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Health And Care Act 2022

Contents

Part 4: The Health Services Safety Investigations Body

Introductory

Section 109: Establishment of the HSSIB

  1. This section establishes the Health Services Safety Investigations Body ("the HSSIB") as a body corporate. It also gives effect to Schedule 13.

Schedule 13: The Health Services Safety Investigations Body

Part 1 – Constitution
  1. This part of the Schedule provides for the HSSIB’s governance arrangements. It includes details of the membership of the HSSIB and the process for appointments, including the appointment of the Chief Investigator, and sets out the HSSIB’s financial and reporting obligations.
Status
  1. In Paragraph 1 of the Schedule the HSSIB’s status is confirmed as a non-Crown organisation, in line with the status of other Non-Departmental Public Bodies. The HSSIB is not to be regarded as a servant or agent of the Crown and will not enjoy any status, immunity or privilege of the Crown. The HSSIB’s property will not be regarded as property of, or property held on behalf of, the Crown.
Membership
  1. Paragraph 2 of the Schedule provides that the HSSIB is to consist of executive members, including a Chief Investigator, and non-executive members consisting of a chair and at least four other members who will form the HSSIB’s board.
  2. The HSSIB must have more non-executive than executive members.
The Chief Investigator: appointment and status
  1. Paragraph 3 of the Schedule provides that the chief executive is also known as the Chief Investigator. The Chief Investigator is appointed by the non-executive members, with the consent of the Secretary of State. They are to be an employee of the HSSIB.
Other executive members: appointment and status
  1. Paragraph 4 of the Schedule provides that the other executive members are to be appointed by the non-executive members of the HSSIB and no more than five executive members (in addition to the Chief Investigator) can be appointed without the consent of the Secretary of State. This is intended to ensure that the HSSIB’s board remains at an appropriate size and composition and to ensure that the appointment of any additional members is justified. The executive members are to be employees of the HSSIB.
Non-executive members: tenure
  1. Paragraph 5 of the Schedule makes provision for some the terms and conditions of appointment and tenure of office for the HSSIB’s non-executive members. The maximum term of office for non-executive members is six years (the initial appointment can be for three years plus possible reappointment for a further three). The Secretary of State may suspend or remove a non-executive member from office, on the grounds of incapacity, misbehaviour, or failure to carry out duties properly.
Non-executive members: suspension from office
  1. Paragraph 6 of the Schedule applies where a non-executive member is suspended from office under paragraph 5(4). The Secretary of State must provide the individual with notice of the suspension. The initial period of suspension must not exceed six months, and the Secretary of State may review the suspension at any time. In addition, the Secretary of State must review the suspension if requested to by the person in writing. However, there is no requirement to review the suspension before three months have passed following the start of the suspension.
  2. After a review during a period of suspension, the Secretary of State may confirm the suspension, revoke the suspension, or suspend the person for another period of not more than six months. This period would begin once the current period of suspension expires.
  3. The Secretary of State must revoke the suspension if the Secretary of State decides that there are no grounds to remove the person from office under paragraph 5(3) or decides that there are grounds to remove the person from office, but does not remove the person from office under that provision.
  4. Paragraph 7 provides that if the chair is suspended from office under paragraph 5(4), the Secretary of State may appoint a non-executive member as interim chair to exercise the chair’s functions. This appointment is for a term not exceeding the shorter of the remainder of the interim chair’s term as a non-executive member, the period ending with the appointment of a new chair, or the period ending with the revocation or expiry of the existing chair’s suspension.
  5. If a person’s initial term as interim chair ends as a result of the expiry of their term as a non-executive member and they are to be re-appointed as a non-executive member, they may be re-appointed as interim chair for a further term in accordance with paragraph 7(2). The further term must begin at the end of their initial term as interim chair.
Non-executive members: payment
  1. Paragraph 8 of the Schedule provides that the HSSIB must pay to non-executive members such remuneration as the Secretary of State may decide. The HSSIB must pay or make arrangements for the payment of pensions, allowances or gratuities as the Secretary of State may determine for any person who is or has been a non-executive member. If the Secretary of State decides there are exceptional circumstances which means that someone who is no longer a non-executive member should be compensated, the HSSIB must pay compensation to the person of such amount as the Secretary of State may determine.
