.John Tingle, Associate Professor at Nottingham Law School, Nottingham Trent University, told us: “Often patients just want an apology, an explanation of what occurred and an assurance that it will not happen again.”71 The Equality and Human Rights Commission thought it important that there be “a presumption of disclosure in the investigation report of all information necessary to ensure that the patient and/or their family understands why the incident occurred and the steps which are required to ensure that similar incidents do not happen in the future.”72
53.We nevertheless recognise and have taken into consideration the strong and natural desire on the part of patients to obtain all information possible about treatment—investigations ultimately are all about what has happened to them—and to seek justice. The Association of Personal Injury Lawyers thought that a ‘safe space’ might lead to necessary information not being obtained before proceedings were started:
negligent failings may not come to light. A case that should be pursued may not be, leading to a denial of access to justice, and a failure to bring those responsible for the negligence to account.73
As AvMA told us, “there is nothing ‘unfair’ about injured patients seeking compensation for harm caused, and NHS staff are not personally liable as the NHS takes vicarious liability”.74
54.We are persuaded by patients, and their representative organisations, that there is nothing unreasonable about injured patients seeking compensation or other redress. Therefore, this Bill and HSSIB should place nothing in the way of patients and their families’ ability to seek compensation. The importance of this principle is reflected in the recommendations we make.
55.We also have been guided by a second principle, namely that the primary and overriding purpose of this Bill is to put in place arrangements that will lead to learning and improvement arising from objective and comprehensive analysis of the causes of clinical mistakes and incidents, leading to better and safer outcomes for users of the healthcare system. We do not think this second principle is incompatible with obtaining justice in individual cases, which may and should be pursued by other means.
56.It is in the wider public interest, and in the interest of patients and everyone in healthcare, that procedures be pursued that will assist in improving patient safety. Subject to the reservations set out below, we are therefore supportive of the proposal to provide for ‘safe space’.
Likelihood of achieving the desired outcome
57.Most of our witnesses considered providing a ‘safe space’ to be an effective way of eliciting all the information necessary to learn lessons and improve patient safety. NHS Providers referred to “a wide body of research” supporting this conclusion.75 Dr Simon Fleming said:
You cannot learn unless you are in a safe space. Anywhere there is a fear of recrimination or of your own reflections being used against you, by definition people will not reflect. You cannot ask people to talk openly and honestly about their experiences, knowing that that will then immediately be visited upon them.76
The Patients Association suggested that the consequences experienced by some who had raised concerns provided “ample justification for those fears” and concluded that it was right to try the new approach of ‘safe space’ during HSSIB investigations.77
58.The Nursing and Midwifery Council (NMC) explained how their views had changed:
although our initial response to these regulations was very much aligned with the PSA’s and we were concerned that by creating a safe space we might, as regulators, be regarded as an unsafe space, we recognise that this middle stage that HSSIB can develop probably needs to happen. It should then become a model for good investigation. Eventually, we can almost remove the safe space boundary because people will feel confident that, if they say to HSSIB that they did something wrong, we as the NMC will then recognise that nothing will happen to them because they showed insight, remediation; they don’t need regulatory action.78
59.Pharmacist Nick Butler told us: “the pressure for the recent change in the law decriminalising dispensing errors made by some pharmacy staff demonstrates how the risk of prosecution affects what individuals will disclose.”79 The Royal College of Midwives thought the prohibition on disclosure will reassure patients, families and staff, “particularly where concerns about fear or reprisals from management can prevent someone from speaking out on patient safety issues.”80
60.By contrast, Solicitors Mills & Reeve LLP thought the ‘safe space’, as drafted, will be ineffective because the “risk of criminal liability and regulatory referral will still result in individuals being wary of speaking freely.”81 The Royal College of Physicians and Surgeons of Glasgow gave similar evidence82 And the Campaign for Freedom of Information cast doubt on the provision’s efficacy:
The exceptions rightly permit information about misconduct or continuing risk to patients to be passed to professional regulatory bodies or NHS employers who can suspend, strike off or dismiss a health professional. To the health professional who fears that they or a colleague may have made a serious mistake, the consequences of the permitted disclosures are likely to be a far greater deterrent to frank admission, than any concern about a possible FOI disclosure.83
61.AvMA suggested there was no need to prohibit disclosure of information from investigations to patients:
no evidence has been put forward to show that staff are not […] taking part in investigations because of the fear of their evidence being shared with key parties such as the patient or family concerned, or of unfair consequences being experienced by someone who has given evidence to an investigation as a result of this being shared with the patient or family concerned.
