Clinical Governance
MoleScan is built on a foundation of clinical safety, data protection, and quality assurance. Every assessment is reviewed by UK GMC-registered clinicians with specialist expertise in dermatology (GPwSI), supported by structured processes and robust clinical governance.
DCB0129 Aligned
Clinical safety framework for digital health systems
GDPR Compliant
ICO registered with UK data residency and encryption at rest and in transit
CQC Registered
Care Quality Commission regulated service
GMC-Registered Doctors
All doctors hold current GMC registration and relevant clinical experience
Clinical Safety
DCB0129 & DCB0160
MoleScan's clinical safety framework is aligned with DCB0129 (manufacturer responsibility) and DCB0160 (deploying organisation responsibility). A formal Clinical Safety Case is maintained and regularly reviewed.
Clinical Safety Officer
MoleScan maintains a designated Clinical Safety Officer (CSO) responsible for the Clinical Safety Case, hazard management, and incident reporting in line with NHS digital safety standards.
GPwSI Dermatology Doctor Review
Every assessment is reviewed by a UK GP with specialist expertise in dermatology (GPwSI). No clinical output is delivered without qualified clinician oversight. This human review is central to MoleScan's safety model.
Data Protection & Privacy
GDPR Compliance
MoleScan complies with the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018. Dermme Health Ltd is registered with the Information Commissioner's Office (ICO).
UK Data Residency
All patient data is stored within the United Kingdom, with no routine transfer outside the UK.
Encryption
All data is encrypted in transit (TLS 1.2+) and at rest (AES-256). Access to patient data is strictly controlled through role-based access controls, ensuring only authorised users can access sensitive information.
Data Minimisation
MoleScan collects only the minimum data required for clinical assessment. Data retention policies are clearly defined, documented, and auditable.
Quality Assurance
Structured Reporting
Every MoleScan report follows a standardised clinical format, ensuring consistency, clarity, and completeness across all assessments.
Audit Trail
A complete audit trail is maintained for every assessment, including image capture, clinical review, and report delivery timestamps.
Continuous Improvement
MoleScan monitors clinical outcomes and assessment quality through regular audit cycles, with findings feeding directly into ongoing platform and process improvements.
Accessibility & Standards
WCAG 2.2 AA Compliance
The MoleScan platform and website are built in line with WCAG 2.2 Level AA accessibility standards.
NHS Service Standard Alignment
MoleScan is designed with reference to the NHS Service Standard, supporting usability, accessibility, and clinical safety requirements.
Frequently Asked Questions
MoleScan is a clinical workflow and triage platform that supports practitioner decision-making. It is not currently classified or registered as a standalone medical device. The platform provides structured clinical triage with review by UK GPs with specialist expertise in dermatology (GPwSI). The final clinical decision always rests with the treating practitioner.
MoleScan maintains a clinical incident reporting and management process aligned with DCB0129. All incidents are reviewed by the Clinical Safety Officer, with findings incorporated into the Clinical Safety Case and hazard log. Serious incidents are managed and escalated in line with regulatory requirements.
A summary of MoleScan's Clinical Safety Case is available on request. Please contact us or request a demo to discuss clinical governance documentation.
All MoleScan doctors are registered with the General Medical Council (GMC). All doctors hold appropriate training and experience in dermatology and skin lesion assessments (GPwSI or equivalent), and all clinicians undergo credential verification before joining the platform. Ongoing professional registration and compliance are regularly reviewed.
Want to Know More About Our Governance?
Request a demo to explore MoleScan's clinical safety framework, data governance model, and compliance standards — including our Clinical Safety Case and structured assessment pathway.