Searches for “healthcare software development UK” and “NHS app development” keep rising alongside the wave of NHS AI and digital rollouts we have tracked this year. Buyers arrive with a product idea and leave a first supplier meeting holding a list of acronyms. This is the plain-English version, so you can ask better questions. It is a guide, not legal or clinical advice, and the NHS publishes the current detail for each standard.
The checks that come up most
- DCB0129 and DCB0160 (clinical safety). These are the NHS clinical risk management standards. DCB0129 applies to the organisation that makes health software; DCB0160 applies to the NHS body or provider that deploys it. In practice you need a named clinical safety officer, a hazard log and a safety case.
- DTAC (Digital Technology Assessment Criteria). The common NHS questionnaire covering clinical safety, data protection, technical security, interoperability and usability. Many NHS buyers ask for it before they will talk.
- DSPT (Data Security and Protection Toolkit). An annual self-assessment for organisations that handle NHS patient data.
- Medical device regulation. Software that diagnoses, monitors or recommends treatment may count as a medical device and need UK regulatory approval. A booking or messaging app usually does not. Work out which you are early, because it changes timeline and cost.
- Data protection. UK GDPR applies throughout, and health data is special category data.
Why it matters for cost
These requirements are cheapest when built in from the first sprint: audit logs, role-based access, hosting location and documentation. Retrofitting them to a finished prototype, including one produced quickly with AI tools, is where budgets slip.
So what
Before you pick a supplier, ask who will act as clinical safety officer, whether they have completed a DTAC, and how they handle patient data in testing. Our healthcare software development team builds with these in mind from day one. If you are scoping an NHS or clinical product, start a project and we will tell you honestly which checks apply.