Clinical safety assurance for launching or updating digital health products to meet NHS expectations and scale with confidence.
As digital health products mature, structured clinical safety work becomes essential. DCB0129 is required for NHS sales and is emerging as a marker of safer, more trusted products across the public and private sector. Teams typically seek support for:
Fast and product-informed DCB0129 compliance for building safe, customer-ready digital health products.
For a single product or major feature, we will deliver:
We work across healthtech and care delivery, so understand both how products are built and how they are actually used, and what your customers need from you.
We’ve built healthtech products ourselves, so know how to use compliance as an enabler and accelerator, not a blocker.
We care about the future of digital health, and bring energy and creativity to solving problems, not slowing you down.
We co-author peer-reviewed research assessing NHS digital health technologies
We right-size compliance: pragmatic, proportionate, and defensible - prioritising real risk over paperwork and performative controls.
We help you meet regulatory and compliance expectations with confidence, producing work that stands up to scrutiny from partners, buyers, and regulators.
Everything you need to know about your obligations and next steps, in 20 minutes
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.
Yes, if your healthtech product is intended for use within the NHS or or publicly funded adult social care. Much like a Data Protection Officer (DPO), your organisation must have a named Clinical Safety Officer (CSO) responsible for overseeing clinical safety activities, including product updates and incident management. This is required to meet NHS clinical safety standards under Section 250 of the Health and Social Care Act 2012. The role can be outsourced if needed.
Any digital system used in publicly funded health or adult social care that could influence patient care in real time or near real time falls within scope. This includes clinical systems, patient-facing tools, administrative systems, and supporting technologies where failure or misuse could impact care delivery.
You can use our free CQC Readiness tool at assess.curistica.com to view example digital health categories and products to help build your DHT registry.
Yes. In England, under the Health and Social Care Act 2012, manufacturers of digital health systems are required to produce a DCB0129 clinical safety case. While enforcement has historically been variable, following DCB0129 is considered best practice across the UK and increasingly forms the foundation for NHS organisations to meet their own DCB0160 obligations.
Yes. DCB0129 is still required for digital health technologies used in NHS settings, even if ISO 14971 has been completed. The two standards are complementary but not interchangeable.
There is currently no single enforcement body. However, compliance is increasingly reviewed during procurement, audits, and CQC inspections, and expectations across the NHS are tightening.
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