Staff
  1. Paragraph 9 of the Schedule provides that the HSSIB may employ staff on such pay, terms and conditions as it may determine, following Secretary of State’s approval of its policy on the remuneration, pensions etc. of employees.
Procedure
  1. Paragraph 10 of the Schedule states that the HSSIB has the power to regulate its own procedure and any vacancy amongst the members does not affect the validity of its actions nor does a defect in the appointment of any member.
Committees
  1. Paragraph 11 of the Schedule provides that the HSSIB may appoint committees and sub-committees and pay remuneration and allowances to committee members if they are not employees of the HSSIB.
Exercise of functions
  1. Paragraph 12 of the Schedule provides that the HSSIB must exercise the functions conferred on it by this Part effectively, efficiently and economically, as with other public bodies in the health service. The provision places the HSSIB under the same duty of economy and efficiency as other public bodies in the health service.
  2. The HSSIB can delegate authority to carry out its functions to any non-executive member, any employee or a committee or sub-committee.
Assistance in exercise of functions
  1. Paragraph 13 of the Schedule provides that the HSSIB can obtain assistance from other persons, for example experts, in exercising its functions.
Funding
  1. Paragraph 14 of the Schedule provides that the Secretary of State may fund the HSSIB’s activities to the extent that the Secretary of State considers appropriate.
Supplementary powers
  1. Paragraph 15 of the Schedule provides that the HSSIB can do anything which will facilitate, or discharge any of its functions. This includes powers to enter into agreements, buy or sell property, supply goods and services and develop, own and exploit intellectual property. With consent of the Secretary of State, the HSSIB may temporarily borrow money by way of overdraft.
Use of income from charges
  1. Paragraph 16 of the Schedule provides that any income that the HSSIB generates through imposing charges under sections 127(8) or 128(4) must be re-invested in carrying out those functions.
Losses and liabilities etc
  1. Paragraph 17 of the Schedule provides that the HSSIB is included in the list of authorities covered by section 265 of the Public Health Act 1875. The effect of this is to protect members and officers of the HSSIB from personal liability in certain circumstances.
Accounts
  1. Paragraphs 18 and 19 of the Schedule state that as a Non-Departmental Public Body, the HSSIB is required to keep proper accounts and prepare a set of accounts for each financial year. The Secretary of State may direct the HSSIB as to the form, content, and methods and principles to be applied in the preparation of its accounts. The HSSIB must send its annual accounts to the Secretary of State and the Comptroller and Auditor General who is responsible for examining, certifying and reporting on the accounts and for laying copies of the audited accounts (and his report on them) before Parliament.
Reports and other information
  1. Paragraph 20 of the Schedule provides that the HSSIB must publish an annual report on how it has exercised its functions. The annual report must be sent to the Secretary of State and laid before Parliament. The HSSIB may also be required to provide further reports and information about the exercise of its functions to the Secretary of State, but not the details of specific investigations.
  2. Examples of the information that might be requested are:
    • Information about salaries for auditing;
    • Performance data for parliamentary scrutiny;
    • Costing data for budget setting;
    • Employee data for equalities monitoring.
Seal and signature
  1. Paragraph 21 of the Schedule provides that the HSSIB’s seal must be signed by any member of the HSSIB or any other person authorised for that purpose, for it to be authenticated.
Part 2: Transfer Schemes
  1. Paragraph 22 of the Schedule provides that the Secretary of State may make one or more transfer schemes in connection with the establishment of the HSSIB, to transfer to the HSSIB any property, rights or liabilities of NHS England relating to NHS England’s functions pursuant to any directions made under section 44 of this Act, which are in force at the time the scheme is made.
  2. Paragraph 23 of the Schedule provides that the Treasury may make regulations to vary the way in which a relevant tax has effect in relation to transfers under the scheme. This is a similar provision as can be seen elsewhere in the Act in respect of transfer schemes. The intention is that any transfer of assets, rights, or liabilities be tax neutral for NHS England and the HSSIB. This paragraph provides a power for the Treasury to vary any relevant tax in order to ensure that no taxes arise.