We believe it is true to say that some staff are anxious about taking part in investigations fully and frankly. However, we have canvassed health professionals widely and when asked what they are worried about, it is almost always the case that they are worried about how they will be treated by their boss/employer.84
The PSA also thought that “although concerns about personal repercussions, for example risk of litigation or effect on career do figure, there are a range of other factors which appear to be at least as important if not more so.”85
62.In the Committee’s view, Professor Murray Anderson-Wallace, and his fellow independent members of the HSIB Advisory Panel, captured the position neatly:
A legally protected ‘safe space’ in healthcare is as yet completely untested and it is therefore impossible to say with absolute certainty if this will promote greater learning to improve safety. Speaking freely and feeling confident to be honest is a product of a healthy and just workplace culture, where learning and accountability are well balanced. This type of culture does not exist in too many healthcare environments and much work needs to be done to foster it.86
63.The experience in other safety critical industries is that ‘safe space’ investigations will encourage professionals to be more open with investigators, but only time will tell how effective this will be in the healthcare sector. The ‘safe space’ approach is based on a better understanding of what people feel when they are under scrutiny. It also supports patients who do not want their information shared more widely. Although initially only introduced on a limited scale, this approach is an innovation for the healthcare sector which presents great possibility for positive evolution of the attitudes and behaviour people have tended to adopt towards patient safety incident investigations.
Other justification
64.Another possible justification for providing ‘safe space’, albeit not one the Government believes it has incorporated into the Bill, is compulsion of witnesses. This is discussed in Chapter 6.
Other perceived effects of the ‘safe space’
On patients
65.Several witnesses expressed concern that information currently available to patients and their families would in future be kept from them, both by accredited trusts and by HSSIB, because of the legal requirement to respect the ‘safe space’.87 Professor Brian Toft told us:
One of my problems with safe space is that people may not believe they are getting justice because they cannot have access to the data that is being used to derive the report.88
and
It is very personal to them, and they want to know, generally speaking; in fact, in some cases they want more than that—they want to see somebody put in jail.89
66.The Association of Personal Injury Lawyers was concerned that a ‘safe space’ could mean necessary information about negligent failings not coming to light, “leading to a denial of access to justice, and a failure to bring those responsible for the negligence to account”.90
67.These accounts quite understandably focus on blame rather than learning. Matthew McGrath, of DAC Beachcroft LLP, observed that:
If certain material is not disclosable, prima facie under the Act, it will invariably—and I am sure you have heard from those who act on behalf of claimants—create a suspicion among patients that they are not being told the full story.91
However, he countered that much information will still be available and said: “it is in the interests of the public to see that there is still a lot of information that is potentially disclosable”.92 The Clinical Human Factors Group told us that any protection in the draft Bill will not alter the information patients can obtain.93
68.The information and material to which the prohibition would apply is in addition to any information or material to which access currently exists. It would not change the legal status of any information that would exist or continue to be acquired outside a ‘safe space’ investigation. Only HSSIB would be prohibited from disclosing the material or information from its ‘safe space’.94 It would consist only of information or material created by, or given to, HSSIB, and only while held by HSSIB. The prohibition would include, as the NMC pointed out, all the information generated during an HSSIB investigation, for example transcripts, witness statements and recordings.95 But it would not, it seems to us, apply to documents or other information already in existence and held by others. These would be unavailable from HSSIB (unless already in the public domain), but would remain available from whoever holds them, as they are now.
69.Assuming the Government accepts our recommendation regarding the accreditation of trusts, nothing about the ‘safe space’ would prevent patients (or regulators, the police, or the public) from acquiring anything to which they currently have access. We are absolutely clear that the sole purpose of the ‘safe space’ is to facilitate gathering evidence for HSSIB’s ‘no-blame’ investigations. It does not interfere with any other investigation or inquiry procedure which already exists.
70.The Patients Association were concerned that as a result of ‘safe space’, patients will not discover what had happened to them:
In NHS trust investigations into patient complaints and serious incidents, the full findings must be made available to the patient and/or their family members (if, for instance, the patient has died). It cannot be acceptable for these investigations to identify what happened to a patient, but then be barred from telling the patient or their family what has been discovered.96
71.But Scott Morrish, whose son Sam tragically died in avoidable circumstances, thought a family will be told what had happened:
The expectation, and my hope for HSSIB doing a good job, would be that it would then include everything that is relevant in its final report, and thereby it will come back to the family. The family is benefiting from this as much as everybody else.97
72.Patients will not be supplied with the new evidence that HSSIB will obtain or compile. That is not the purpose of HSSIB. But we expect HSSIB to provide sufficient detail in its reports for patients and their families to understand, in clear terms: what happened, what went wrong, why, and what should be done to make sure it does not happen again. In our view, this is the purpose of HSSIB. At the same time, we recognise that some patients may not wish their information or testimony to be shared with others.
73.AvMA was concerned that, because HSSIB will be prohibited from sharing information connected with an inquiry, patients will be unable to “challenge erroneous evidence provided”, resulting in “poorer investigations and less learning”.98 Nevertheless, we are reassured that the draft Bill will require HSSIB, before it publishes a report, to send a draft of the report to everyone who participated in the investigation, and to notify them that they have the opportunity to comment on the draft.
