What is classed as a service, care pathway, or non-technology innovation?
Service, care pathway, and non-technology innovations focus on the delivery and organisation of care that does not require a medical device or technology. They focus on changing staff workflow, human behaviour, and structural processes to enhance efficiency, staff and patient experiences, and patient outcomes.
What regulatory approvals do services, care pathways, or non-technology innovations require?
Services, care pathways, or non-technology innovations typically require the following in order to be implemented into the NHS:
Clinical safety standards
The NHS requires DCB0129 (clinical risk management for manufacturers) and DCB0160 (clinical risk management for health organisations) to identify and control risks of harm. DCB0129 requires a clinical safety officer, a clinical risk management file, a hazard log, a clinical safety case report, and post-market clinical safety processes. DCB0160 requires the adopter to review the manufacturer’s DCB0129 documentation, conduct a local clinical risk assessment, a local hazard log, a local clinical safety case report, and ongoing governance once live. This assesses whether the innovation is safe in the local environment that it is going to be adopted within.
Alignment with NICE guidance
Innovations must reflect best practice and evidence-based care as depicted within guidance from NICE. Guidance around treating and managing different conditions or diseases is available.
Data protection compliance
Innovations must comply with data protection laws in the UK. For more information on data protection compliance, check out the guidance here.
Net zero requirements
Innovations must align with delivering a net zero NHS by 2040. As well as this, innovations must adhere to carbon reporting expectations. A full Carbon Reduction Plan is required for procurements of over £5 million per annum including VAT, or a Net Zero Commitment for procurements lower than £5 million per annum including VAT.
Overall, understanding the requirements for services, care pathways, and non-technology innovations is essential to ensure they can be safely and effectively implemented within the NHS. While these innovations do not require device-specific regulation, they must still meet key standards around clinical safety, evidence-based practice, and data protection. Ensuring alignment with NICE guidance and NHS risk management processes is critical to supporting adoption and delivering high-quality patient care.