Investigations

Section 110: Investigation of incidents with safety implications

  1. This section gives the HSSIB the function of investigating "qualifying incidents". These are incidents that that occur in England during the provision of health care services and have, or may have, implications for the safety of patients. The purpose of the investigation is to identify the risks to the safety of patients and address those risks by facilitating the improvement of systems and practices in the provision of health care services in England (under section 110(2)).
  2. The HSSIB could investigate a qualifying incident that occurred during the provision of health care services in any setting in England, including in the NHS or in the independent sector. The purpose of its investigations are to identify risks to the safety of patients and to address them by facilitating improvements in the health care system.
  3. Where an investigation relates to an incident that did not occur during the provision of NHS services, the HSSIB must consider whether, in relation to any risks identified, the systems and practices in the provision of NHS services could be improved (under section 110(3). NHS services means health care services provided in England for the purposes of the health service continued under section 1(1) of the National Health Service Act 2006. The HSSIB will determine and publish the criteria it will use to determine which qualifying incident it will investigate (under section 111(1)).
  4. The aim is that the HSSIB will gather evidence which leads to systemic learning from investigating patient safety incidents and share these to prevent a recurrence of a similar incident elsewhere. The HSSIB will make recommendations in its reports and will require the relevant body to respond within a specified period, setting out the action they intend to take in response to that recommendation. Section 110(4) provides that the HSSIB’s investigations are not for the purposes of assessing or determining blame, civil or criminal liability, or action to be taken by a professional regulator in respect of an individual.

Section 111: Deciding which incidents to investigate

  1. This section outlines how the HSSIB determines which qualifying incidents it should investigate as part of its function under section 110. Section 111(2) also gives the Secretary of State the power to direct the HSSIB to carry out an investigation of a particular qualifying incident that has occurred, or group of qualifying incidents that have occurred and are of a particular description, and to specify the date by which the HSSIB must publish its final report. The Secretary of State may also issue a further direction specifying a later date (for example, to grant an extension).
  2. Once the HSSIB has begun an investigation, it must publish a statement reporting that it has begun the investigation. This must include a brief description of the incident(s) under investigation, and set out, in general terms, the issues that the HSSIB expects to consider in the investigation. The HSSIB may give advance notice of such a statement to any person the HSSIB considers may be affected by the investigation. This may include, but is not limited to, patients, families, any individual who has referred the incident to the HSSIB, or an NHS Trust or other healthcare provider.
  3. Where the HSSIB discontinues an investigation, it must publish a statement reporting that it has discontinued the investigation, and its reasons for doing so.
  4. If the HSSIB decides not to investigate a qualifying incident, it may give notice of this to any person the HSSIB considers to have an interest in the determination. This may include, but is not limited to, patients, families, any individual who has referred the incident to the HSSIB, or an NHS Trust or other healthcare provider. In doing so, the HSSIB may include a brief description of the incident and explain its reasons for not investigating.

Section 112: Criteria, principles and processes

  1. This section outlines that the HSSIB must determine and publish the criteria it will use to determine the incidents it will investigate, the principles that will govern investigations, the processes that will be followed in carrying out investigations, and the processes for ensuring that, so far as reasonable and practicable, patients and their families are involved in investigations. It is expected that this will include the process that will be used to determine how interested parties (e.g. patients, families, and staff in both the NHS and independent sector, as well as staff in other health bodies such as NHS England) will be involved in the investigations. The processes must include the procedures and methods to be used in investigations, including the interviewing of persons, and the time periods within which the HSSIB will aim to complete investigations (under section 112(2)). Different types of investigation may have different processes in carrying out investigations and involving patients and families. Anything which is published concerning the processes for patient and family involvement in investigations must be easily accessible by patients and families and capable of being understood by them (under section 112(4)). The intention is that the HSSIB will make all necessary efforts to involve patients and families in investigations, as far as is reasonable andand practicable. However, where individuals cannot be reached, despite efforts made by the HSSIB, or where they refuse to participate, this should not prevent the HSSIB from proceeding with its investigation.
  2. Section 112(7) sets out that in developing these criteria, principles and processes, the HSSIB must consult the Secretary of State and any other persons as they think appropriate.
  3. The HSSIB must review the criteria, principles and processes once in the first three years after publication and at least once every five years after the first review (under section 112(5)), and if revising following review must consult the Secretary of State or other persons the HSSIB considers appropriate. The aim of these provisions is to encourage the HSSIB to change and improve its methods as it becomes more experienced in conducting safety investigations.

