Digital clinical safety involves preventing harm to patients and staff arising from manufacturing, implementing and utilising technologies within healthcare. It includes the management of digital clinical risks, which necessitates a rigorous, systematic and well-documented process to assess and, if necessary, appropriately mitigate any clinical risks. This rigour is essential not only for compliance with established standards but also to ensure the safety of products for patients.
The Digital Clinical Safety Assurance team is crucial in providing clinical safety assurance services for in-house developed digital products and external customer offerings. Our primary objective is to ensure the safety of health IT and compliance with NHS clinical risk management and medical device standards.
The role of the Clinical Safety Officer (CSO) is to provide assurance in the development, deployment and modification of a Health IT System that is directly related to patient care (in scope). This includes the understanding of all clinical functionality, operational use and potential misuse to cause harm to patients. In essence, to do no harm.
We follow the following standards:
• DCB 0129: the clinical risk management standard which manufacturers of health IT systems and apps need to comply with. The standard is governed by NHS England and compliance is mandatory under the Health and Social care Act 2012.
• DCB 0160: the clinical risk management standard with which the deployment of health IT systems and apps need to comply. The standard is governed by NHS England and compliance is mandatory under the Health and Social care Act 2012.
• Medicines and Healthcare Products Regulatory Agency (MHRA): if an item of software or spreadsheet that you develop or use is a medical device and comes under the Medical Device Regulations (MDR), we would identify and classify any software medical devices.
Our offer
- Patient and clinician safety in clinical digital systems
- Software medical device recognition and definition
- Implementation of correct Digital Clinical Standards
- Completion of bespoke deliverable documentation (DCB0129 / DCB0160)
- Teaching – any aspect of Clinical Digital Assurance (apart from MDR).
The benefits
- Our service goal is to strive for patient and clinical safety in health IT.
- Knowledgeable and experienced Clinical Safety Officers in both the manufacturer and deployment processes.
- NECS is an NHS organisation.
- Proven record of accomplishment and governance framework.
Case studies
Clinical safety assessment of the Professional Records Standards Body new diabetic standards
The Professional Records Standards Body (PRSB) was commissioned by NHS England to produce standards for sharing diabetes information across all care settings safely and accurately between digital systems, with no loss of meaning to support safe, high-quality care. This also includes the self-management data from digital applications and medical devices such as glucose monitors.
Clinical safety assessment of the HealthPathways Health IT system
HealthPathways, a Health IT system developed by Streamliners in New Zealand, supports the delivery of localised relevant pathways to general practitioners and other clinicians. The system assists with informed and supportive decision making at the point of care, within any locally agreed health policies.
Contact the team
Andy Rooks
Principal Clinical Safety Officer
Deborah Giles
Senior Strategic Lead Pharmacist – Medicines Optimisation and Digital Clinical Safety Assurance