GDPR
Consent and AI Medical Scribes - Is It Required?
Part 1 of 4 of a series on AI scribes
Dr. Paul Jewell•Feb 19, 2025
Consent and AI Medical Scribes - Is It Required?Clinical Safety
DCB0129
Digital Clinical Safety for Manufacturers
FRAMEWORKEnsure clinical safety
Ensure clinical safety
with DCB0129
compliance
The DCB0129 is a mandated requirement for manufacturers of health IT systems to ensure digital health technologies are safe to use in the NHS. Ensure safe, efficient, and cost-effective deployment of health IT systems by meeting your DCB0129 requirements
Request a demoDCB0129
NHS Digital Clinical Safety for Manufacturers
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How Assuric can help
We can assist you with all aspects of DCB0129 Clinical Risk Management including:
Document management
Create Clinical Safety Case Reports and Clinical Risk Management Plans. Generate documents from templates; automate document completion; set owners, due dates and reminders; collaborate across teams.
Manage multiple projects
Work across multiple complex projects. Avoid duplication of work by linking hazards, causes and controls across projects.
Hazard Log
Best-in-class hazard log designed by Clinical Safety Officers and specialised for DCB0129. Manage hazards, causes, controls and evidence across multiple projects. Referenced to the implementation guidance throughout.
Manage clinical incidents
Manage clinical incidents in line with the implementation guidance. Assign owners and link across hazards and controls.
Staff clinical safety training and compliance
In-built clinical safety training modules, combined with automated tracking and reminders to ensure compliance.
Clinical Safety Officer support
Expert support from our team of Clinical Safety Officers ranging from ad-hoc advice to full managed named external Clinical Safety Officer consultancy.
Map to other frameworks
Use intelligent automation and AI to avoid duplication of work, easily meeting NHS DTAC requirements. Easily share transferred controls with NHS teams and collaborate across clinical safety cases.
FAQS
Frequently Asked Questions
Get in touch if we haven’t answered your question below, we are always happy to help!
What is DCB0129?
DCB0129 is a mandatory UK clinical risk management standard that all manufacturers of digital health technologies and health IT systems must comply with.
Do I need to comply with DCB0129?
Yes, all suppliers of digital health technologies or health IT systems must comply with DCB0129. NHS organisations will require evidence of compliance before procurement or implementation.
What is the difference between DCB0129 and DCB0160?
DCB0129 and DCB0160 are overlapping clinical safety standards. DCB0129 applies to manufacturers or suppliers of digital health technologies or health IT systems. DCB0160 applies to the NHS organisations implementing them.
What is a Clinical Safety Officer (CSO) and do we need one?
A Clinical Safety Officer (CSO) is a clinician, currently registered with a professional body, who is appropriately trained in clinical safety. In order to become compliant with DCB0129, you must have a nominated individual to act as your CSO. They can be internal or external - we provide expert external CSOs as required.
Who can be a CSO?
A Clinical Safety Officer must:
- Be a suitably qualified and experienced clinician
- Hold a current registration with an appropriate professional body relevant to their training and experience
- Be knowledgeable in risk management and its application to clinical domains
- Make sure that the processes defined by the clinical risk management process are followed
We work with external CSOs who are experienced and confident using our platform to ensure you are compliant as quickly as possible.
testimonials
What Our Customers Say
Compliance is complex, but our AI tools simplify it. Discover features to stay ahead of regulations.
Kelly Klifa
CEO at Heim
Assuric has been transformative for Heim as we looked to achieve DCB0129 and DTAC compliance. The platform is easy to use, and the AI tools and automated reminders make previously dreaded compliance tasks a breeze. Paul and Matt supported us every step of the way.
Katie Baker
Director UK & Ireland at Tandem
Assuric has been fantastic in helping us quickly and safely navigate regulatory compliance in the UK. From completing Cybersecurity requirements to DSPT, DCB0129, and DTAC, the team was supportive, extremely knowledgeable, and the platform made everything quick and straightforward. A separate regulatory company we consulted at the beginning even remarked on how quickly we achieved compliance!
Maks Kozarzewski
COO at VitVio
We couldn't speak highly enough of both the Assuric team and the platform itself, which is incredibly easy to use, and with the skill and hardworking nature of the Assuric team. They've been a key component in accelerating our progress and deployments!
Maja Mazur
CEO at Healthnix
Assuric has been such a blessing in getting our DTAC and GDPR compliance done - completing all the documentation and deciding what needs to be done whilst running the business is very hard, but the team really helped us through that. The platform is easy to use, helps keep track of things and it even allows us to coordinate all the team training easily. Highly recommend them!
Dean Mawson
Clinical Director at DPM
Assuric streamlines the process of achieving and maintaining compliance with DCB0129 standards for digital health technologies. The user-friendly interface simplifies collaboration across multidisciplinary teams, while the built-in templates and workflows save significant time and effort during compliance projects. Assuric’s ability to centralise documentation and provide real-time visibility into project progress is particularly beneficial for Clinical Safety Officers and digital project teams, enhancing both efficiency and assurance.
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Why data sharing matters under GDPR - accountability and finesMake your life easier
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