Summary

A Department of Health consultation is currently underway on possible changes to the law to create a 'safe space' in relation to NHS patient safety investigations.

What is being proposed is a statutory prohibition on disclosure of material generated during health service patient safety investigations except in very limited circumstances.

The aim is to foster a culture of learning from incidents, thereby improving patient safety by encouraging and empowering staff to give comprehensive and candid information without fear of that information being used unfairly against them. The hope is that this will better assure patients and their families that errors and their causes have been fully explored and understood and improvements made where appropriate.

The consultation recognises the tensions between the 'safe space' proposal, the expectations of patients and families, and the existing disclosure powers of healthcare regulatory, professional regulatory and law enforcement bodies, coroners and public inquiries. It is not clear exactly how these tensions might be resolved. It is anticipated that this will not affect existing Duty of Candour requirements. However the full practical impact of the proposals is yet to be worked through.

What is being proposed and why?

The Department of Health is proposing a change to the law in England to introduce a statutory prohibition on the disclosure of material obtained during NHS serious incident/patient safety investigations unless the High Court makes an order permitting disclosure or a specific exemption applies. These exemptions are likely to be limited to cases involving immediate risks to patient safety or commission of a crime - e.g. intentional harm/gross negligence.

The consultation document builds on recommendations in the Public Administration Select Committee's 2015 report relating to the new Healthcare Safety Investigation Branch (HSIB) which, it is envisaged, will carry out around 30 NHS patient safety incident investigations a year. The HSIB Directions (which came into force on 1 April 2016) set out the 'Safe Space Principle' which the HSIB should follow when making decisions about disclosure of material gathered in the course of its investigations, but the consultation proposals go further by suggesting tighter disclosure controls than those contained in the current HSIB Directions.

The rationale behind the 'safe space' proposal centres on developing a greater culture of learning in the NHS and is based on the premise that the sole purpose of patient safety/serious incident investigations should be to learn from errors and not to attribute blame.

The proposals are based on the model used in the airline industry, where those providing information to air accident investigators do so confidentially, with the output of investigations purely being safety recommendations back to the industry.

How would this work?

The 'safe space' provisions would apply to investigations carried out by NHS Trusts/Foundation Trusts and other providers of NHS-funded health services under the Serious Incident Framework as well as to investigations carried out by the HSIB.

The proposed prohibition on disclosure would apply to information generated during the course of an incident investigation – e.g. witness statements, notes written by investigators, transcripts and electronic recordings of interviews. In terms of any potential clash with the Duty of Candour, the consultation document states that the 'safe space' proposal is not intended to impact on the duty to give patients an initial account of the known facts concerning an incident or to share the outcome of further enquiries.

In line with the regulations governing air accident investigations, the prohibition on disclosure will presumably not extend to the contents of the final investigation report (although this point is not specifically addressed in the consultation document).

What is envisaged is that information gathered in the course of an investigation could not be disclosed to anyone outside the investigation except in the following circumstances:

  • High Court Order - The test being proposed here is that the Court may order disclosure in the interests of justice (if there are existing proceedings) or where disclosure is necessary in the circumstances giving rise to the application, with a requirement for the Court to weigh this up against any adverse impact disclosure may have on the relevant body's investigatory processes in the current and future cases, taking into account the importance of eliciting frank and candid contributions to the investigation.
     
  • Exceptions - It is proposed that the 'safe space' regulations will set out specific circumstances in which the bar on disclosure of investigatory material should not apply. These exceptions are likely to be limited to situations involving immediate risks to patient safety - e.g. disclosing concerns to the police or professional regulatory body if there is a serious and continuing risk to patient safety and informing the police where it appears that a criminal offence has been committed.

Impact

Introducing the proposed statutory prohibition on disclosure of investigatory materials would impact on the powers which regulatory bodies (such as the CQC, HSE, GMC and NMC), the police and coroners currently have to require disclosure of information in the course of their own investigations. Under the 'safe space' proposals, these bodies would themselves have to apply to the High Court to seek such disclosure or conduct their own investigation within their legal framework.

It is also envisaged that information obtained during NHS incident investigations would not be discloseable under the Freedom of Information Act 2000 or the Data Protection Act 1998 (presumably by creating new FOIA and DPA exemptions).

There would also be a significant impact in the context of clinical negligence claims, where disclosure of documents sitting behind incident investigation reports is frequently requested by claimants. If the law is changed as envisaged, such disclosure could only take place if ordered by the High Court in accordance with the test set out above.

Potential hurdles

The DoH itself acknowledges in the consultation document that there are a number of key challenges to creating this statutory 'safe space', including:

  • Existing statutory disclosure powers - It is unclear how, in practice, the 'safe space' proposals will fit in with existing statutory powers of healthcare and professional regulators, the police and coroners to require production of evidence as part of their own investigations.
     
  • Existing legal requirement for candour - There is a potential tension between the concept of non-disclosure central to the 'safe space' proposals and the legal duty to 'act in an open and transparent way' as required by the statutory Duty of Candour. It remains to be seen how this tension would be resolved in practice.
     
  • Difficult balance - As the consultation document itself says, it is difficult to see how you can on the one hand reassure staff that information they give to investigators will not be passed on whilst, at the same time, reassuring patients/their families that they have been given the full facts about the care with no perception of 'cover up'. The consultation also makes reference to the principle of a 'Just Culture' (which would make the distinction between human error and more serious failures) but recognises that investigators may need help in applying some of the principles in individual cases.

What next?

The 'safe space' proposals would involve a significant departure from the law as it currently stands in relation to disclosure of information generated as part of NHS incident investigations, including changes to information governance legislation and the existing powers of numerous regulators/law enforcement agencies to require disclosure of such information from NHS Trusts.

The DoH's consultation document recognises that there are numerous challenges here and suggests a phased approach to implementing the 'safe space' provisions, with one option being to test this in maternity services before rolling it out more widely.

We anticipate that the 'safe space' concept will attract considerable debate and - if it is to result in any changes to the law - it seems likely that there will be a long way to go before this happens.

The consultation is due to close on 16 December 2016.