F181 Accepted in Part

Enforcement of the duty Statutory duties of candour in relation to harm to patients

Mid Staffs Inquiry · Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry · Issued 6 February 2013 · Addressed to: Department of Health and Social Care

Source — verbatim from the inquiry

Inquiry recommendation

A statutory obligation should be imposed to observe a duty of candour: On healthcare providers who believe or suspect that treatment or care provided by it to a patient has caused death or serious injury to a patient to inform that patient or other duly authorised person as soon as is practicable of that fact and thereafter to provide such information and explanation as the patient reasonably may request; On registered medical practitioners and registered nurses and other registered professionals who believe or suspect that treatment or care provided to a patient by or on behalf of any healthcare provider by which they are employed has caused death or serious injury to the patient to report their belief or suspicion to their employer as soon as is reasonably practicable. The provision of information in compliance with this requirement should not of itself be evidence or an admission of any civil or criminal liability, but non-compliance with the statutory duty should entitle the patient to a remedy.

Mid Staffs Inquiry, Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry · 6 Feb 2013 Source PDF →

Published evidence summary

Publicly available evidence relating to this recommendation:

- The statutory duty of candour on healthcare providers was enacted as Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Regulation 20 requires registered providers to notify patients (or their representative) when a "notifiable safety incident" — one that has resulted in or could result in death or serious harm — has occurred. The duty came into force for NHS bodies on 27 November 2014 and was extended to all registered providers from April 2015 (SI 2014/2936, Regulation 20).
- Francis recommended a statutory duty of candour on individual registered professionals as well as on providers. The government's response in "Hard Truths" (Cm 8777, November 2013) accepted the duty on providers but stated that the individual professional duty of candour would be addressed through professional regulation rather than statute. The GMC and NMC subsequently strengthened their professional codes to include explicit candour requirements (Hard Truths, DHSC, November 2013).
- The NMC updated its Code in March 2015 to include Standard 14: "Be open and candid with all service users about all aspects of care and treatment, including when any mistakes or harm have taken place." The GMC's "Good Medical Practice" requires doctors to be open with patients when things go wrong. Both regulators can take fitness to practise action against registrants who breach these professional candour duties (NMC Code 2015; GMC Good Medical Practice).
- DHSC's call for evidence on the duty of candour (November 2024) examined whether the current split between a statutory organisational duty and a professional individual duty is effective. Some respondents argued that a statutory duty on individuals as well as providers would strengthen compliance (DHSC Duty of Candour Call for Evidence, November 2024).

Response — verbatim from government

Department of Health and Social Care

The government published "Hard Truths: the Journey to Putting Patients First" (Cm 8777) on 19 November 2013, responding to all 290 recommendations of the Francis Report. This followed an initial response "Patients First and Foremost" in March 2013. Key reforms included a new Chief Inspector of Hospitals, strengthened Care Quality Commission inspection regime, a statutory duty of candour, and the fit and proper person test for NHS directors. Volume 2 (Cm 8754) contains the government's detailed responses to each of the 290 recommendations. See: https://assets.publishing.service.gov.uk/media/5a7cd486ed915d63cc65d167/34658_Cm_8777_Vol_1_accessible.pdf

Department of Health and Social Care · 19 Nov 2013 Written response →

Evidence trail — what's actually happened since

  • 1 Jun 2025 · National Guardian's Office - Annual Data 2024-25 Over 1,400 Freedom to Speak Up Guardians across healthcare organisations in England. 38,000+ cases raised in 2024-25, cumulative total exceeds 142,000 since inception. However, NHS Staff Survey 2024 shows only 71.5% of staff feel secure raising concerns about unsafe practice (stagnant for years), and only 57% are confident their organisation would address concerns. View source → Reasonable Progress
  • 26 Nov 2024 · DHSC - Duty of Candour Review DHSC published findings of call for evidence on statutory duty of candour. 261 responses received. Key finding: 52% of respondents said CQC had not adequately enforced the duty. Many reported it had become a "tick-box exercise". Only 40% thought the purpose was clear and well understood. Final government response still pending. View source → Reasonable Progress
  • 6 Feb 2023 · Academic Review - Ten Years After Francis Research published 2023 marking ten years since the Francis Report found mixed results. Structural and legislative changes largely delivered (duty of candour, FPPR, CQC overhaul, revalidation, Freedom to Speak Up Guardians). However, cultural change not fully embedded; understaffing, fear of speaking up, and poor complaint handling persist in parts of the NHS. View source → Reasonable Progress
  • 1 Apr 2016 · NMC - Nursing Revalidation NMC Revalidation launched 1 April 2016 in direct response to Francis Report. All nurses and midwives must revalidate every three years. Replaced the Post-Registration Education and Practice system. Updated NMC Code published March 2015 strengthened requirements around candour and raising concerns. View source → Confirmed Completed
  • 31 Mar 2015 · NMC - Updated Professional Code (2015) NMC published updated Code of Professional Standards for nurses and midwives (March 2015). Standard 14 specifically requires nurses and midwives to be open and candid with all service users about all aspects of care, including when mistakes or harm have occurred. View source → Confirmed Completed
  • 11 Feb 2015 · UK Government - Culture Change in the NHS Government published "Culture Change in the NHS" (Cm 9009) reporting progress on all 290 recommendations. Key achievements: 19 hospitals placed in special measures; those trusts recruited 109 additional doctors and 1,805 additional nurses; 129 board-level changes made; excess avoidable deaths fell by 450 in less than a year. View source → Good Progress
  • 11 Feb 2015 · UK Government - Freedom to Speak Up Review Sir Robert Francis published Freedom to Speak Up Review on 11 February 2015 with 20 principles and actions. Led to: Freedom to Speak Up Guardians mandatory in all NHS trusts from October 2016; National Guardian's Office established January 2016. View source → Confirmed Completed
  • 27 Nov 2014 · Legislation - Duty of Candour (Regulation 20) Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 20: statutory duty of candour came into force for NHS trusts November 2014, extended to all CQC-registered providers April 2015. Requires providers to notify patients/families of notifiable safety incidents and apologise. View source → Confirmed Completed
  • 19 Nov 2013 · UK Government - Hard Truths Vol 1 & 2 Government published "Hard Truths: The Journey to Putting Patients First" (Cm 8777) in two volumes. Vol 1 set out new actions; Vol 2 provided detailed response to each of the 290 recommendations. Approximately 204 of 290 recommendations were fully accepted. View source → Good Progress
  • 3 Dec 2012 · GMC - Medical Revalidation GMC medical revalidation launched December 2012. All licensed doctors must demonstrate fitness to practise every five years through appraisal and evidence. Francis Report endorsed and recommended strengthening revalidation. View source → Confirmed Completed

Each entry above links to a primary source — gov.uk written statement, consultation response document, or inspection report. The Index does not characterise government intent; it tracks what has been published.

How this page is built

Source and Response are verbatim from primary documents. The Evidence trail records published activity since — written statements, consultation outcomes, inspection findings, parliamentary references. The Index does not paraphrase or characterise intent; it tracks what has been published. Where the evidence is the absence of action (a missed deadline, a slipped timetable), that absence is documented from primary sources rather than inferred.

This recommendation's data is verified periodically against primary sources. The Index is monitored for staleness weekly.