Insights
Clinical safety and NHS assurance, explained
Insights briefings are produced automatically, once a week, from a fixed list of official UK sources. Every factual claim is tied to a primary source that was fetched and checked during the run, and each briefing says plainly what kind of thing it is describing — law, standard, guidance, consultation or judgment.
Briefings published before the approval process began were produced automatically and were not reviewed by a person before publication. New briefings are published only after a named person approves them. They are general information, not advice, and they carry no clinical or legal review. Our guides and downloadable resources are different: those are reviewed and approved by a person before publication.
Latest briefings
- Guidance30 October 2026both
Healthcare AI clinical safety assurance guide
A practical assurance pathway for healthcare AI: intended use, patient hazards, human oversight, monitoring and NHS deployment duties.
- Guidance30 October 2026both
How an NHS DTAC assessment works
Follow a DTAC assessment from supplier evidence to the NHS buyer's decision, including trials, specialist review and reassessment.
- Guidance30 October 2026both
Clinical hazard log example: worked entry
See an illustrative health IT hazard log entry and learn how to record causes, patient harm, controls, evidence and residual risk.
- Guidance30 October 2026both
Clinical Safety Officer requirements and training
What should an NHS-facing health IT team look for in a Clinical Safety Officer? Understand competence, authority and the training question.
- Guidance30 October 2026both
DCB0129 vs DCB0160: who is responsible for what?
Compare manufacturer DCB0129 and deploying-organisation DCB0160 duties, with a practical handover example.
- Guidance30 October 2026both
DCB0129 requirements for health IT suppliers
Understand the DCB0129 clinical risk management process, CSO role and evidence a health IT manufacturer should maintain.
- Guidance30 October 2026both
Is DTAC a certification? What suppliers can claim
DTAC is an NHS assessment framework. Learn who assesses a product, what third-party certificates mean and what suppliers should claim.
- Guidance30 October 2026both
How to complete the NHS DTAC form
A practical sequence for completing the current NHS DTAC form, assigning evidence owners and avoiding version or document gaps.
- Guidance30 October 2026both
NHS DTAC requirements: evidence checklist
Understand the five NHS DTAC assessment areas and prepare a product-specific evidence pack before a buyer requests it.
- Guidance30 October 2026both
Clinical safety case report: worked example
See how a clinical safety case report connects intended use, hazards, controls and evidence, with an illustrative example for health IT teams.
- Guidance26 October 2026supplier
Changing AI medical devices: keeping assurance current
Changing an AI medical device calls for a clear connection between the change, its supporting evidence and its behaviour in use. This standing explainer distinguishes what the supplied MHRA pages establish from practical assurance controls suppliers can consider.
- Guidance19 September 2026both
AI scribes: safety questions to settle before clinical use
Before introducing an AI scribe, settle what it is intended to do, how its output will be checked and what happens to the information it captures. These questions connect product claims, local clinical safety and data protection.
Spotted an error in a briefing, or want something covered? Email enquiries@assuranceai.co.uk.