Reports

Section 113: Final reports

  1. Section 113(1) outlines that the HSSIB must publish a "final report" on the outcome of its investigations. The report must include a statement of findings of fact and an analysis of the investigation’s findings together with any recommendations as to the action to be taken by any person that the HSSIB considers is appropriate. If the investigation relates to an incident that did not occur during the provision of NHS services, the report must also set out the HSSIB’s conclusions on the matters it considered with regard to section 110(3). This section outlines that in these circumstances the HSSIB must consider whether, in relation to any risks identified, the systems and practices in the provision of NHS services could be improved.
  2. In making recommendations, the HSSIB must focus on addressing risks to the safety of patients, rather than on the activities of individuals involved in the incident. In particular, the final report may not include any assessment or determination of blame, civil or criminal liability, or whether action needs to be taken in respect of an individual by a regulatory body (under section 110(4)).
  3. Set out by section 113(5), protected material may be disclosed in the final report if the HSSIB determines that the benefits to patient safety served by the disclosure outweigh any adverse impact on current or future investigations by deterring people from providing information to the HSSIB, and any adverse impact on securing the improvement of the safety of health care services provided to patients in England.
  4. Names of individuals who provided information to the HSSIB for the purposes of the investigation, or who were involved in the incident under investigation, must not be included in the report, unless they have given their express permission to the HSSIB to do so.
  5. Where an investigation is carried out following a direction from the Secretary of State under section 111, the HSSIB must send a copy of the final report to the Secretary of State.

Section 114: Interim reports

  1. The HSSIB may publish an "interim report" during an investigation. The interim report may contain findings of fact and an analysis of the investigation’s findings together with any recommendations as to the action to be taken by any person that the HSSIB considers is appropriate. If the investigation relates to an incident that did not occur during the provision of NHS services, for example, in an independent hospital, the report may also set out the HSSIB’s conclusions with regard to section 110(3). The aim is to address urgent risks to the safety of patients quickly, or issues that are known early in an investigation, so that swift action can be taken and lessons learned across health care systems.
  2. Interim reports are subject to the same conditions as final reports, as set out in section 113(3) to (7).

Section 115: Draft reports

  1. Before publishing a final or interim report, the HSSIB:
    1. must circulate a draft of the report to any person who the HSSIB reasonably believes could be adversely affected by the report, or where that person has died to the person who the HSSIB believes represents their best interest (if any) (under section 115(1)(a));
    2. may send a draft report to any other person who the HSSIB believes should be provided with a draft (under section 115(1)(b));
    3. must notify every person to whom a draft report has been sent that they have the opportunity to comment before a specified deadline. If a person’s comments are not taken into account, the HSSIB must explain to the person why this is (under section 115(3) and (4)).

Section 116: Response to reports

  1. This section outlines the procedure for when a report from the HSSIB makes recommendations for future action. The HSSIB must make a report available to a person who is in receipt of recommendations, in a manner the HSSIB thinks is appropriate. As outlined in section 115(4), the addressees of the report must, by the HSSIB’s deadline, provide a written response to the HSSIB setting out the action it will take in relation to the recommendations. The HSSIB may publish the response.
  2. Section 226(4) means that the duty to respond would not apply to any body that is, or could be, established by the Welsh Parliament such as health service bodies. The HSSIB may make recommendations to persons in Wales who would be required to respond.

Section 117: Admissibility of reports

  1. Unless the High Court makes an order to the contrary, final and interim reports prepared by the HSSIB following an investigation (including drafts of those reports) are not admissible in certain types of proceedings, including:
    1. proceedings to determine civil or criminal liability;
    2. proceedings before any employment tribunal;
    3. proceedings before a regulatory body (including proceedings for the purposes of investigating an allegation);
    4. proceedings to determine an appeal against a decision made in any of the above types of proceedings.
  2. Set out by section 117(3), the High Court may order that a final or interim report is admissible in the above proceedings in response to an application to the Court by a person who is a party to proceedings or otherwise entitled to appear in them. The HSSIB would be able to make representations to the Court about any application, for example to explain its reasons for not wanting the report to be considered as evidence in the proceedings.
  3. Section 117(5) outlines that the High Court may only make an order that a report of the HSSIB is admissible if it determines that the interests of justice served by admitting the report outweigh:
    1. any adverse impact on current or future investigations by the HSSIB by deterring persons from providing information, and,
    2. any adverse impact on securing the improvement of the safety of health care services provided to patients in England.

