The triple aim duty on health bodies includes better quality of health services for all individuals. The White Paper therefore introduces a number of measures aimed at improving patient safety and quality including legislative proposals for the Healthcare Safety Investigations Branch (HSIB), new medical registries run by the Medicines and Healthcare products Regulatory Agency (MHRA) and a statutory Medical Examiners role.

HSIB becomes HSSIB

HSIB will become the Health Services Safety Investigations Body (HSSIB) an independent body which will investigate incidents which have or may have implications for the safety of patients in the NHS and will support learning. 

Currently HSIB conducts high-level investigations into patient safety incidents in the NHS with the aim of reducing risk, and improving safety.   The White Paper proposes legislation for HSIB to be put on a statutory footing within the Health and Care bill, bringing forward earlier proposals the Health and Safety Services Investigation (‘HSSI’) Bill introduced in October 2019 to establish an independent statutory body to investigate serious healthcare incidents. 

The aims of HSSIB appear primarily to be:

  • Investigate incidents in a safe space where NHS staff can raise concerns without fear of reprisal, so that patient safety can be improved;
  • To promote a culture of safety and learning; and
  • Ensure independence which is crucially important to gain patient and family confidence and trust during an investigation.

The proposals for HSSIB are set out in Annex A of the White Paper which addresses key concerns, issues and messages, in particular:

  • Initially there had been concerns about patient safety for those on a privately funded care pathway. This has been addressed and HSSIB will continue the work of HSIB with an extended remit to cover healthcare provided in and by the independent sector.
  • The Secretary of State for Health and Social Care can require HSSIB to investigate particular qualifying incidents or groups of incidents.
  • It is envisaged the legislation will specifically prohibit disclosure of information held by HSSIB in connection with its investigatory function, which will be key to HSSIB investigations being a safe space. Participants can provide information in confidence and can speak openly and candidly with the investigators.
  • A safe space will encourage the spread of a culture of learning within the NHS, enabling HSSIB to provide advice, guidance and training to organisations and promote better standards of care.
  • There will be limited circumstances to be set out by the Secretary of State in due course, where prohibition on disclosure will not apply. The practical application of this will undoubtedly be the subject of great interest and scrutiny with the detail requiring careful consideration going forward.

Overall the aim of the legislation is undoubtedly to enshrine transparency and accountability to the public and patients, to be embedded into the structure and culture of the NHS.

Medicines and Healthcare products Regulatory Agency (MHRA) - New Medical Registries

MHRA is the UK’s regulator of medicines, medical devices and blood components for transfusion. As part of the proposals aimed at improved patient safety, the White Paper contains proposals for new UK wide medicines registries to be established and operated by the MHRA. The Registries will be a medicines information system, gathering key data from the NHS and private providers regarding their use and safety. Whilst currently the MHRA can request data from private companies, the aim is that the registries will result in speedier identification of issues of clinical effectiveness or concerns, promoting patient safety and earlier investigation and action.

Medical Examiners System

The White Paper proposes a new statutory Medical Examiner system, the aim of which is once established for medical examiners to independently scrutinise all deaths across England and Wales which do not fall within the remit of the Coroner. In other words, all deaths will either be reviewed by the Coroner or a Medical Examiner once the system is up and running. An amendment to the Coroners and Justice Act 2009 is proposed, which will mean that NHS bodies rather than Local Authorities will appoint the Medical Examiners. The White Paper states:

“The medical examiner system will improve the accuracy of the cause of death and subsequently mortality statistics and will increase transparency for the bereaved and help deter criminal activity and poor practice”


To find out more about the White Paper and how it could affect your organisation, please visit our ICS webpage.

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