74.The Patients Association suggested it might be desirable “to mandate the HSSIB to develop a programme of patient engagement, both to inform how safe space will be used and to develop information to provide clarity and reassurance to patients and families”.99 We discuss elsewhere the intended resources of HSSIB;100 it is enough here to note that they are currently intended to be modest.
75.We agree with The Patients Association that it will be very helpful to engage with patients to help them better understand what ‘safe space’ means, why it is important, and how such investigations will be conducted. It is not clear to us whether HSSIB will have the resources to sustain this important role, which is vital for patient and public confidence in HSSIB. We recommend that the Department for Health and Social Care and HSSIB engage with patients and families, and their advocates or representatives, to ensure that the ‘safe space’ is widely understood by them.
On the duty of candour
76.We considered in Chapter 2 the effect that the duty of candour has had on culture in healthcare. The healthcare sector is subject to two such obligations to reveal what has happened when things go wrong.
a)There is a professional duty of candour to which healthcare professionals are subject by their regulators.101
b)There is also a legal duty, imposed on health and social care providers and managers,102 and enforced by the CQC, to tell people when they could have been harmed.103 The provider (or manager) must explain, truthfully, all they know about the incident, what further enquiries are appropriate, and the results of those enquiries. They must also include an immediate apology, and a written apology.
The professional duty of candour
77.Some of our witnesses suggested that the ‘safe space’ non-disclosure requirements might prevent practitioners from complying with their professional duty of candour. The PSA’s Harry Cayton told us, for example, there was a danger of creating:
both for health professionals and for patients, [the] dilemma of, ‘What do I disclose openly under my duty of candour? Do I withhold some information because there is going to be a safe space investigation? Do I withhold all the information because there is going to be a safe space investigation?’ […]
I think there is a duty of confidentiality once a safe space investigation has commenced. Does that apply to patients who give evidence within that framework? Can they not repeat their evidence in public?104
78.The Campaign for Freedom of Information thought the prohibition will also apply to information supplied by any patients, family members or staff, even those who were willing for their information to be made public.105
79.Consistently with the Government’s fact sheet on ‘safe space’,106 Jennifer Benjamin explained this was not the case.107 Scott Morrish told us the argument that ‘safe space’ will drive “a coach and horses through the duty of candour” was “little more than scare-mongering”.108 DAC Beachcroft LLP confirmed that the Bill “does not restrict what clinicians may disclose to patients about information provided to the HSSIB”, though there will be no positive duty on professionals to share with patients everything said to HSSIB.109 Clause 28 prohibits disclosure by HSSIB (or an accredited trust conducting a ‘safe space’ investigation) only.110
80.While the evidence of the effect of the duty of candour on changing the culture in the NHS may be mixed, we believe it is contributing to positive change. It is clear that HSSIB, and only HSSIB, is prevented from disclosing information under the draft Bill’s prohibition on disclosure (clause 28). The healthcare professional’s duty of candour is not diluted by the ‘safe space’ in any way. Nor would other contributors to an investigation, such as patients, be barred from sharing with others the evidence they gave to HSSIB.
The statutory duty of candour
81.AvMA made a compelling case that information now shared with patients by providers in accordance with their statutory duty of candour will have to be withheld if a trust were conducting an internal ‘safe space’ investigation. Peter Walsh explained:
if you have a safe space investigation, the information goes into a black hole. If the trust has that information before the investigation, they are under a statutory obligation to share it with the patient and the family. If you create a safe space investigation, it becomes a black hole.111
82.This concern was echoed by the PSA, the Campaign for Freedom of Information, the Patients Association and the CQC.112 The National Guardian’s Office (NGO) pointed out it could affect information shared with the NGO when conducting a case review.113
83.It would not be right for this draft Bill to restrict information which is freely available at present and, in respect of HSSIB investigations, it does not do so. HSSIB’s purpose is not to provide a hiding place for uncomfortable truths, but—in the interests of patient safety—to provide the greatest possible assurance that its investigations will have no negative consequence for participants. We look at accreditation in Chapter 4, but this provides an initial, and compelling, reason why we do not support the accreditation of trusts to conduct ‘safe space’ investigations.
Relationship with duties of NHS trusts and other bodies
84.NHS Providers emphasised to us that NHS trusts have a range of duties to comply with when things go wrong. They referred to duties relating to employment, duties to ensure good standards of care, and statutory duties to liaise with police, coroners, the Health and Safety Executive, the NMC and the General Medical Council (GMC), to answer patient complaints, and to manage financial liability that may result from an incident. They told us there was a “danger of preventing them from meeting other bits of law that they are required to meet”.114 It became clear, though, that NHS Providers’ concern was about HSSIB conducting “local investigations in place of trusts”,115 as the present HSIB has been required to do by the Secretary of State in relation to 1,000 maternity investigations.116 Whether or not these investigations cut across the duties of NHS trusts (Keith Conradi told us the HSIB investigators took a “very collaborative” approach),117 we have other concerns about the present HSIB having been asked to conduct these additional investigations. We set out our concerns in Chapter 5.118
85.In any event, we expect the duties of co-operation on practical matters between HSSIB and others will ensure that any tension with existing statutory duties will be avoided. We consider the draft Bill’s duty of co-operation in Chapter 6.