Investigatory Powers etc

Section 118: Powers of entry, inspection and seizure

  1. In carrying out its function of investigating incidents, the HSSIB will engage with those under investigation and those managing the organisations where the investigation is taking place. It is expected that in most cases, the staff and organisation will co-operate with the HSSIB investigators, consent to the investigators entry to premises and provide relevant documents. However, where consent is not given, section 118(1)(a) gives the HSSIB powers to enter and inspect premises in England.
  2. These are similar powers to investigatory bodies in other safety-critical industries, such as the Air Accident Investigation Branch (AAIB).
  3. If a HSSIB investigator considers it necessary for the purposes of an investigation they may enter and inspect premises in England; inspect and take copies of documents at the premises, or capable of being viewed using equipment at the premises, for example if the document is stored in the cloud; inspect any equipment or other item; and seize and remove any documents, equipment or items (unless doing so would put a patient’s safety at risk).
  4. Where any document, equipment or other item is seized by an investigator (including where a copy is taken), the HSSIB may retain it for as long as is necessary for the purposes of investigation (under section 118(3)).
  5. The power of entry does not apply to premises which are used wholly or mainly as a "private dwelling". An investigator can therefore only enter a private dwelling with consent. This could apply, for example, where domiciliary care is provided to a patient and would mean that an investigator would need to obtain consent from the resident before entering their home.
  6. If asked, an investigator must show evidence that they are acting on behalf of the HSSIB. This will normally be a letter of authority from the Chief Investigator.
  7. There are specific provisions which apply where the HSSIB wishes to enter premises in which there is a Crown interest. This may be for example, in prisons, other secure institutions and premises occupied by armed forces personnel, where health care is provided.
  8. Section 118(5) provides that the HSSIB must give reasonable notice to the occupier of the premises before exercising its powers of entry, inspection and seizure if there is a Crown interest in the premises. This will allow arrangements to be made to ensure the safety of the HSSIB investigators and to maintain security at the premises being inspected.
  9. If the Secretary of State believes that it is appropriate and in the interests of national security, the powers conferred by 118(1) can be limited through issuing a certificate. In summary these are powers of entry, inspection and seizure. This limitation can include restricting the exercise of the powers in relating to land where there is a Crown interest (as specified in the certificate), or restricting the powers so they are not exercisable in relation to premises which are specified, except in the circumstances outlined in the certificate. The definition of "Crown interest" is set out at section 118(7).

Section 119: Powers to require information etc

  1. This section makes provision for an investigator to obtain information, documents, equipment or other items. An investigator may give a notice requiring someone to attend at a specified time and place to answer questions or to provide information, documents, equipment or other items as specified or of a description specified in the notice by a specified date.
  2. An investigator may only give a notice in certain circumstances, specified in 119(2). A notice must outline the grounds the investigator has for believing they have fulfilled the circumstances in which a notice may be given and attach evidence of the investigator’s authority from the HSSIB to exercise the powers conferred in this section. It must also give a timescale for responding and an explanation of the consequences of failing to comply with the notice i.e. it could be a criminal offence, as set out in section 121. A person who commits this offence is liable on summary conviction to a fine.
  3. Information held in an electronic form may be required in a form in which it is legible, and this should be made clear in the notice.
  4. This section sets out the safeguards that apply where a notice is served. A person is not required by virtue of the notice to provide any information, document, equipment or other item where its provision would risk the safety of any patient, its provision might incriminate the person, or in the case of the information of document, the person would be entitled to refuse to provide it in any legal proceedings in any court on the grounds it is subject to legal professional privilege.
  5. An investigator may withdraw a notice issued under this section.
  6. This section allows the HSSIB to retain any document, equipment or other item provided to an investigator, for as long as is necessary, for the purposes of an investigation unless its retention would risk the safety of any patient.
  7. A person attending to answer questions pursuant to a notice must be reimbursed by the HSSIB for any reasonable costs incurred in attending. The HSSIB may record, by any means, such as in writing or electronically, the answers given by a person for the purposes of an investigation.

Section 120: Voluntary provision of information etc

  1. This section allows a person to disclose information, documents, equipment or other items to the HSSIB if he or she reasonably believes that disclosure is necessary to enable the HSSIB to carry out its functions, set out in section 110. A disclosure authorised by this section does not breach any obligation of confidence owed by the person making the disclosure, or any other restriction on disclosure (section 113(1)).

Section 121: Offences relating to investigations

  1. This section creates new criminal offences for intentionally obstructing an investigator in the performance of functions conferred under section 118 (power of entry, inspection and seizure), or failing to comply with a notice under section 119 without a reasonable excuse. For example, if an individual intentionally obstructed an inspector from entering and inspecting premises in England, this would be an offence. If a notice under section 119 required a person to attend an interview at a given time and place, and they did not do so (without reasonable excuse), this would be an offence.
  2. It is also a criminal offence to knowingly (or suspectingly) provide false or misleading information to the HSSIB, for the purposes of its investigation function, under section 121(2). This could include providing information to an investigator as part of the investigation of a qualifying incident. But if a person discovers falsified or misleading information which they want to disclose to the HSSIB, they can do so, provided that they explain that they think the information is false. They would also need to demonstrate that they reasonably believed the information would help the HSSIB in carrying out its investigation function. If so, this would constitute a defence.
  3. If a person relies on this defence, and there is evidence which raises issues with the defence, the court must presume that the defence is satisfied, until the prosecution proves beyond reasonable doubt that it is not.
  4. Section 121(5) sets out that a person who commits any of the offences will be liable on summary conviction to a fine set by the courts. Persons in the public service of the Crown are not exempt from the offence of intentionally obstructing an investigator in the performance of their functions or being liable upon summary conviction to a fine.

