Digital Clinical Safety / Health IT Innovation · DCB 0129 · DCB 0160 · ISO 14971 · AI Assurance · Clinical & Non-Clinical Career Pathways

Safe digital health
requires expert clinical
risk management

ORTHON provides expert digital clinical safety training, safety readiness, technical file support, and tools for NHS organisations and health technology manufacturers navigating the complex landscape of digital clinical safety.

Explore our services How we work
Grounded in
DCB 0129 / DCB 0160 ISO 14971 AI / SaMD Assurance CPD Certified

Our mission

Where digital innovation meets clinical safety.

Technology is transforming healthcare at pace. New systems, smarter devices, AI-driven tools, emerging technology — the opportunities are extraordinary. But with innovation comes risk. And in clinical environments, risk has consequences.

We help you move forward with confidence — building the safety culture, regulatory frameworks and risk management strategies that let you innovate without compromise.

What we do

Training, tools and assurance for genuine clinical safety

We help organisations build lasting internal capability through structured training, AI-powered tools, and expert assurance — making safe digital care the default, not the exception.

01
Digital Clinical Risk Management Training
Part 1 and Part 2 Clinical Risk Management courses, available individually or as a bundle — structured pathways that build lasting capability at every level.
02
Applicability Checker
A guided DCB 0129 / 0160 applicability decision tool — know your obligations in minutes, not days. Coming soon.
03
ORTHON Safety Readiness Review
Expert review of your organisational processes, documentation and governance — assessed by National leads in digital clinical safety. Enquire for more information.
CPD Certified Continuing Professional Development

Training programmes

Clinical risk management, in two parts

Our Clinical Risk Management courses are available as standalone programmes or as a discounted bundle — designed for individuals and organisations at every stage of their safety journey.

CPD Certified — The CPD Certification Service
Clinical Risk Management · Part 1 · 1 Day
Applied Clinical Risk Management
For practitioners of digital clinical safety including clinical safety officers, clinical safety co-ordinators, and safety engineers — clinical and non-clinical backgrounds welcome. If you work in any phase of a health technology product lifecycle, this course is for you.
£400 per person
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What's covered
  • Recap of clinical risk management theory including DCB standards
  • Clinical risk management process, documentation and incident management
  • First step in practical application of theory through hazard assessment workshop
  • Clinical Safety Case Reports
  • Exploration of human factors
  • Testing
  • Assuring AI and clinical safety
  • Cyber
Book this programme Full course details
Clinical Risk Management · Part 2 · Advanced Modules
Clinical Risk Management in Practice
For those with Part 1 knowledge seeking deeper expertise in practical implementation of digital clinical safety. Already completed a recognised Part 1 practitioner course elsewhere? You can join at Part 2.
£400 per person · standalone
View programme›
What's covered
  • How to develop and structure your clinical risk management system
  • Deep dive into writing a clinical risk management system
  • Deep dive into writing project-specific clinical risk management plans
  • Running a hazard assessment workshop
  • Hands-on authoring of clinical safety case reports, tailored to the true size, scale and complexity of the system. Proportionate risk methods.

    We don't just document safety — we teach you how to think about it, equipping you to identify, assess and control evolving digital ecosystems that now often involve system of systems workflows.
Book this programme Full course details
Part 1 + Part 2 Bundle · Best Value
Both programmes together — best value for the full clinical risk management journey
£650 per person Save £150 vs standalone
Book Part 1 to start the bundle
New Pathway · Non-Clinical
The Safety Engineer Pathway

A structured route into clinical safety for professionals without a clinical background. We know this path — because we helped build it. Complete pathway to Clinical Safety Co-ordinator or Safety Engineer.

Book this pathway Full pathway details
Who this is for
  • Non-clinical members who have a passion for Digital Health Technology
  • IT professionals embedded in NHS or health tech environments
  • Risk and governance specialists moving into clinical safety roles
  • Anyone seeking a named, credentialled route to Clinical Safety Co-ordinator or Safety Engineer
Closed Courses · Organisations
Training your whole team? We offer reduced rates for closed courses delivered exclusively for your organisation — minimum 10 attendees.
Enquire about closed courses

Our approach

Practitioner-led. Rigorous. Practical.

We don't deliver generic compliance checklists. Our work is grounded in real NHS experience and designed to build lasting internal capability.

Grounded in practice

Our team has operated within NHS digital clinical safety — not just advised on it. That distinction matters when the stakes are patient outcomes.

Standards-aligned

Every engagement is anchored to DCB 0129, DCB 0160, and ISO 14971.

Built to transfer

Our training and advisory work is designed to leave organisations with the knowledge and tools to sustain safe practice independently.

Meet the founders

National experience.
Practitioner-led.

Our founders have shaped clinical risk management at a national level — contributing to the development of the DCB standards and providing assurance across multiple national health systems and services.

Rudi Hennessy
Rudi Hennessy
Co-founder

Senior Safety Engineer with over a decade in digital clinical safety at a national level. Author of national e-learning on DCB 0129 and DCB 0160 and continues to shape national training and standards.

