Regulatory Approvals & Certifications

Medical Device Compliance

NeuroPathway is registered as a Class I Medical Device for digital health monitoring and assessment support, complying with UK MDR 2002 and EU MDR 2017/745 regulations.

Clinical Safety Standards

Meets DCB0129 and DCB0160 clinical risk management standards for health IT systems, with regular clinical safety assessments and hazard logs maintained by qualified Clinical Safety Officers.

Post-Market Surveillance

Active vigilance system monitoring adverse events, near misses, and safety incidents with mandatory reporting to MHRA within required timeframes.

DCB0129: Clinical Risk Management

Full compliance with DCB0129 standards for clinical risk management, ensuring systematic identification, assessment, and mitigation of potential clinical hazards throughout the system lifecycle.

• •Qualified Clinical Safety Officer appointed with documented responsibilities
• •Clinical Safety Case Report maintained and regularly updated
• •Hazard log actively monitored with risk scores and mitigation strategies
• •Clinical risk assessments performed for all system changes

Clinical Safety Officer: Dr. Sarah Jane, MBBS, MSc Clinical Informatics

DCB0160: Clinical Safety Case Reports

Comprehensive Clinical Safety Case Reports produced for deployment into NHS environments, demonstrating evidence-based safety assurance and hazard mitigation strategies.

• •Pre-deployment safety case with hazard identification and risk analysis
• •Post-deployment monitoring and incident reporting procedures
• •Safety case updates for major system modifications
• •Integration with organizational clinical governance frameworks

Latest Safety Case: Version 2.1, January 2025 | Next Review: July 2025

DCB0211: Data Security and Protection

Adherence to DCB0211 requirements for securing NHS data, including strong standards, access controls, audit logging, and data protection impact assessments.

• •AES-256 encryption for data at rest and TLS 1.3 for data in transit
• •Role-based access controls with multi-factor authentication
• •Comprehensive audit trails with tamper-proof logging
• •Regular penetration testing and vulnerability assessments

HRA & REC Approval

Approved by the Health Research Authority (HRA) and Research Ethics Committee (REC) for studies involving neurodivergent children and vulnerable populations, with full ethical safeguards.

Reference: REC 24/NE/0123 | Approved: January 2024

NHS R&D Permissions

Local NHS Trust R&D approvals secured for pilot implementations in CAMHS services, schools liaison teams, and adult mental health services across multiple NHS Trusts.

Academic Partnership

Collaborative research agreements with leading UK universities studying early intervention outcomes, AI safety in healthcare, and neurodevelopmental assessment accuracy.

NHS Digital DSPT

Data Security and Protection Toolkit compliant, meeting all mandatory standards for processing NHS patient data including encryption, access controls, and staff training.

Status: Standards Met | Last Assessment: 2024/25

Cyber Essentials Plus

Certified Cyber Essentials Plus accreditation demonstrating robust cybersecurity controls against common internet-based threats, verified through independent technical assessment.

ISO 27001 Information Security

Internationally recognized information security management system (ISMS) certification with annual surveillance audits ensuring continuous compliance with security best practices.

UK GDPR & Data Protection Act 2018

Full compliance with UK data protection legislation including lawful basis documentation, privacy by design principles, data minimization, and subject access request procedures.

Working Together to Safeguard Children 2023

Platform designed and operated in accordance with statutory safeguarding guidance including mandatory reporting protocols, information sharing frameworks, and multi-agency working principles.

DBS-Checked Staff

All staff with access to children's data hold enhanced DBS checks with barred list checks, renewed every three years with continuous monitoring of safeguarding concerns.

Designated Safeguarding Lead

Qualified DSL available with direct escalation pathways, mandatory Level 3 safeguarding training, and established links with local authority safeguarding partnerships and MASH teams.