Material protected
Extent of the ‘safe space’ (prohibition on disclosure)
86.The prohibition will apply to “any information, document, equipment or other item”, or any information about such things.119 Dr Carl Macrae understood the prohibition to cover “things like statements that are made to the investigators”.120 Keith Conradi considered “the protected piece [to be] the piece of paper that [sensitive information] is written on”;121 and that the witness statements HSSIB will take must remain confidential.122 The Clinical Human Factors Group told us that, in other industries, the protection of information applies to statements gathered by investigators, and that “all existing notes, records, documentation and data remain available to the law enforcement agencies and the regulators/organisation who may choose to investigate in parallel to the independent body.”123
87.On the face of the draft Bill, it applies to “any information [or] document […] held by [HSSIB or the accredited trust] in connection with [an] investigation”.124 The Campaign for Freedom of Information thought the description capable of including, “[p]olicy or procedural documents, information about staffing levels, recruitment problems, financial difficulties, lessons learnt from past incidents [and] information supplied by equipment or product manufacturers”.125 AvMA pointed out the prohibition “applies literally to any information held in connection with the investigation which is not already in the public domain”,126 and indeed to information about that information.127
88.As the Bill is drafted, it is clear that the prohibition on disclosure (by HSSIB or an accredited trust) goes much further than just witness statements. Nevertheless, and in the light of our conclusion in paragraph 63, we conclude that this blanket ban on HSSIB disclosing the evidence that it gathers or generates—with specific exceptions—is the solution most likely to achieve the aim of getting to the truth, in the interests of patient safety.
Information not leading to an investigation
89.The prohibition on disclosure in clause 28 applies only where HSSIB “is carrying out, or has carried out, an investigation”, and only to information, etc, held by HSSIB “in connection with” the investigation.128 As drafted, the ‘safe space’ will not cover information given to HSSIB unless and until a connected investigation is launched. But HSSIB is expected to conduct, initially, only around 30 investigations a year, while it will receive—and want to receive—information about many more. The present HSIB says “every case is logged into our database and becomes an important part of helping us identify patterns of safety issues over time.”129
90.There is a question over whether any information, however it is received by HSSIB, in connection with a patient safety incident, or about patient safety, should be considered to be held in the ‘safe space’. The Minister thought “whistleblowers” would be able to raise concerns and be protected by ‘safe space’.130 If this is the intention, it is not reflected in the present draft of the Bill. The Minister and her officials agreed the Bill as drafted did not cover information where no investigation resulted.131 Chris Hopson of NHS Providers132 and Harry Cayton of PSA133 both supported the extension of the ‘safe space’ to cover this situation. Keith Conradi told us that HSIB has a system allowing anonymous referrals, but accepted that it was possible the referral might contain enough information for a case to be identifiable, though HSIB would want to protect that.134
91.We recommend that the ‘safe space’ protection be extended, so that the prohibition on disclosure in clause 28 covers any information and material disclosed to HSSIB (other than by the Secretary of State or a healthcare provider) which HSSIB reasonably considers to have been provided for the purpose of promoting patient safety, or of inviting HSSIB to investigate a matter relevant to patient safety, whether or not it leads to an investigation.
How safe is the ‘safe space’? (Exceptions to prohibition on disclosure)
92.According to the draft Bill, HSSIB will be able to disclose information from the ‘safe space’ in the following circumstances:
|
If information might be evidence of… |
HSSIB may disclose to… |
Clause |
|
a criminal offence |
Police |
29(2)–(3) |
|
a serious ongoing risk to patient safety |
NHS trusts, various other NHS bodies, or the Secretary of State |
29(4)–(5) |
|
serious misconduct |
Regulator |
29(6)-(7) |
|
any of the above |
NHS trust, person providing NHS services, NHS Commissioning Board, or clinical commissioning group to safeguard any patient |
29(8)–(9) |
|
or to a party in proceedings, where the High Court decides the interests of justice outweigh any adverse impact on future investigations or the Secretary of State’s ability to improve NHS safety |
30 |
93.The Department told us these exceptions reflected “the balance struck between ensuring HSSIB investigations are effective by protecting information appropriately, and ensuring that very serious or ongoing risks to patients or public can be disclosed and acted upon.”135
94.We considered two distinct questions:
a)the circumstances in which HSSIB should be entitled (or required) to disclose anything from the ‘safe space’; and
b)whether such disclosure should extend to the detailed evidence gathered by HSSIB or some more limited class of information.
