Ongoing safety assurance

Ongoing CSO services

Named Clinical Safety Officers or on-demand support for your in house team to oversee the compliant and safe use of digital tools in your organisation.

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Why you might need this

As healthcare organisations adopt more digital tools and these tools become more technically sophisticated, ongoing clinical safety oversight becomes harder to sustain internally. External CSO support is often required to address:

  • Internal capacity constraints
  • Internal expertise limits (e.g. for AI tools)
  • Multiple concurrent deployments
  • High risk products
  • Imminent CQC inspections
  • Inconsistencies across a PCN or ICB

Ongoing CSO services

A retained service that keeps you safety compliant through product updates & incidents via named CPO services or support for your internal team.

This service is offered in one of two ways:

Named CSO service

A dedicated Clinical Safety Officer for your organisation, filling expertise or bandwidth gaps so you can deploy and maintain digital health technologies safely.

Your named CSO takes responsibility for maintaining DCB0160 compliance for one or more products, providing ongoing oversight as your digital landscape evolves.

What’s included:

  • Clinical safety ownership
  • Governance & decision-making
  • Risk and incident oversight
  • Release sign-off (CATR)
  • Regulatory interface

What this enables:

  • Faster, safer implementation
  • Continuous compliance
  • Clear accountability
CSO support on demand

Expert support on demand for your internal CSO, giving them the confidence and backing to manage compliance across complex or multiple digital health technologies.

What’s included:

  • On-demand advice
  • Complex case support
  • Documentation review
  • Incident input
  • Second opinion

What this enables:

  • Reduced bottlenecks
  • Increased confidence
  • Scalable safety function
  • Fast upskilling of your safety team

What you can expect

Whether you choose a named CSO or support for your existing one, both services cover:

Incident reviews
Maintenance of DCB0160 through product updates
Support with integrated governance and audit
CQC ready documentation
Annual governance review meeting (named CSO service only)
Dedicated time every month

Why Curistica?

Real world expertise

Our team includes clinicians with frontline experience, so we design processes and controls that work in real practice settings.

Inspection-ready

We make sure your digital health technologies are understood, documented, and defensible, so you’re prepared for inspection.

Care & optimism

We care about the future of digital health, and bring energy and creativity to solving problems, not slowing you down.

Peer-reviewed research

We co-author peer-reviewed research assessing NHS digital health technologies

Right-size compliance

We right-size compliance: pragmatic, proportionate, and defensible - prioritising real risk over paperwork and performative controls.

PCNs & networks

We work at scale across PCNs and networks, reducing cost per practice

Curistica, led by digital health superstar Dr Keith Grimes, have been incredibly supportive of the BiteLabs Healthtech team. I’m in awe of their deep knowledge of digital health and the speed at which they work.
Dr Zach Hana
,
CEO & Founder of Biteworld

How can we help?

Book a call to discuss your digital health safety needs and how we can best support your organisation, in 20 minutes

Book a call

CSO services

FAQs

What is a Clinical Safety Officer (CSO)?

A Clinical Safety Officer (CSO) is a suitably qualified and experienced clinician, registered with a professional body (e.g. GMC, NMC, HCPC), who is responsible for overseeing clinical risk management for digital health technologies. They must have completed recognised training, have the expertise to assess and manage clinical risk in practice, and have authority within the organisation to ensure DCB0129 processes are implemented and maintained.

Does our organisation need a CSO?

Yes. Much like a Data Protection Officer (DPO), your organisation must have a named Clinical Safety Officer (CSO) responsible for overseeing clinical safety activities. This is required to meet NHS clinical safety standards under Section 250 of the Health and Social Care Act 2012. The role can be shared across organisations or provided externally.

What training does a CSO need?

A CSO must be a suitably qualified and experienced clinician. This includes completing recognised clinical safety training and having sufficient technical understanding of the systems being assessed. However, training is only a minimum requirement; effective clinical risk management also depends on experience and the ability to make sound judgements, often developed under the guidance of a more experienced CSO.

Does every practice need a CSO of their own?

Each organisation must have access to a named CSO to manage clinical safety activities, but this does not need to be a dedicated individual per practice. The role can be shared across organisations or provided externally.

My practice can't afford a CSO? Can you serve our PCN instead?

Yes. We can act as CSO across multiple practices within a PCN, providing a cost-effective and consistent approach to clinical safety.