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Governance
Clinical Safety & Governance
Silvia is designed to support safe menopause consultations by organising structured patient-reported information for clinician review.
Patient safety, data protection, and responsible digital health governance are priorities that inform the platform's development from the outset.
Clinical Use
Supporting safe clinical use
Silvia supports menopause consultations by organising patient-reported information into a structured format for clinician review before the consultation begins.
Patients complete a structured assessment prior to their appointment, allowing clinicians to review relevant symptoms, history and health domains in advance.
The platform helps clinicians by
Organising patient-reported symptoms and experiences
Capturing structured information across menopause health domains
Presenting patient context prior to consultation
Supporting efficient and consistent consultation preparation
Silvia does not diagnose, prescribe, or automate clinical decisions.
All clinical decisions remain with the healthcare professional.
Data Protection
Data protection and privacy
Protecting patient information is central to Silvia's platform design.
Silvia Health Ltd is registered with the Information Commissioner's Office (ICO) as a data controller.
Encrypted data transmission
Patient data is encrypted in transit to protect information during transfer.
Data storage practices
Patient information is hosted on infrastructure with access controls and encryption at rest.
Role-based clinician access
Clinician access is managed through role-based permissions.
GDPR-aligned processes
Data protection processes are aligned with GDPR requirements.
These measures support the responsible handling of patient information.
Progress
Assurance progress
ICO Registration
Silvia Health Ltd is registered with the Information Commissioner’s Office as a data controller.
Penetration Testing
Silvia has undergone independent penetration testing to assess platform security.
Cyber Essentials Certified
Silvia Health holds Cyber Essentials certification, demonstrating baseline cyber security controls.
Data Protection Impact Assessment (DPIA)
Assessment of patient data processing risks completed ahead of pilot deployment.
Clinical Safety Documentation
Clinical risk management documentation developed with support from an external Clinical Safety Officer.
Clinical Safety Officer Review
Silvia Health has contracted an external Clinical Safety Officer through the Digital Health Assurance Company.
DTAC
Digital Technology Assessment Criteria assessment complete, demonstrating alignment with NHS digital health standards.
DSPT
Data Security and Protection Toolkit submission in progress ahead of NHS deployment.
Regulatory Commitment
Our regulatory commitment
Silvia structures and organises patient-reported information for clinician review. It does not diagnose, prescribe, or automate clinical decisions. Every clinical decision remains with the healthcare professional.
Our Commitment
Building safe digital health tools
Silvia is committed to developing responsible digital tools that support clinicians and improve menopause care.
Governance processes have been built into the platform from the early stages of development to support both private healthcare providers and NHS deployment.
Regulatory notice
Silvia is designed to support clinical judgement, not replace it. It organises patient-reported information across 70+ clinical considerations for clinician review. It does not diagnose, prescribe or automate clinical decisions. Based on its intended purpose, Silvia does not meet the definition of a medical device under current UK regulations. For more information, see our regulatory status page.