Resources
The standards behind the curriculum.
Every module points back to primary sources. Start with the standards; the modules translate them into the decisions you will actually face on a Trust.
Primary sources
Start with the documents that govern the work.
DCB0129
Clinical Risk Management: its Application in the Manufacture of Health IT Systems
NHS Digital / NHS England
Manufacturer-side clinical risk management and Safety Case requirements.
DCB0160
Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems
NHS Digital / NHS England
Deployment-side clinical risk management obligations for NHS organisations.
DTAC
Digital Technology Assessment Criteria for Health and Social Care
NHS England
Baseline assessment across clinical safety, data protection, technical assurance, interoperability and usability.
PSIRF
Patient Safety Incident Response Framework
NHS England
National framework for responding to and learning from patient safety incidents.
ISO 14971:2019
Application of Risk Management to Medical Devices
ISO
The international baseline for risk management in medical devices.
BS/AAMI 34971
Application of ISO 14971 to Machine Learning in AI Medical Devices
BSI / AAMI
Guidance on AI-specific failure modes and risk management.
MHRA
Software and AI as a Medical Device Change Programme
Medicines and Healthcare products Regulatory Agency
The MHRA's evolving regulatory position on software and AI as a medical device in the UK.
ICO
Guidance on AI and Data Protection
Information Commissioner's Office
How UK GDPR applies to AI systems, including DPIA expectations.
Direct links to source documents are deliberately omitted from the MVP: authoritative URLs for several of these standards change without redirect. Search the publisher's site for the current version.
Frameworks at a glance
Twelve frameworks, in one place.
DCB0129
Clinical Risk Management — Manufacturer
Defines the obligations on health IT manufacturers to operate a clinical risk management system and produce a Safety Case.
DCB0160
Clinical Risk Management — Deployment
The deploying organisation's counterpart to DCB0129. Governs how Trusts implement and monitor health IT safely.
DTAC
Digital Technology Assessment Criteria
NHS England's baseline assessment covering clinical safety, data protection, technical assurance, interoperability and usability.
PSIRF
Patient Safety Incident Response Framework
The NHS's approach to learning from patient safety incidents. Replaces the Serious Incident Framework.
ISO 14971
Risk Management for Medical Devices
The international standard for applying risk management across the medical device lifecycle.
BS AAMI 34971
AI Risk Management Guidance
Guidance on applying ISO 14971 to machine learning enabled medical devices, addressing AI-specific failure modes.
MHRA AIaMD
AI as a Medical Device
The MHRA's evolving regulatory approach to software and AI as a medical device in the UK.
UK GDPR / DPIA
Data Protection
Data Protection Impact Assessments where AI processing presents risks to patient rights and freedoms.
NICE ESF
Evidence Standards Framework
NICE's framework for evaluating digital health technologies, including AI-driven tools.
EU AI Act
High-Risk AI Regulation
EU-wide regulation of high-risk AI systems, including health applications. Relevant to UK suppliers operating cross-border.
AMLAS
Assurance of Machine Learning for Autonomous Systems
A structured argumentation-based methodology for assuring the safety of machine learning components.
ECSF
England Clinical Safety Framework
Emerging national framework coordinating clinical safety practice across NHS England.