Mike Anderson
Mike Anderson
Co-founder

Safety Engineering Manager with over 20 years' experience shaping guidance, assurance, standards and best practice in digital clinical safety. Brings deep practitioner expertise and a clear sense of what good looks like.

Who we work with

Health technology
manufacturers and NHS providers

Whatever your role in the digital health ecosystem, we bring the same rigour and the same commitment to building safety capability that lasts.

Health Tech Manufacturers

DCB 0129 compliance support, hazard assessment, CSCR documentation, and training for clinical safety officers and development teams.

NHS Organisations

DCB 0160 deployment safety, procurement assurance, provider-side clinical risk management plans, and board-level AI governance.

International Health Systems

Experts in embedding safety standards across borders — supporting health systems worldwide with system-wide frameworks, clinical risk management systems, and the governance structures needed to make safe digital health the norm.

Coming soon · Applicability Checker
Know your DCB obligations in minutes

A guided decision tool that walks you through DCB 0129 / 0160 applicability — built on a decade of real-world clinical safety review. Designed for health tech teams who need clarity, fast.

Step-by-step questions tailored to your product and use case
Clear, evidenced output you can share with your CSO and regulators
Free to use at launch — no commitment required
Applicability Checker
Step-by-step DCB 0129 / 0160 applicability decision tool. Register your interest and we'll let you know the moment it's live.
Coming soon
Register interest →

ORTHON Safety Readiness Review

Independent assurance, before it matters

A structured review of your organisational processes, documentation and governance — delivered by National leads in digital clinical safety. Designed to give you a clear picture of where you stand and what's needed next.

01
Evaluating submissions against relevant artefacts
02
Producing a structured output
03
Providing a clear outcome with rationale
04
Identifying required actions for clinical and clinical safety SMEs
Ready to commission a review?
Contact us to discuss your scope, timelines and how a Safety Readiness Review fits your organisation.
Learn more & enquire

Frequently asked questions

DCB 0129, DCB 0160 and ISO 14971

Straight answers to the questions we're asked most by NHS teams and health tech manufacturers. Read our full DCB 0129 vs DCB 0160 guide for more detail.

What is DCB0129?
DCB0129 ("Clinical Risk Management: its Application in the Manufacture of Health IT Systems") is the NHS clinical safety standard that applies to manufacturers of health IT systems. It requires a Clinical Safety Officer to oversee clinical risk management activities and produce a Clinical Safety Case Report before a system is released or updated.
What is DCB0160?
DCB0160 ("Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems") is the companion NHS standard for organisations deploying and using health IT systems. It requires the deploying organisation to manage clinical risk arising from how a system is configured and used in their specific care setting.
What's the difference between DCB0129 and DCB0160?
DCB0129 applies to the manufacturer building or changing a health IT system; DCB0160 applies to the health or care organisation deploying and using it. A single product often needs assurance under both — the manufacturer's Clinical Safety Case under DCB0129, and each deploying organisation's own Clinical Risk Management Plan under DCB0160.
Who needs digital clinical safety training?
Clinical Safety Officers (CSOs), Clinical Safety Coordinators, safety engineers, and anyone involved in specifying, building, procuring or deploying health IT systems in the NHS or wider health technology sector — both clinical and non-clinical professionals.
Do AI-enabled health technologies need clinical safety assurance?
Yes. AI-enabled decision support and SaMD (Software as a Medical Device) still carry clinical risk and typically fall under DCB0129/DCB0160 if used in NHS settings, and under ISO 14971 risk management requirements if the product is a regulated medical device. AI introduces additional considerations such as model drift and explainability that need to be captured in the risk management file.
How much does ORTHON's clinical risk management training cost?
Applied Clinical Risk Management (Part 1) and Clinical Risk Management in Practice (Part 2) are each £400 per person standalone, or £650 per person as a bundle. Closed courses for organisations training 10 or more people are available at reduced rates.
How does DTAC relate to DCB0129 and DCB0160?
DTAC (the Digital Technology Assessment Criteria) is the NHS framework suppliers are assessed against before their product can be used in health and care settings. Its "Clinically Safe" criterion is satisfied by evidencing DCB0129 compliance — so preparing your Clinical Safety Case and clinical risk management documentation is a direct route to passing that part of a DTAC assessment.

"The digital health system must make safe care the path of least resistance — we give you the tools to do the right thing at the right time."

ORTHON — Digital Clinical Safety / Health IT Innovation

Ready to build genuine clinical safety capability?

Get in touch View training

Free Resources

Free resources from our experts

Free Toolkit
Top Management Toolkit
An interactive guide to DCB 0129 / 0160 governance for NHS boards and senior leaders
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Substack
Rudi Hennessy
Insights on digital clinical safety, AI assurance, and the future of health technology
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LinkedIn
ORTHON
News, updates and perspectives on digital clinical safety
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