When HSSIB should be able to disclose
95.In relation to disclosure to the police, Dr Chaand Nagpaul, Chair of Council at the BMA, told us he understood “the criminal bit”.136 The Patients Association also thought it “essential”.137 But disclosure to the police of a criminal offence is not contemplated by HSIB’s current directions; the Chief Investigator is to inform regulators or other investigatory bodies should HSIB become aware “of evidence of a serious, continuing risk to patient safety”.138
96.Regulators broadly welcomed the exception allowing disclosure to them, with some qualifications. Paul Buckley, Director of Strategy and Policy at the GMC, put it this way:
We think that the current threshold in the draft Bill is both too narrow and too low. We think that a better test would be in terms of there being a serious current risk to patients—that is, not just misconduct, but a serious risk.139
The NMC supported this.140 Others shared the view that ongoing risk was the key.141
97.The GMC would have preferred to see a duty on HSSIB to disclose in these cases, rather than a discretionary power,142 as would the CQC143 and AvMA.144 Indeed, Dr Nagpaul highlighted the uncertainty about who at HSSIB will decide whether to refer a person to the regulator.145
98.The CQC felt they needed to know that there were incidents in a particular provider that HSSIB was investigating (without wanting any detail about individuals) before they carried out their inspection, so as to direct them to the right things to look at.146 Harry Cayton called for “a set of rules that are much clearer about what is to be shared, how it is to be shared and what the threshold is that HSSIB is going to apply.”147
99.The Medical Defence Union thought the balance was about right, telling us the exceptions, “are reasonable and proportionate in balancing the harms of diluting the individual protection afforded in a safe space against the harms of failing to act on the basis of either the public interest or patient safety.”148
100.Dr Simon Fleming, a Trauma and Orthopaedic registrar, said he:
would have real concerns if HSSIB were to feed in to regulatory bodies, because people will not report. People will not report someone speeding if they know that they themselves will have to then speak to the DVLA. It is human nature.149
101.The Royal College of Physicians and Surgeons of Glasgow thought there was not enough protection.150 Solicitors Mills & Reeve LLP felt the “risk of criminal liability and regulatory referral will still result in individuals being wary of speaking freely.”151
102.The question is under what circumstances HSSIB should be allowed or obliged to disclose information and evidence protected by the ‘safe space’. We draw a consensus from our evidence. HSSIB should only be expected to disclose such information as is necessary to address a serious and continuing risk to the safety of a patient, or to the public. This is consistent both with the Government’s stated aim for the exceptions and with the principle that HSSIB should be about learning not blaming.
103.The evidence sent to us by Professor Gerada described the extent of poor mental health amongst doctors.152 We recognise that problems associated with mental wellbeing can affect all professional groups in healthcare, all of whom play a critical role in ensuring patient safety. We believe that the protections afforded by the ‘safe space’ will be important to health professionals who are under stress from patient safety investigations or complaints, or who may be managing mental health problems. They will be able to speak more freely in the ‘safe space’ about the nature of their work, its impact on them, and the consequences for patient safety.
What should be disclosed
104.Dr Nagpaul was concerned at the lack of clarity about what will be disclosed: the fact of concern about a particular professional, or the content of the evidence they had provided.153 The NMC thought it ought to be the evidence, otherwise:
a)patients and family members will have to give their account more than once, and
b)there might be conflicting accounts provided, making evidence unreliable.154
105.They were also concerned at having to “expend further resource on conducting [their] own parallel investigations”.155 On the other hand, the Medical and Dental Defence Union of Scotland pointed out that by disclosing evidence:
an individual health practitioner may have lost some of the legal rights and protection they would otherwise enjoy. That is to say, by disclosing information, potentially without the benefit of formal legal advice and support, to a ‘safe space’, that is subsequently shared with the police the health practitioner has in effect given an indirect interview to the police without being cautioned about their legal rights. Similarly, if information is released to the GMC (or other health regulator) the health practitioner has essentially lost the right not to comment that would otherwise be afforded them under the regulator’s rules.156
106.Keith Conradi told us that he thought there should be no exceptions from the prohibition, save for HSSIB being able to “inform the authorities”. He did not want a discretion to hand over information. He said, “I think we could provide some detail but not the actual paperwork that goes with it”, but agreed with the description: “enough information to let the employer, the police or the regulator set off their inquiry, but no more than is necessary.”157
107.We conclude from the evidence that the risk of patients having to give their account twice should be minimised by practical co-operation between the regulators and HSSIB; perhaps an agreed format or set of questions for obtaining a patient’s account, with a copy retained by the patient. We discuss how HSSIB should operate in order to address this later in this Report.
108.We have considered the concern that there is a risk of conflicting accounts rendering evidence unreliable. But we are assured it is unfounded. Any account provided to HSSIB would be protected by the ‘safe space’. Healthcare professionals will remain subject to their professional duties, not least the duty of candour. The ‘safe space’ will have no impact on these duties.
