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.

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.

Penny Dash Review (commissioned May 2024) found significant failings at CQC. Health Secretary declared CQC "not fit for purpose". Key findings: one in five services never rated; inspection levels well below pre-pandemic levels; lack of specialist inspector expertise; 5,000 notification-of-concern backlog. CQC consulting on resetting its approach from October 2025.

Learn from Patient Safety Events (LFPSE) service replaced the National Reporting and Learning System (NRLS). NRLS fully decommissioned 30 June 2024. LFPSE has broader coverage including primary care, uses machine learning for analysis and improved trend identification.

HSSIB formally launched 1 October 2023 as independent statutory body under Health and Care Act 2022. Replaced HSIB (non-statutory, established 2016). Has statutory "safe space" protections, powers of entry, inspection and seizure. Conducts system-focused patient safety investigations.

Patient Safety Incident Response Framework (PSIRF) replaced the Serious Incident Framework from Autumn 2023. Shifts from individual blame to system-based learning approaches. Mandatory for all NHS-funded secondary care providers. Part of NHS Patient Safety Strategy (July 2019).

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.

First Patient Safety Commissioner Dr Henrietta Hughes OBE appointed 12 September 2022 under Medicines and Medical Devices Act 2021. Independent champion for patient safety regarding medicines and medical devices.

Clinical Commissioning Groups replaced by 42 Integrated Care Boards from 1 July 2022 under Health and Care Act 2022. ICBs have broader responsibilities for population health, bringing together NHS organisations, local authorities and partners. Implements some Francis recommendations on commissioning integration.

Francis recommended restrictions on contractual clauses that might prevent staff from speaking up. The Freedom to Speak Up Review (2015) addressed this. The government accepted that gagging clauses in NHS contracts should be prohibited. NHS standard contracts now include provisions protecting the right to raise concerns.

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.

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.

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.

New "Fundamental Standards" replaced previous CQC registration requirements from 7 November 2014. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 introduced clearer minimum standards including: person-centred care (Reg 9), dignity (Reg 10), safe care (Reg 12), staffing (Reg 18), good governance (Reg 17), fit and proper persons (Reg 5), duty of candour (Reg 20).

CQC overhauled its inspection regime in response to Francis. Professor Sir Mike Richards appointed as first Chief Inspector of Hospitals (July 2013). New methodology based on five key questions (Safe, Effective, Caring, Responsive, Well-led) rolled out nationally October 2014. Four-tier ratings introduced (Outstanding/Good/Requires Improvement/Inadequate). Specialist expert-led inspection teams replaced generalist compliance model.