Supporting digital innovation with vigilance

We are a team of clinical professionals delivering clinical safety, clinical assurance and risk management for digital health projects.

Clinical Assurance

Consultancy

Practical clinical safety and governance advice to support safe, effective clinical digital products and services.

Digital Clinical Safety Assurance

Support for DCB0129 compliance, including clinical risk management, safety case development and Clinical Safety Officer assurance for digital health products.

Digital Clinical Risk Management

Support for DCB0160 compliance, ensuring clinical risks are identified, controlled and monitored during digital system deployment and use.

Clinical Governance

Design, support and ongoing monitoring of robust clinical governance systems that stand up to real‑world use.

Independent clinical professionals

We are independent and trusted clinical professionals, who are innovation friendly and aligned with NHS standards.

Clinical Safety Experts

Providing expert health solutions to support assurance of clinical projects.

Clinical Safety Assurance

Expert health solutions to support assurance of clinical projects.

Consultancy & Advice

Robust expert advice on clinical digital projects and governance

Risk Management

DCB0126 / DBC0160 risk and hazard management

Training & Capacity Building

Bespoke training to increase capacity to support clinical services

Clinical Governance

Clinical governance solutions to support clinical safety

innovation Friendly

Supporting innovation and service building

Vigilance for clinical innovation in healthcare

Mission

To support the NHS in delivering safe, effective digital healthcare, through expert consultancy, risk management, and robust clinical safety assurance.

Sentinel Clinical Assurance offer a range of services to support clinical risk management and clinical safety assurance.

Vision

To be the trusted guardian of clinical safety in digital healthcare, enhancing innovation while safeguarding patients and clinicians alike.

Clinical Assurance for a Range of Clinical Services and Projects

Electronic Patient Care Record (ePCR)

An independent ambulance provider delivering emergency and event medical services required implementation of an electronic patient care record (ePCR). A structured implementation approach was applied to establish clear operational processes, defined lines of clinical accountability, and safe integration of clinical and digital systems supporting service delivery.

Result
Risk Reduction
Hazards proactively managed
Clear Accountability

Defined clinical ownership

Assured Delivery

Consistently safe services

User Confidence

Training and Support

Safer Practice

Clear record keeping

Auditable

Standardised record keeping

Assurance
Support
Confidence

Ambient Scribe for Commanders

An independent ambulance provider deployed an ambient clinical scribe solution to reduce documentation burden for commanders. Clinical governance and digital safety assurance are embedded from the outset to manage risks related to accuracy, data security, clinician oversight, and patient safety.

Result
Reduced Burden

Less commander documentation

Improved Accuracy

Clear command records

Commander Trust

Confidence in outputs

Safe Deployment

Controlled risk introduction

Workflow Efficiency

More command focus

Information Governance

Secure data handling

Trust
Accuracy
Protection

Clinical Governance

An independent ambulance provider delivering emergency and non‑emergency services on behalf of event companies and private commissioners. A structured clinical governance and assurance framework was implemented to ensure safe practice, effective oversight of digital systems, and compliance with commissioned service requirements.

Result
Risk Reduction
Hazards proactively managed
Clear Accountability

Defined clinical ownership

Assured Delivery

Consistently safe services

Commissioner Confidence

Evidenced service assurance

Safer Practice

Reduced clinical variation

Regulatory Readiness

Inspection‑ready governance

Assurance
Safety
Confidence

Frequently Asked Questions

Clinical safety assurance ensures that digital health systems are safe to use and do not introduce unacceptable risk to patients or clinicians. In the NHS, this is mandated through DCB0129 and DCB0160, which require structured identification, assessment, and management of clinical risks across the system lifecycle.

We provide proportionate, end‑to‑end support for DCB0129 (manufacturers) and DCB0160 (deploying organisations), including Clinical Safety Officer support, safety case development, hazard logging, risk management, and independent assurance reviews aligned to national expectations.

We work with both NHS organisations and digital health suppliers, supporting safe design, deployment, and use of clinical digital systems. We also support joint NHS–supplier programmes to ensure alignment and shared understanding of clinical risk.

We help embed digital clinical safety within existing clinical governance frameworks, ensuring clear accountability, effective escalation, and robust oversight. This supports sustainable assurance rather than one‑off compliance activity.

We apply a lifecycle‑based approach to clinical risk management, from early design and procurement through implementation, change, and live operation. Our focus is on proactive risk identification, control, and assurance to support safe patient care and organisational confidence.