109.We see no reason for HSSIB to disclose evidence it has received, unless it believes there is a serious and continuing risk to the safety of a patient, or to the public. The Chief Investigator of the present HSIB does not think it would be appropriate otherwise. The regulators rightly want greater certainty about what will be disclosed and this should be made clear in the Bill.
110.We recommend that the Government amend clause 29 to permit HSSIB to disclose to police, regulators, and/or trusts:
a)solely on the grounds that there is a serious and continuing risk to the safety of a patient, or to the public; and,
b)no more than the information necessary to enable the recipient of the information to set in train its own enquiries.
111.In relation to the power of the High Court, the NMC said they were “unclear how the considerations set out at section 30(4)(a) and (b) could ever be evidenced other than by a statement to the effect that they apply in a particular case”.158 We understand the concern, but do not share it: the Court has faced and resolved a similar exercise before.159
112.We are satisfied with the provision in clause 30 setting out the power of the High Court to order HSSIB to disclose information, and the test it is to apply. The High Court will only be able to do so if it determines that the interests of justice served by disclosure outweigh any adverse impact on the ability of the Secretary of State to improve the safety of NHS services, or on people’s willingness to participate in future HSSIB investigations. This should only be in the most exceptional circumstances.
Exceptions outside the draft Bill
The Parliamentary and Health Service Ombudsman (PHSO)
113.The PHSO, which fulfils the role of the Parliamentary Commissioner for Administration (PCA) and the Health Service Commissioner for England (HSCE), says it has power to access the HSSIB’s evidence:
Our legislation affords us the same powers as [the] High Court to call for information. We would therefore be able to access information held by the HSSIB and, by extension, NHS Bodies accredited by them. We, therefore, welcome that the Bill does not affect our ability to investigate and remedy injustice in respect of complaints about safety incidents.160
114.Scott Morrish felt this was wrong and shared his concern that “if you leak information via one route or another, be it to the PHSO or to regulators or anybody else, it is not a safe space. As soon as word gets out, it is redundant.”161
115.In its role as PCA, the PHSO will be entitled (subject to various requirements) to investigate maladministration by HSSIB.162 But it may well be wrong about its entitlement to disclosure from the ‘safe space’, at least as regards information held by HSSIB, which is not to be regarded as “the servant or agent of the Crown”.163
116.PHSO is part of the redress and grievance system, which HSSIB will not be, and it would be unhelpful if it could circumvent the prohibitions on disclosure or was perceived as a means of doing so.
117.To avoid any perceived dilution of the ‘safe space’, and to put the question beyond doubt, we recommend that the Bill expressly prohibit both the Parliamentary Commissioner for Administration and the Health Service Commissioner for England from having access to the information and material in clause 28 of the draft Bill, regardless of their entitlement under any other legislation. These bodies are well used to conducting their own investigations without access to HSSIB material. In this respect, the introduction of HSSIB has no impact on them whatsoever, except that they will be able to draw upon the reports and other material published by HSSIB.
The coroner
118.A recent issue before the courts was whether a coroner could call for investigation material from the AAIB. It was held that she could not, but this decision was based on an interpretation of coroners’ powers164 at least in part influenced by EU and international law.165 There are no such influences for the interpretation of this Bill.
119.We recommend that the draft Bill be amended to put beyond any possible doubt that the ‘safe space’ cannot be compromised save in the most exceptional circumstances, and therefore that the prohibition on disclosure applies equally to disclosure to coroners.
120.In the light of the two preceding recommendations and for the avoidance of any doubt, we recommend that the Government clarify, both in public statements and in the legislation, that the prohibition on disclosure is of application in all circumstances, except as provided for in the Bill itself.
Use of information for patient safety reasons
121.Keith Conradi referred to the desirability of being able to share some information without waiting until publication of a formal report, something he told us he could do at the AAIB:
One of the mantras that we have is that there should be no surprises to the addressee of a safety recommendation. Throughout the investigation, we are already discussing what we think needs to be done and what the problems are. By the time we make it—this is certainly so for the ones to date—we have had an understanding from the addressee of what it is we are after.166
and
To go back to aviation, when we were uncovering something with one of the big manufacturers, they were really concerned because commercially it could have been very damaging to them. We make a big point that as we come across factual information, we share it immediately—we are doing this in maternity. We will not hang on to information until the very end, when the report comes out.167
122.There is currently no statutory prohibition on disclosure, and the maternity investigations are taking place without any ‘safe space’ protection in any event. Once enacted, there will be no opportunity for such informal sharing of information, however much it might benefit patient safety and however unlikely it might be that release of this factual information will deter professionals from being frank with HSSIB.
