Statutory and Professional Duties duty of candour in health

The regime operates on two statutory layers and one dormant layer. The first layer is Regulation 20 — an organisational duty on CQC-registered providers triggered by a 'notifiable safety incident' (death, severe, moderate or prolonged psychological harm of ≥28 days), requiring in-person notification, factual account, advised next steps, apology and written follow-up 1. The second is the professional duty in the codes of practice of the GMC, HCPC, NMC and other regulators — overseen at meta-level by the Professional Standards Authority (the April 2026 PQ to DHSC probed how candour principles are embedded in GMC and HCPC investigative conduct). The third, dormant layer is the NHS Redress Act 2006, which authorises an out-of-court redress scheme combining apology, explanation, report-on-remedial-action AND compensation 2 — never commenced in 19 years, leaving Regulation 20's narrower process-only architecture as the operative duty. Enforcement is CQC-led; the November 2024 PQ confirmed CQC's two-track architecture of Fixed Penalty Notices or court prosecution 3. The 2009 Complaints Regulations sit adjacent, providing the principal route through which candour failures surface as complaints to a designated responsible person and complaints manager 4. SI 2026/495 — the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2026 — is the most recent live amendment, approved by both Houses in April 2026 567. A separate workstream on regulating NHS managers, with the July 2025 consultation response 'Leading the NHS', proposes a professional duty of candour for managers to plug the manager-accountability gap in the existing organisational duty 8.

Three workstreams have been live in the last six months. First, SI 2026/495 — the Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2026 — was made on 8 May 2026 1 after Lords Chamber consideration on 21 April 2026 2, the Commons Delegated Legislation Committee on 15 April 2026 (sponsored by PUSS Dr Zubir Ahmed) 3, and Lords Grand Committee on the same day 4. April 2026 PQs from Olly Glover and others pressed for a voluntary-sector exemption for mountain rescue teams 56. Second, the Public Office (Accountability) Bill reached its Third Sitting on 2 December 2025 with clause-by-clause consideration including amendments on intelligence-services scope and the duty of candour 7; the Lords Library briefing of 18 November 2025 confirmed the Government's commitment to the public-servant duty 8 and the Commons Library updated CBP-10424 on Bill progress in April 2026 9. Third, on 21 July 2025 the Government published its consultation outcome 'Leading the NHS: proposals to regulate NHS managers' — including a possible professional duty of candour for managers — followed by a Commons debate the same day 10.

Three forward markers dominate. First, DHSC's final response to the statutory duty of candour review, distinct from the January 2025 Health and Social Care Committee Expert Panel Government Response: the November 2024 call for evidence closed over 18 months before the most recent thread events 1, and the call-for-evidence findings already in circulation reported broadly underwhelming impact 2. The final response will define whether the Government strengthens Regulation 20's threshold, adds an individual-practitioner statutory layer, or relies on parallel Hillsborough-Law architecture instead. Second, the passage of the Public Office (Accountability) Bill: clause-by-clause consideration on 2 December 2025 surfaced live questions on intelligence-services scope and the boundaries of the public-official duty 3, and the interaction between the cross-sector duty and Regulation 20 in healthcare contexts has not been clarified — overlapping enforcement (CQC vs whatever body enforces the Bill's duty) is a live design question. Third, follow-through on the NHS manager regulation track: the July 2025 'Leading the NHS' consultation response opens the door to a professional duty of candour for managers 4, plugging the gap left by Regulation 20's organisation-only architecture. Watch also for the dormant NHS Redress Act 2006 5 — the Government has had legislative authority for an apology-plus-compensation scheme for 19 years and has chosen not to commence it, and the duty-of-candour review may force that choice back onto the agenda. Finally, CQC enforcement-rate transparency: the November 2024 PQ confirmed FPN-or-prosecution as the architecture 6, but no independent audit of CQC's prosecutorial track record under Regulation 20 is on the thread.

The regime's main credibility risk is the gap between statutory architecture and operational impact, evidenced by DHSC's own call-for-evidence findings that the duty's first-decade impact has been broadly underwhelming 1. A second risk is the regulatory-overlap question: the Public Office (Accountability) Bill introduces a cross-sector public-official duty 2 that will sit on top of Regulation 20 in healthcare contexts without (on the current corpus) any published clarification of which duty bites first, who enforces what, and whether the Bill changes CQC's prosecutorial role. A third risk is the dormant NHS Redress Act 2006 3: 19 years uncommenced is itself a regime-credibility signal, given that the 2006 Act's apology-plus-compensation architecture would arguably address much of what the call for evidence found lacking. Inferred from corpus gap: the absence of an independent NAO or Public Accounts Committee review of CQC's Regulation 20 prosecution record means the FPN-vs-prosecution balance and the enforcement-frequency picture cannot be independently audited from the events on this thread.