Health and Care Bill 2021: Statutory patient safety investigations at last?

By way of headlines, the proposed HSSIB would:

• Investigate incidents occurring during the provision of health care services - whether in the NHS or independent sector (a significant extension since the last version of the proposed legislation) - which have implications for the safety of patients, in order to identify and address those risks via systems improvements
• Have wide powers of entry/inspection and seizure and make it a criminal offence to fail without reasonable excuse to answer questions/provide information to the HSSIB as requested
• Be prohibited from sharing the information sitting behind its investigation reports except in very limited circumstances

In this briefing, we look at what the Health and Care Bill says about the HSSIB and what to expect next.

What is proposed for statutory patient safety investigations?

What the Health and Care Bill (Part 4) is proposing is the introduction of legislation setting up a statutory organisation to be called the Health Services Safety Investigations Body, or ‘HSSIB’ for short (not to be confused with the existing non-statutory Healthcare Safety Investigation Branch or HSIB, which the HSSIB will replace).

The HSSIB’s function will be to investigate incidents occurring during the provision of health care services in England, which have (or may have) implications for the safety of patients, with the purpose of those investigations being to identify risks to patient safety and to address those risks by facilitating the improvement of systems and practices in the provision of NHS or other health care services. 

This marks an important extension of HSSIB’s reach to independent sector healthcare provision, with HSSIB’s remit having been limited in previous incarnations of this proposed legislation to incidents occurring during the provision of NHS services or at premises where NHS services are provided.  Linked with this, the Bill specifies that, where an investigation relates to an incident in non-NHS services, the HSSIB should consider whether systems/practices in NHS services could also be improved in relation to the identified risks.

There is a strong emphasis on this being a ‘no blame’ system, with the proposed legislation stipulating that the purpose of HSSIB investigations will not include assessing/determining blame or civil/criminal liability or whether any individual should be subject to action by their regulatory body.  Indeed individuals are specifically protected from providing information where to do so could result in self-incrimination.

HSSIB will have to publish the criteria it will use when deciding which incidents to investigate, as well as publishing details of the processes it will follow when carrying out its investigations, including how it will ensure that, as far as reasonable/practicable, patients and their families are involved in investigations.

HSSIB powers (plus criminal penalties for non-compliance)

The HSSIB will certainly have ‘teeth’, with the Bill setting out a range of powers the HSSIB will be able to use to essentially require people (if need be) to comply with its investigations.

Specifically, if an HSSIB investigator considers it ‘necessary for the purposes of an investigation’, they will have a power to enter and inspect premises (except private dwellings) and to inspect and seize any documents, equipment or other item from the premises.

The HSSIB will also be able to effectively compel people to be interviewed, by giving notice in writing to any person to attend at a specified time and place to provide information by answering questions.  It will also be able to require people to provide specified information, documents, equipment or other items within a set timeframe.

Importantly, failing without reasonable excuse to comply with an HSSIB notice requiring attendance to answer questions or produce documents/equipment will be a criminal offence, with the person or organisation committing the offence being liable on conviction to a fine.  The potential grounds for legitimately refusing to provide the HSSIB with information are narrow and include where doing so would risk the safety of any patient or would incriminate an individual being asked to provide information.  The Bill also expressly provides that, in complying with a request for disclosure, you must adhere to data protection legislation and do nothing to contravene that.

HSSIB investigation reports (and what they can be used for)

When the HSSIB completes an investigation, it will have to publish a final report setting out its findings of fact, analysis of those findings and its conclusions.  HSSIB reports will also have to set out recommended actions, to be carried out by any person the HSSIB considers appropriate.

The report cannot include any assessment/determination of blame, civil or criminal liability or whether action needs to be taken in respect of an individual by a regulatory body.  As stated in the Bill: “The final report must focus on ascertaining risks to the safety of patients and any recommendations as to action to be taken by any person must focus on addressing those risks (rather than on the activities of individuals involved in the incident).”

Final reports will not be able to name any individuals who have provided information for the investigation or who were involved in the incident being investigated unless they have given their agreement to being named.

In addition, before publishing a final or interim report, the HSSIB will have to send a draft version to any person who the HSSIB reasonably believes could be adversely affected by the report, giving them an opportunity to comment on the draft within a set timeframe.  If a person’s comments on the draft are not taken into account in the final or interim report, the HSSIB will have to explain to the person why this is.

In terms of recommendations, the HSSIB must make the report available to those with recommended actions assigned to them, along with a deadline for providing a written response to the relevant action.  That person will have to respond to the HSSIB in writing before the deadline, setting out the actions they propose to take in response to the recommendations and the HSSIB may publish any response. 

