Policy paper

Health and Care Bill: Health Services Safety Investigations Body

Updated 10 March 2022

The General Medical Council, in relation to the HSSI Bill’s Second Reading in 2019, said:

We support the creation of a ‘safe space’ approach to investigation. This is consistent with our guidance to doctors about their responsibilities to learn from mistakes and reflect on their practice, and their duty to take part in systems of quality assurance and quality improvement to promote patient safety.

This fact sheet explains how the government plans to establish the Health Services Safety Investigations Body (HSSIB) as an independent statutory body with the function of investigating incidents that occur in England during the provision of health care services which have, or may have, implications for the safety of patients.

Background

The Health Services Safety Investigations Body will build on the work of the Healthcare Safety Investigations Branch (the HSIB) which became operational in April 2017 as part of NHS Improvement, to conduct high-level investigations into patient safety incidents in the NHS. The new body will conduct investigations and its remit will be extended to include the independent sector too.

There are calls for HSIB to be put on an independent statutory footing, bringing forward earlier proposals which the Health Service Safety Investigations (HSSI) Bill introduced in October 2019 to establish an independent statutory body to investigate incidents which occur in England during the provision of health care services which have, or may have, implications for the safety of patients (qualifying incidents).

The proposed HSSIB provisions have now been brought into the Health and Care Bill. The clauses are intended to establish an independent executive non-departmental public body to investigate qualifying incidents, with the right powers to investigate and promote system learning.

Independence as a concept is fundamentally important to HSSIB as it will be a crucial way of ensuring that patients, families and staff have trust in its processes and judgements. Investigation reports will make recommendations, which most recipients are required to respond to within a specified timescale.

We are responding to concerns raised during the HSSI Bill’s first parliamentary passage and have amended the Bill provision to extend HSSIB’s remit to cover healthcare provided in and by the independent sector. In addition, we are also introducing a power to enable the Secretary of State to direct HSSIB to investigate a particular qualifying incident or groups of qualifying incidents.

This is a world-leading innovation in patient safety and underlines the government’s commitment to reducing patient harm by improving the quality of health investigations in England and sharing that learning more widely.

What the Bill will do

The proposed changes will:

  1. Establish an independent investigations body on a statutory footing. HSSIB will be established as a new independent executive non-departmental public body, with the function of investigating qualifying incidents. These are incidents that occur in England during the provision of health care services which have, or may have, implications for the safety of patients. Independence is fundamental to the HSSIB as it will help ensure that patients, families and staff have trust in its processes and judgements. The HSIB is part of NHS Improvement which will be merged with NHSE in the Bill, so the Bill provides transitional arrangements to ensure the HSIB can continue to carry out its functions between the merger and the HSSIB becoming fully operational.

  2. Strengthen ‘safe space’ powers. The new HSSIB will conduct investigations using ‘safe space’, which prohibits, on a legal basis, the unauthorised disclosure of protected material. Protected material is any information, document, equipment or other item which is held by the HSSIB, for the purposes of an investigation and has not already been lawfully made available to the public. The legislation puts ‘safe space’ on a statutory footing and creates three criminal offences relating to unauthorised disclosure of protected material.

  3. Introduce new legal powers of entry and powers to obtain information. It is expected that NHS and independent sector organisations will cooperate fully with the HSSIB’s investigations and benefit from the shared system learning that results. The Bill provides powers for investigators, where necessary for the purpose of an investigation, to enter and inspect premises in England. Inspectors may also inspect and seize documents, equipment or other items at the premises. In certain circumstances, an investigator may, with notice, require any person to answer questions or provide specified documents, equipment or items.

  4. Encourage the spread of a culture of learning within the NHS. The HSSIB will look to promote better standards for local investigations and improve their quality and effectiveness. To this end, the HSSIB will disseminate information about best practice and standards to be adopted. It may provide advice, guidance and training to organisations in connection with an investigation, upon request.

How these provisions help improve public confidence

The HSSIB will be one of the first independent healthcare bodies of its kind, leading the way in investigating for the purpose of learning, not blaming. These proposals align with the recommendations made in Learning not blaming (2015).

The HSSIB will establish ‘safe space’ protections, prohibiting the unauthorised disclosure of protected material. These provisions encourage all participants to be completely candid with the information they share, enabling more thorough investigation into what went wrong. The legislation will allow investigations to be carried out independent of the NHS and government. This will give the public confidence in the HSSIB’s investigation process and their ability to deliver impartial conclusions and recommendations.

The HSSIB’s investigations and reports will not assess or determine blame, civil or criminal liability or whether action needs to be taken in respect of an individual by a regulatory body. Instead, the HSSIB’s investigations identify risks to the safety of patients and address these risks by facilitating the improvement of systems and practices in the provision of health care services in England.

Its remit will cover health care provided by the independent sector as well as by the NHS, to enable more thorough investigation, so the HSSIB’s investigations have the potential to improve public confidence in the care they receive.

Further information

Learning not blaming: the government response to the Freedom to Speak Up consultation, July 2015.

The government response to the Report of the Joint Committee on the Draft Health Service Safety Investigations Bill, December 2018

Health Service Safety Investigations Bill, October 2019

Integration and Innovation White Paper, February 2021