123.Under EU law, air accident investigators are under a duty to communicate any information relevant to accident prevention to those responsible for aircraft manufacture or maintenance, aircraft operation, or training.168 They are also bound to release to aviation authorities “relevant factual information obtained during the safety investigation”, except for sensitive information such as witness statements.169
124.HSSIB needs the freedom (but should not be under any obligation) to release factual information during an investigation which could be of benefit to patient safety. We note that this reflects the way the HSIB currently operates. We therefore recommend the Bill be amended to allow disclosure, where in the view of HSSIB there may be a benefit to patient safety, to regulators, NHS bodies, suppliers, manufacturers, or the Secretary of State, of the information HSSIB deems of potential benefit, but not including—
a)statements taken from any person in the course of an investigation, or submitted to HSSIB for the purpose of inviting it to investigate;
b)any information likely to reveal the identity of—
i)an individual who has given evidence, or
ii)any individual involved in an incident; or
c)drafts of interim or final reports.
125.The Government should consider whether some of the other categories of material ought to be added to the above list of exclusions, and it should be guided by EU air accident investigation provisions.
Use as evidence in court
126.By clause 33, HSSIB’s reports on its investigations will not be available to use in court (unless the High Court were to give permission). This reflects the principle in clause 2(3) that HSSIB investigations are not to assess blame or liability.
127.It is a prohibition which attracted criticism from patient groups, particularly in the context of ‘safe space’ investigations by trusts. Peter Walsh told us: “[i]t would […] be creating a bureaucratic—and costly—nightmare if people know that they will not be able to use the information gleaned from investigations”170 and patients will be “prevented, at both ends, from being a part of the investigation”:171
Even when the investigation draws its conclusions, findings of fact and recommendations, you are not allowed to do anything with it. You can see what has happened, but if you had, for example, a clinical negligence claim, you would not be able to use that information.172
128.Nevertheless, Matthew McGrath of DAC Beachcroft LLP thought that once the information had been published in a report, “it would be very difficult in some respects for it not to be used in some way in civil proceedings”.173 Keith Conradi did not think there was a problem with reports being used in evidence, but it was “important that the caveats that go with the report—the fact that the evidence is not collected in accordance with police standards and the rest of it—are understood”.174
129.The Royal College of Nursing, meanwhile, welcomed clause 33 and said “[i]nformation gathered by the HSSIB should not be admissible to patients and families, as this may undermine the safe space principle.” They called for the clause to be strengthened to allow application only in “exceptional circumstances”.175
130.We understand the concern of some patient groups that they will not be able to use the information published by HSSIB to obtain justice or compensation. However, this does not prevent anyone from using knowledge gained from HSSIB published material to inform the framing of a case for legal redress. As previously stated, we are committed to the principle that this Bill should do nothing to restrict patients’ ability to seek redress. We are satisfied that it does not do so.
Evidence given by HSSIB investigators in coroners’ proceedings
131.Professor Brian Toft pointed out to us that a coroner can call HSSIB investigators to give evidence.176 Keith Conradi said HSIB do not think the use of their reports in inquests is a problem, characterising it as “reasonable and helpful”. He did, however, consider it difficult if reports were used in an “adversarial system” or if HSSIB “got pulled into an adversarial court and then had to make some sort of determination”.177 As Chief Inspector at the AAIB he gave evidence to the Court of Appeal to the effect that, if investigators had to mention to interviewees that any report would be admissible in civil proceedings, it “would likely restrict the free flow of information”.178 By extension, it seems unlikely that HSSIB would be comfortable if reports of evidence given by its investigators to coroners were used in a more adversarial setting. This would also run counter to the prohibition on use of reports in clause 33.
132.There is precedent for evidence given to coroners by HSSIB investigators to be used in other proceedings. The Court of Appeal has observed that in relation to the AAIB the practice is common, and “It is difficult to believe that professional investigators will be inhibited, or the work of the AAIB impaired, by the admissibility in evidence of AAIB reports that have already been made public and are likely to have featured in any coronial investigation.”179 The outcome of that case was to allow the AAIB report to be admissible without balancing the interests of justice against prejudice caused to investigations.180 The same court emphasised the importance of reports—and where appropriate, evidence from investigators—being available to coroners to avoid duplication of investigation.
133.As coroners’ investigations are not conducted with a view to establishing criminal or civil liability,181 it seems unlikely that this will have a ‘chilling effect’ on co-operation with HSSIB. There is no difficulty with coroners using reports from HSSIB and, where appropriate, hearing from its investigators to avoid duplication of investigations.
134.We recommend that any evidence given to the coroner by HSSIB, including that given by investigators in oral evidence, be subject to the same test for admissibility in other proceedings as are reports of HSSIB, so that evidence given to the coroner does not become a ‘back door’ means of using in court information that was shared in the ‘safe space’.
