DCB0129 Clinical Safety Case
Clinical Risk Management for NeuroPathway Health IT System
Total Hazards
8
Controlled
8
High Risk
0
Avg Residual Risk
4.9
Organisation Details
Organisation: NeuroPathway Ltd
Product: NeuroPathway Eco-System
Version: 2.1.0
Classification: Class I Medical Device (MHRA)
Website: neuropathwaysafespace.org
Clinical Context
Clinical Domain: Neurodevelopmental pathway management
Users: Children (8-17), Adults, Parents, Professionals
Settings: Schools, NHS Trusts, Social Care, Home
Primary Use: EHCP evidence collection, screening support
Scope of Clinical Safety Case
In Scope
- • Validated screening questionnaire delivery
- • AI-assisted EHCP evidence compilation
- • Mood and wellbeing tracking
- • Medication reminder functionality
- • Safeguarding alert detection
- • Professional dashboard and reporting
- • Multi-agency communication
Out of Scope / Limitations
- • Does NOT provide clinical diagnosis
- • Does NOT replace professional assessment
- • Does NOT provide crisis intervention
- • Does NOT prescribe or manage medication
- • Does NOT make referral decisions
- • AI outputs require professional validation
Clinical Risk Management Process
Hazard Identification
Systematic identification of potential clinical hazards
Risk Estimation
Assessment of severity and likelihood
Risk Evaluation
Determine acceptability using risk matrix
Risk Control
Implement mitigation measures
Monitoring
Ongoing review and incident tracking
I confirm that this Clinical Safety Case has been produced in accordance with DCB0129 and represents an accurate assessment of the clinical risks associated with the NeuroPathway system. All identified hazards have been assessed and appropriate controls implemented to reduce residual risks to acceptable levels.
Dr. Sarah Mitchell
Clinical Safety Officer
MBBS, MSc Clinical Informatics
Signed: December 22, 2024
Next Review: March 22, 2025