Behind on DCB0160 or DPIA?
We’ll get you CQC-ready — fast.
Trusted by visionary providers
to implement transformative tech
Clinical AI is improving care…and amplifying risk
DCB0160 and DPIAs are legal NHS requirements for every technology used in care.
They protect patients and reduce risk of harm, which increases as tools become more powerful.
Gaps can lead to CQC downgrades, penalties and serious safety issues.
As AI accelerates, so do your obligations. We help you meet them fast.
Our Services
We deliver confidence, not just compliance
Clinical Safety
Complete DCB0160 for safe and compliant deployment of a single technology, required for all DHTs used for care in the NHS.
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Audit of current clinical safety processes and documents with gap analysis for a single digital health technology
Hazard workshops with your cross functional team
Core document creation - Clinical Risk Management System (CRMS), Clinical Risk Management Plan (CRMP), Hazard Log, Incident Management Log, Clinical Safety Case Report (CSCR)
Clinical Authority to Release (CATR) certificate
Applicable for new product rollouts or non-compliant legacy products.
Data Protection
DPIA review for deployment of a single technology, required to meet UK GDPR, Data Protection Act and DSPT requirements.
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Assessment of your compliance needs against UK GDPR, the Data Protection Act and the Data Security and Protection Toolkit (DSPT)
Data Protection Impact Assessment (DPIA) and Privacy Policy review with recommendations and suggested changes
Meeting with your Data Protection Officer (DPO)/Caldicott Guardian to handover and answer questions
Done alongside clinical safety, we can save you time and money and mitigate gaps.
CQC-Readiness
Assessment and remediation of DHT governance gaps and implementation of a CQC-ready compliance system that protects your practice and secures your rating.
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Audit of all DHT risk and governance gaps for all technologies in your organisation, covering clinical safety, data protection, cybersecurity, and regulatory status issues
CQC Readiness Report and prioritised action plan
Complete DCB0160 Clinical Safety Case Report (CSCR) & Hazard Log for clinical safety gaps
Data Protection Impact Assessment (DPIA) review for data protection gaps
Connection with trusted partners for cybersecurity gaps
Embedded DHT governance processes into your existing frameworks and creation of a verifiable CQC Digital Assurance Pack
Ongoing CSO and DPO support
Keep your organisation DCB and GDPR compliant through incidents and product updates with our named CSO/DPO services or support
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Named and accountable Clinical Safety Officer (CSO) or Data Protection Officer (DPO) OR support for your in-house team
Incident Reviews and maintenance of DCB0160s through product updates
Annual review meetings
Integrated governance support and CQC ready documentation
Fills expertise or bandwidth gaps in your team, on demand, supporting a single or multiple technologies used in your organisation.
AI Education & Training
Workshops and talks on clinical AI, plus product-specific training to ensure frontline teams use new technologies safely and confidently.
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Lunch and learns and half-day workshops on clinical AI, delivered by experts in clinical, product and technology who speak your language. For your clinical, administrative or leadership teams.
We also offer product-specific frontline training to ensure your teams understand how to use newly implemented tools safely and confidently and meet your compliance requirements.
Our Clients
We partner with NHS providers leveraging technology safely to improve care
GPs, PCNs & Federations
Primary care is stretched. We bring frontline and technical expertise to help you adopt digital tools safely, meet CQC expectations and run practical, lightweight governance — without burdening your workload.
NHS Trusts
Trusts face a flood of new technologies and limited compliance capacity. We enable safe, efficient pilots and deployments with cutting-edge technical insight and robust clinical and data governance.
NHS ICBs
ICBs need system-wide compliance without system-wide cost. We coordinate governance across sites, share best practices, and liase with manufacturers so safe digital adoption becomes scalable and affordable.
Our team is unmatched in clinical safety and data protection for digital health and AI.
Decades of experience across frontline care, healthcare delivery, technology, and governance.
Practical, context-aware judgement: we understand how technology is really used in clinical settings and right-size mitigations to fit your environment.
Shaping the future of clinical AI: we’re actively contributing to national frameworks with the Department for Business and Trade, the CQC, and Radiant Cersi.