Protection of Material Held by the HSSIB

Section 122: Prohibition on disclosure of HSSIB material

  1. This section prevents the HSSIB, or any individual connected with the HSSIB from disclosing "protected material" to any person. In this context, protected material includes any information, document, equipment or other item which is held by the HSSIB (or a connected individual) for the purposes of the HSSIB’s investigation function, relates to a qualifying incident (regardless of whether it is being investigated) and has not already been lawfully made available to the public.
  2. Section 122(2) sets out that any information, documents, equipment or other item which is held by the HSSIB (or a connected individual) for the purposes of the HSSIB’s investigation function, relates to a qualifying incident (whether or not investigated by the HSSIB), and which has not been lawfully been made available to the public, is to be regarded as "protected material". The aim is to create a "safe space" within which participants can provide information for the purposes of an investigation in confidence and therefore feel able to speak openly and candidly with the HSSIB.
  3. The safe space applies both to protected material obtained before the HSSIB decided whether to investigate as well as to material held in connection with an investigation already underway or completed.
  4. Section 122(3) to (5) defines who the main prohibition on disclosure applies to. This includes past and present members of the HSSIB, including committee and sub-committee members, investigators and administrators or other workers of the HSSIB including apprentices and agency workers.

Schedule 14: Prohibition on disclosure of HSSIB material: exceptions

Disclosures for purposes of investigations
  1. Paragraph 1 of the Schedule provides that the HSSIB, or an individual connected with the HSSIB, may disclose protected material to an individual connected with the HSSIB if either the person making the disclosure, or an authorised person reasonably believes that the disclosure is necessary for the purposes of carrying out the HSSIB’s investigation function.
  2. In this context, "authorised person" means an individual who is connected with the HSSIB and authorised by the HSSIB for this purpose.
  3. Paragraph 2 of the Schedule provides that the HSSIB, or a connected individual, may disclose protected material to a person who is not connected to the HSSIB if the Chief Investigator reasonably believes that the disclosure is necessary to carry out the HSSIB’s investigation function.
Disclosures relating to prosecution or investigation of offences
  1. Paragraph 3 of the Schedule provides that either the HSSIB or a connected individual may disclose protected material to a person if the Chief Investigator reasonably believes that the disclosure is necessary for the prosecution or investigation of an offence under section under section 121 (offences relating to investigations) or under section 124 (offences of unlawful disclosure).
Disclosures relating to safety risks
  1. Paragraph 4 of the Schedule provides that the HSSIB, or a connected individual, may disclose protected material to an individual where the Chief Investigator reasonably believes that disclosure is necessary to address a serious and continuing risk to the safety of any patient or to the public.
  2. However, the HSSIB may disclose no more than is necessary, to enable the person in receipt of the protected material to take steps to address the risk. The protected material may only be disclosed to an individual who the Chief Investigator reasonably believes is in a position to address that risk. For example, where the HSSIB has evidence of negligent behaviour by a medical professional, which may risk the safety of patients and considers that the employer is able to take steps to address the risk it could only disclose information which is sufficient to enable the employer to take those steps e.g. perhaps to enable it to carry out their own investigation/internal process.
Disclosure by order of the High Court
  1. Paragraph 5 of the Schedule provides that a person may apply to the High Court for access to protected material for specified purposes. This may include onward disclosure to a person specified in the application.
  2. The HSSIB may make representations to the High Court if an application for disclosure is made.
  3. The High Court may only make an order to allow the protected material to be disclosed if it determines that the interests of justice served by disclosing the protected material in question outweigh:
    • any adverse impact on current and future investigations by the HSSIB by deterring persons from providing information for investigations, and
    • any adverse impact on securing the improvement of the safety of health care services provided to patients in England.
Exercise of Chief Investigator’s functions
  1. Paragraph 6 of the Schedule gives the Chief Investigator the power to delegate functions under any provision of Schedule 14 to an HSSIB investigator. The delegation of such functions may relate to all cases, a particular case, or certain type of cases.
Guidance
  1. Paragraph 7 provides that the HSSIB must publish guidance setting out the circumstances in which the HSSIB may exercise its power to disclose under paragraphs 2, 3 or 4 of Schedule 14, the types of protected material it might be appropriate to disclose under such a provision, and the processes it should follow when disclosing protected material. Any revised guidance must also be published.

