Ensure that the product is clinically safe to use Rationale All digital health technologies must be clinically safe to use. The development process for data-driven software for clinical purposes contains key differences to the development of software for general purposes. These should be well understood and factored into operations from discovery. The development of clinical products benefits from technical expertise sitting side by side with clinical expertise in the form of a Clinical Product Owner. This avoids the common pitfall of having to attempt to retrofit necessary clinical input on quality and safety too late in the development process. To sell into the NHS, manufacturers must demonstrate compliance with the Clinical Safety Standards referred to as DCB0129 and DCB0160. This is mandated under the Health and Social Care Act 2012. DCB0129 requires manufacturers to:
have a clinical safety management system - a defined process by which clinical safety is considered during design, pre-release and in response to any information about incidents
carry out specific clinical risk management activities, usually in the form of a ‘hazard workshop’ - a systematic approach to the identification of risk and mitigating actions
to maintain the following related clinical safety documentation:
a hazard log for the product - effectively a clinical risk register for the product. It is a live document and should be kept up to date in the light of product changes or clinical incidents
a clinical safety case report. Prior to release, the safety case report should summarise hazards, their mitigation and the justification for release. This is a companion document to the hazard log
a clinical safety management plan - the document that describes how the clinical risk management system will apply to a particular product over the product life cycle
Evidence for hazard control often comes from the technical testing carried out on the product prior to release. Suppliers should give a copy of their DCB0129 hazard log and clinical safety case report to customers so they can carry out their duty of compliance with DCB0160, the companion standard. The customer will carry out a similar structured risk assessment considering the product in the circumstances of their own specific deployment. It is a requirement that all documents are approved by a Clinical Safety Officer (CSO). A CSO is a clinically-qualified individual who has undergone appropriate specific training with NHS Digital. This person should ideally be involved in the clinical risk management activities and verify that appropriate processes have been followed. If the product requires clinicians to operate it, organisations must supply details of clinicians involved and their relevant professional registration. In addition, evidence must be shown of origin and provenance of clinical reference sources.