What will HSSIB reports be able to be used for?  The primary purpose of HSSIB reports will be to address patient safety risks across health care systems. They are specifically not to be used for allocating blame or liability.  In line with this, the Bill makes clear that HSSIB reports will not be admissible in proceedings to determine any civil or criminal liability or regulatory body proceedings or in employment tribunals.   The only way around this would be to apply to the High Court for an order that an HSSIB report is admissible in such proceedings.  However, the High Court will only be able to grant such an order if satisfied that the interests of justice served by admitting the report outweigh any adverse impact on current or future investigations by deterring people from providing information for the purposes of investigations, and any adverse impact on securing the improvement of the safety of healthcare services.  How easy or otherwise it will be to get over that hurdle remains to be seen and will no doubt depend very much on the circumstances of the particular case.

Prohibition on HSSIB sharing information sitting behind reports

A key element of the thinking behind the HSSIB was to create what is often referred to as a ‘safe space’ for healthcare professionals when sharing information about how and why incidents affecting patient safety happen, with the idea being that people are more likely to be fully open and frank about what has happened and any systems issues behind that, if they know there can be no repercussions for them personally or professionally in doing so. 

Although the phrase ‘safe space’ does not appear anywhere in the Bill, this remains a key principle behind the provisions in the Bill which will prevent the HSSIB from disclosing what is referred to as ‘protected material’- i.e. any information held by the HSSIB in relation to an incident it is investigating, or has investigated, which has not already lawfully been made public.  This means that any information that does not make its way into the HSSIB’s reports, but was obtained by HSSIB for the purposes of the investigation, is protected from disclosure.

Such is the strength of that protection, that the Bill makes it a criminal offence for anyone working for the HSSIB to breach the prohibition on disclosure by knowingly or recklessly disclosing protected material to another person.  Not only that, but any person who receives ‘protected material’ from the HSSIB also commits an offence if they knowingly or recklessly pass it to someone else without reasonable excuse.

As one might expect, there are a number of exceptions to this prohibition on disclosure, and these are set out in a separate schedule to the Bill.  These exceptions will enable the HSSIB to disclose ‘protected material’ if necessary for the purposes of its investigatory function or for the investigation/prosecution of the various HSSIB related criminal offences in the Bill.  It can also disclose such material if the chief investigator reasonably believes the disclosure is necessary to address a ‘serious and continuing risk’ to the safety of any patient or the public.  The Bill also requires the HSSIB to produce guidance on when it might be appropriate for protected material to be disclosed under these headings.

The other main exception to the prohibition on disclosure is that a person can apply to the High Court for an order that any protected material be disclosed by the HSSIB for the purposes set out in the court application.  The High Court can however only grant such an order if satisfied that the interests of justice outweigh any adverse impact of the disclosure on current or future investigations, as per the test to be applied by the High Court when considering whether HSSIB reports are admissible in proceedings, referred to above.

Under the Bill, bodies with existing statutory powers to require disclosure of information (e.g. professional regulators and the CQC) cannot exercise those powers to obtain HSSIB ‘protected material’ and would instead have to go down the High Court application route.  An important exception to this relates to coroners inquests, with the Bill stipulating that the HSSIB will be able to disclose protected material to a senior coroner.  However, the coroner will not then be able to pass that protected material on to anybody else, unless they obtain a High Court order authorising them to do so.  Coroners may therefore be left in a difficult situation where the coroner is in possession of material which is relevant to the inquest, but cannot be disclosed to the parties involved.

HSSIB’s obligation to help NHS bodies with their investigations (and option to help independent sector too)

Separately from its investigation function, the Bill also requires the HSSIB to comply with any request by a relevant NHS body to provide it with assistance in connection with carrying out investigations into incidents occurring during the provision of NHS services or at premises where NHS services are provided, with such assistance to include disseminating information about best practice, developing standards to be adopted and giving advice, guidance or training.  HSSIB will have to provide the assistance requested, at no charge, unless it determines it is impracticable to do so.

In addition, the HSSIB may - but will not have to - give assistance to a person other than an NHS body (e.g. independent healthcare providers) in relation to any matter connected with carrying out investigations, although the HSSIB will be able to charge on a commercial basis for doing so.

What next?

The Health and Care Bill which will bring the new HSSIB into existence has now started on its journey through Parliament, during which it will undergo various stages of scrutiny and amendment.

In terms of timescale, the government is aiming for April 2022 for the main provisions of the Bill to come into effect. Whilst the goalposts could potentially move on that, the legislation required to bring the HSSIB into being has been a long time coming, so the government is likely to be keen to finally get it up and running.

Organisations that have not done so already should therefore start considering now how they plan to ensure that their Board and staff are fully aware of the HSSIB’s functions and powers, which will be particularly important given the potential criminal offences for non-compliance created under the Bill.  

How we can help

Our national team of specialist healthcare lawyers have extensive experience of supporting and advising providers on a wide range of matters relating to patient safety and the impact of the proposed new HSSIB, including:

• Clinical governance scrutiny to assess the effectiveness of incident investigations, organisational learning and Board leadership/culture on learning;
• Duty of Candour requirements;
• Terms of Reference for investigations into serious incidents;
• Reviewing draft serious incident investigation reports/actions plans;
• Representation and support in relation to further investigations which may be linked to incidents/patient deaths, including inquests and CQC/HSE or police investigations.