NHS Compliance Tool

Answer 10 questions to understand which NHS clinical safety, cybersecurity and medical device requirements and regulations apply to your product.

Is your product a type of software (including AI; Software packaged with hardware etc)?

Will your product be used to support or deliver health or social care services?

Does your product affect access to or perform an action on clinical data (e.g. analysing, calculating, interpreting, predicting, recommending or altering)?

Could a misconfiguration, incorrect output, unexpected behaviour, loss of availability or cyber-attack of your product cause or contribute to patient harm?

Is your product intended to diagnose, prevent, monitor, predict, prognose, treat or alleviate disease or injury, or otherwise provide information for a medical purpose?

Does your product provide information that drives or influences diagnosis or treatment decisions where an incorrect output could cause serious deterioration, invasive interventions or death?

Is your product intended to monitor physiological processes or parameters where variations could result in immediate danger to the patient?

Does your product use artificial intelligence/machine learning to generate or influence clinical predictions, recommendations, classifications or decisions?

Does your organisation have 50 or more employees globally?

Does your organisation have £10m or more in global revenue per year?

Important: DSPT submissions apply to all businesses that process patient data or whose products interact with NHS systems.

This assessment provides an indicative screening result based on the information you have provided. It does not constitute legal, regulatory or clinical safety advice, certification, or a formal determination of compliance. Regulatory requirements depend on the specific product, intended purpose, deployment and organisational context. Where further assessment is recommended, or where you are uncertain about your obligations, contact our experts.

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NHS Compliance Tool

Before you start

Talk to the specialists behind NHS clinical safety and cyber assurance.