Freedom of information and data protection
135.The News Media Association suggested that the effect of the draft Bill will be to prohibit patients accessing information about themselves, contrary to the EU General Data Protection Regulation (GDPR)182 and the Data Protection Act 2018.183
136.DAC Beachcroft LLP’s view was, in summary, that they were “not convinced that a bar on patients (as data subjects) accessing personal data held by the HSSIB would be disproportionate and contrary to EU law.”184
137.The Department told us it considered HSSIB’s proposed functions:
would fall within the exemption in paragraph 7 of Schedule 2 to the Data Protection Act 2018. In particular HSIB’s functions include (a) protecting the public against dishonesty, malpractice or other seriously improper conduct or unfitness or incompetence and (b) protecting persons other than those at work against risk to health or safety arising out of or in connection with the action of persons at work.
They also said the relevant GDPR provisions will not apply so as to require data to be disclosed in response to subject access requests.185
138.We raised with the Government the question of the draft Bill’s compatibility with data protection legislation (including EU law). There should be no question that the ‘safe space’ could be subject to any data access or freedom of information requests. We are satisfied with the Government’s assurance that ‘safe space’ information would be exempt from access requests under data protection legislation and invite the Government to give us the same assurance in relation to freedom of information requests.
61 Except when discussing an effect of ‘safe space’ which is particularly relevant to investigations carried out by an accredited trust. See paragraph 81.
62 Department of Health, Factsheet 3: The Draft Health Service Safety Investigations Bill ‘Safe space’: what is it, why we need it and how it will work (September 2017), para 1
64 Department of Health, Report of the Expert Advisory Group: Healthcare Safety Investigation Branch (May 2016), p 27
65 Department of Health, Report of the Expert Advisory Group: Healthcare Safety Investigation Branch (May 2016), p 29
66 Department of Health, Report of the Expert Advisory Group: Healthcare Safety Investigation Branch (May 2016), pp 28–29
84 Action against Medical Accidents (AvMA) (SIB0021), p 1. See also Qq194–195; and the Professional Standards Authority for Health and Social Care (SIB0031), para 2.6.
87 Or gave evidence that this would be the effect of the Bill. See The Professional Standards Authority for Health and Social Care (SIB0031), paras 3.3–3.4 and The Campaign for Freedom of Information (SIB0039), para 8; and Medical Defence Union (SIB0044), para 2.
94 Draft Bill, clause 28(2)
96 The Patients Association (SIB0043), para 15. This concern appeared to be shared by Action against Medical Accidents (AvMA) (SIB0021), p 6.
100 See para 168.
101 Explained by the GMC and NMC in Openness and honesty when things go wrong: the professional duty of candour (June 2015), and embodied in the regulatory bodies’ joint statement on the professional duty of candour. Robert Francis QC, in his Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry, recommended that practitioners be subject to a statutory duty of candour (para 1.181).
102 “Registered persons” under the Health and Social Care Act 2008.
103 The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014 No 2936), reg 20, as amended by the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2015 (SI 2015 No 64), reg 10.
104 Q140. See also The Professional Standards Authority for Health and Social Care (SIB0031), paras 3.4 and 3.35.
106 Department of Health, Fact sheet 3: ‘Safe space’—what is it, why we need it and how it will work (September 2017)
110 Clause 28(2)
112 The Professional Standards Authority for Health and Social Care (SIB0031), paras 2.7 and 3.39; The Campaign for Freedom of Information (SIB0039), para 12; Care Quality Commission (SIB0040) para 6.2.2; The Patients Association (SIB0043), para 19
119 Clause 28(2) and 28(6)(c)
124 Clause 28(2)
128 Clause 28(1) and (2)
129 Healthcare Safety Investigation Branch, ‘What we investigate & why’, accessed 5 July 2018
138 The National Health Service Trust Development Authority (Healthcare Safety Investigation Branch) Directions 2016, para 6(4)(c)
147 Q134; see also The Professional Standards Authority for Health and Social Care (SIB0031), para 2.18.
159 See Chief Constable of Sussex Police v Secretary of State for Transport [2016] EWHC 2280 (QB).
162 By virtue of Schedule 2, para 3 of the draft Bill, it will not be entitled to investigate a failure of service by the HSSIB as the Health Service Commissioner for England.
163 Draft Bill, Schedule 1, para 1(1). Thus the prohibition on disclosure will not be disapplied by s 12(3) of the Health Service Commissioners Act 1993, or s 8(3) of the Parliamentary Commissioner Act 1967, which disapply any restriction on the disclosure of information obtained by or supplied to persons in Her Majesty’s service.
164 Under Schedule 5 to the Coroners and Justice Act 2009.
165 R (Secretary of State for Transport) v HM Coroner for Norfolk [2016] EWHC 2279 (Admin)
168 Regulation (EU) No 996/2010, art 15(2)
169 Regulation (EU) No 996/2010, art 15(3)
178 Hoyle v Rogers [2014] EWCA Civ 257, at [76]
179 Hoyle v Rogers [2014] EWCA Civ 257, at [94]
180 Hoyle v Rogers [2014] EWCA Civ 257, at [79] and [98]
181 Coroners and Justice Act 2009, section 10(2)
185 See Appendix 3.
Published: 2 August 2018