Assigned to you
Assigned to others
In progress — updating from current CSO activity
Finalised & sent
Version history
| Pack | Version | Date | Author | Change note | Status | |
|---|---|---|---|---|---|---|
| SafePredict — DCSG | v0.9 | 10 Jun 2026 | A. Whitfield (CSO) | F01–F02 critical findings added from revalidation assessment | Draft | |
| SafePredict — DCSG | v0.8 | 04 Jun 2026 | A. Whitfield (CSO) | 30-day safety monitoring snapshot refreshed | Superseded | |
| DermTriage — Programme Board | v2.0 | 02 Jun 2026 | A. Whitfield (CSO) | Vendor remediation plan condition added; finalised & sent | Sent | |
| ED Flow — DCSG | v1.0 | 21 May 2026 | A. Whitfield (CSO) | Revalidation evidence pack finalised & sent | Sent | |
| Falls Risk — Quality | v1.2 | 28 Apr 2026 | A. Whitfield (CSO) | Ward reconfiguration population change documented | Sent |
Step-by-step guidance on whether DCB0129 and DCB0160 apply to your system — the first question every deployment should answer.
MHRASoftware Flowchart — Is it a Medical Device?MHRA guidance for stand-alone software and apps (incl. IVDs) — determines whether your software qualifies as a medical device.
NHS EnglandDCB0160 & DCB0129Clinical risk management standards for deploying organisations and manufacturers — the backbone of every lifecycle gate.
Patient Safety CommissionerPatient Safety CommissionerChampion for patients on medicines and medical device safety — putting patients at the heart of decisions.
NHS EnglandAI DictionaryShared definitions for AI terminology — keeps committee language consistent across the organisation.
NHS EnglandAI Knowledge RepositoryA–Z of national AI guidance, case studies and assurance resources for health and care.
NHS EnglandLFPSELearn from Patient Safety Events — the national service every vikela incident report aligns to.
MHRA · June 2026AI Airlock Phase 2 ReportPMS, PCCPs, intended purpose as a lifecycle obligation, and human oversight as a degrading variable.
MHRA / PHG FoundationPMS & Continuous Monitoring WorkshopIncludes the Newton's Tree FAMOS case study: inference values, AI/human agreement, data input quality.
MITAI Risk RepositoryThe taxonomy behind vikela's risk categorisation — also used in the UK Healthcare AI Safety Registry.
Open prototypeUK Healthcare AI Safety RegistryWhere vikela incident learning is shared — LFPSE-aligned, so the whole system learns, not just one Trust.
Br J Radiol · 2023Black box no moreThe peer-reviewed scoping review that underpins vikela's four assurance pillars — fairness, transparency, trustworthiness, and accountability. Stogiannos et al., DOI: 10.1259/bjr.20221157.
BSIBS 30440:2023Validation framework for AI in healthcare — anchors pilot and revalidation gate checks.