Section 123: Exceptions of prohibition on disclosure

  1. This section specifies that the prohibition on disclosure set out in section 122(1) does not apply to a disclosure authorised or required by schedule 14 (which lists exceptions to the prohibition on disclosure), any other provision of Part 4 of the Act, or regulations made by the Secretary of State, as set out in this section.
  2. This section provides for a regulation-making power for the Secretary of State. This allows for regulations to be made authorising the disclosure of protected materials. However, regulations may not authorise the disclosure of all protected material by reference to the incident to which it relates (subsection (3)).

Section 124: Offences of unlawful disclosure

  1. A person commits an offence if they breach the prohibition on disclosure of protected material held by the HSSIB (section 122(1)) by knowingly or recklessly disclosing protected material to another person, and they know or suspect that disclosure is prohibited..
  2. A person formerly connected with the HSSIB commits an offence if they breach the prohibition on disclosure under section 122(5) by knowingly or recklessly disclosing protected material to another person, and they know or suspect that disclosure is prohibited.
  3. A person who is not connected with the HSSIB, but who receives protected material from the HSSIB in accordance with paragraphs 2-4 of schedule 14, or a draft report, or under any regulations made under section 123(1)(c), commits an offence if they knowingly or recklessly disclose protected material to another person without reasonable excuse, and they know or suspect that the material in question is protected material.
  4. A person who commits an offence under this section is liable on summary conviction to a fine.

Section 125: Restriction of statutory powers requiring disclosure

  1. This section prevents a power in any other legislation being used to require disclosure of, or to seize, any protected material from the HSSIB. Section 125(3) ensures that the section will not impact on any provision that is within the competence of a devolved legislature.

Relationship with other bodies

Section 126: Co-operation

  1. This section recognises that other health bodies may be investigating the same or a related incident to that being investigated by the HSSIB which could raise logistical issues. Both the HSSIB and the listed health bodies must co-operate with each other in respect of practical arrangements for co-ordinating those investigations such as appropriately sequencing investigations. The listed health bodies are:
    1. an NHS foundation trust, an NHS trust or any other person providing NHS services;
    2. NHS England;
    3. an integrated care board;
    4. a Special Health Authority;
    5. the Care Quality Commission;
    6. the Health Research Authority;
    7. the Human Tissue Authority;
    8. the Human Fertilisation and Embryology Authority;
    9. Health Education England;
    10. the Health Service Commissioner for England;
    11. the Parliamentary Commissioner for Administration;
    12. any regulatory body (as defined at section 135);
    13. the Health and Safety Executive;
    14. the Commissioner for Patient Safety.
  2. Section 126(4) and (5) requires the HSSIB to publish guidance clarifying when incidents should be regarded as related and must publish any revisions to the guidance.

Section 127: Assistance of NHS bodies

  1. In addition to its core investigatory functions, the HSSIB may disseminate information about best practice in carrying out investigations, developing standards to be adopted in carrying out investigations and providing advice, guidance or training. Where requested to do so, the HSSIB must give assistance to the following NHS bodies relating to the carrying out of investigations into incidents occurring during the provision of NHS services or occurring at premises at which NHS services are provided: NHS trusts, NHS foundation trusts, and the NHS England and integrated care boards. The Secretary of State, NHS England or the body itself may request the assistance. If the assistance sought is the provision of advice, guidance or training, the HSSIB would not be bound to provide this assistance if it decided it was impracticable for it to do so.
  2. The HSSIB may also give assistance to other persons not listed in subsection (2), including independent providers of healthcare services. The HSSIB may only give assistance to such persons where the assistance is connected to a matter related to the carrying out of investigations and they are requested to do so by the person themselves. The HSSIB may only provide assistance in these circumstances where the assistance does not significantly interfere with the HSSIB’s investigation function. The activities which the HSSIB may carry out in order to give this assistance is not restricted to activities carried out in the United Kingdom.
  3. Except in the case of the listed NHS bodies in England, the HSSIB may charge a fee for sharing its expertise on a commercial basis.

