ISO 42001 for UK Healthcare: A Practical Guide to AI Governance, Assurance and Accreditation

Artificial intelligence is transforming the National Health Service. Governance has not kept pace. This book closes that gap. NHS trusts, integrated care systems, and health technology suppliers are deploying AI across diagnostic imaging, clinical decision support, operational management, and patient-facing services at a scale and speed that governance arrangements in most organisations are not equipped to manage. Regulatory expectations are hardening, certification bodies are active, and the question is no longer whether your organisation needs a formal AI management system, but how quickly you can build one that will withstand scrutiny. ISO 42001 for UK Healthcare is the definitive practical guide to implementing, operating, and achieving certification to ISO 42001:2023, the international standard for AI management systems, in a healthcare context. Written for NHS board members, clinical safety officers, chief information officers, procurement leads, digital transformation teams, and the technology suppliers who serve them, this book provides both the intellectual framework for understanding why AI governance matters and the step-by-step implementation guidance for building a system that works. What this book covers: Across twenty-six chapters and eleven practical appendices, the book addresses the complete lifecycle of healthcare AI governance: The UK and European legislative landscape governing healthcare AI, including UK GDPR, the EU AI Act, MHRA Software as a Medical Device requirements, DCB0129, DCB0160, and DTAC 2.0 How to conduct a comprehensive AI estate review, including the identification and governance of shadow AI, purchased AI, research AI, and AI embedded within enterprise systems The technology types that governance must address: large language models, retrieval-augmented generation, ambient voice technology, medical imaging AI, and autonomous agentic systems A structured approach to gap analysis, stakeholder analysis, and impact analysis using ISO 42001 and ISO 42005:2025 The complete ISO 42001 implementation framework, including all 38 Annex A controls, the Statement of Applicability, and practical guidance on control implementation for NHS organisations and suppliers Bias identification, performance validation, and continuous monitoring as patient safety obligations Cybersecurity, prompt security, and data ingestion controls at the intersection of ISO 42001 and ISO 27001 Internal audit design, certification audit preparation, and surveillance audit maintenance The path to UKAS-accredited certification and how to communicate assurance to commissioners, regulators, and the public The book draws on three internationally recognised governance frameworks as its analytical foundation: ISO 42001:2023, the NIST AI Risk Management Framework, and the OECD AI Principles. It integrates these frameworks with the specific legislative, regulatory, and operational realities of UK healthcare, making it the only resource that connects international AI governance standards directly to the NHS context. Practical tools accompany every stage of implementation: an AI System Register template, a Governance Readiness Self-Assessment, a clause-by-clause Gap Analysis instrument, a Stakeholder Analysis Matrix, a Legislative Reference Summary, alignment maps to DCB0129/DCB0160 and DTAC 2.0, a full Glossary, a Statement of Applicability template, and an integrated comparison of ISO 42001 with ISO 9001, ISO 27001, ISO 14001, and ISO 13485.