Section 128: Investigations relating to Wales and Northern Ireland

  1. Section 128 allows the HSSIB to enter into an agreement with a person to carry out an investigation in the UK if the investigation falls within subsection (2). That subsection requires, amongst other things, for the investigation to be into one or more incidents that have occurred or are occurring in the UK during the provision of services provided as part of the health service in Wales or health care in Northern Ireland (as defined at subsection (3) or on premises where those services are provided). The investigations will be similar to other HSSIB investigation in that they will not involve the assessment or determination of blame or civil or criminal liability but they will not benefit from protected information or other investigatory powers which apply to the HSSIB’s investigation function. These investigations can be charged for (subsection (4)) but the HSSIB cannot make a profit as the charges must not exceed the costs incurred by it (subsection (5)). This is a secondary function of the HSSIB and so agreements cannot be entered into under this section if they will, to a significant extent, interfere with the exercise of the HSSIB and its investigation function (subsection (6)).
  2. The HSSIB may impose charges for providing services under an agreement to carry out these investigations. These investigations may only be entered into by the HSSIB if it considers that the provision of services under the agreement will not, to any significant extent, interfere with the exercise by the HSSIB of its investigation function.
  3. The HSSIB cannot contract to provide such investigations in respect of Scottish Health care but bodies in Scotland may request expertise from HSSIB under section 127 during the course of its own investigation.

Oversight of functions

Section 129: Failure to exercise functions

  1. This section provides for intervention by the Secretary of State should the HSSIB fail significantly to carry out its functions (which includes failing to carry them out properly). In that event, the section confers on the Secretary of State a power to direct the HSSIB as to how to exercise its functions, setting a time frame if appropriate. In the event that the HSSIB failed to comply with such directions, the Secretary of State may exercise the functions in question or arrange for another party to do so. The Secretary of State, when giving a direction, cannot direct the HSSIB about the outcome of a particular investigation.

Section 130: Review

  1. This section confers a duty on the Secretary of State to review the effectiveness of the HSSIB in exercising its investigation function, to prepare and publish a report of that review, and to lay the report before Parliament. This must be done before the end of the four years following the section of the Act which establishes the investigation function (section 110) coming into force.

Offences: supplementary

Section 131: Offences by bodies corporate

  1. This section deals with corporate liability. If an offence under Part 4 of the Act is proved to have been committed with the consent or connivance of an officer of a body corporate or is attributable to any neglect on the part of an officer, then the individual officer as well as the body corporate, commits the offence and is liable to be proceeded against and punished accordingly. An officer of a body corporate means a director, manager, secretary or other similar officer or anyone purporting to act in any such capacity.

Section 132: Offences by partnerships

  1. This section provides for when an offence has been committed by a partnership, such as a GP partnership, and allows proceedings to be brought in the name of the partnership as well as the individual partners.
  2. If an offence under Part 4 of the Act is proved to have been committed with the consent or connivance of a partner or is attributable to any neglect on the part of a partner, then the individual partner (which includes a person purporting to act as a partner), as well as the partnership commits the offence and is liable to be proceeded against and punished accordingly.
  3. A fine imposed on a partnership must be paid out of the partnership assets. If an individual partner is convicted of an offence the fine would be paid by the partner as an individual.
  4. For the purposes of proceedings, Schedule 3 of the Magistrates’ Courts Act 1980 applies as it applies in relation to a body corporate.

Supplementary

Section 133: Obligations of confidence etc

  1. Any disclosure of information, document, equipment, or other item which is required or authorised by section 119, section 120 or Schedule 14 does not breach any obligation of confidence owed by the person making the disclosure or any other restriction on disclosure.
  2. Nothing within Part 4 of the Act requires or authorises a disclosure of information which would contravene data protection legislation. However, when considering whether a disclosure would breach data protection legislation, any requirement or authorisation to make such a disclosure under the Act should be taken into account.

Section 134: Consequential amendments relating to Part 4

  1. This section inserts Schedule 15, which makes consequential amendments in relation to the HSSIB.

Schedule 15: Consequential Amendments relating to Part 4

  1. This schedule makes consequential amendments to the following Acts to include references to the HSSIB where appropriate:
    • Public Records Act 1958
    • Public Bodies (Admission to Meetings) Act 1960
    • Parliamentary Commissioner Act 1967
    • House of Commons Disqualification Act 1975
    • Copyright, Designs and Patents Act 1988
    • Employment Rights Act 1996
    • Freedom of Information Act 2000
    • National Health Service Act 2006
    • Health Act 2009
    • Equality Act 2010.

Section 135: Interpretation of Part 4

  1. This section provides definitions that apply throughout Part 4 of the Act.

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