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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.
As Silvia prepares for its first NHS pilot deployment, formal governance processes are being developed with external support.
Clinical Use
Supporting safe clinical use
Silvia Lite 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.
Governance
Clinical governance approach
Silvia is being developed with reference to recognised digital health safety practices used within the NHS.
Governance work underway for NHS pilot deployment
Clinical risk management documentation
External Clinical Safety Officer (contracted through the Digital Health Assurance Company)
Data protection impact assessment preparation
Governance documentation supporting NHS digital deployment
This work supports Silvia's first NHS pilot partnership and is designed to embed governance processes early in the platform's development.
Progress
Assurance progress
ICO Registration
Silvia Health Ltd is registered with the Information Commissioner’s Office as a data controller.
Data Protection Impact Assessment (DPIA)
Assessment of patient data processing risks for pilot deployment.
Clinical Safety Documentation
Clinical risk management documentation is being 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 to support NHS pilot preparation.
NHS Digital Assurance Preparation
Preparation of documentation aligned with NHS digital assurance requirements.
ICO Registration
Silvia Health Ltd is registered with the Information Commissioner’s Office as a data controller.
Data Protection Impact Assessment (DPIA)
Assessment of patient data processing risks for pilot deployment.
Clinical Safety Documentation
Clinical risk management documentation is being 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 to support NHS pilot preparation.
NHS Digital Assurance Preparation
Preparation of documentation aligned with NHS digital assurance requirements.
NHS Pilot
Preparing for NHS pilot deployment
Silvia is preparing for its first NHS pilot deployment in partnership with a GP practice in England.
The pilot will support evaluation of structured menopause consultation preparation in primary care.
Governance work for this deployment includes clinical safety documentation, data protection processes, and external digital health governance support.
Regulatory Pathway
Regulatory development pathway
Silvia Lite currently operates as a structured digital intake platform that captures and organises patient-reported information for clinician review.
The platform does not diagnose, prescribe, or automate clinical decisions. Silvia Health does not consider Silvia Lite to meet the definition of a medical device under current UK regulations.
As Silvia evolves, Silvia Health is evaluating a future regulatory pathway aligned with UK medical device frameworks.
Silvia Lite
Structured menopause assessment platform capturing patient-reported information prior to consultation. Clinical decisions remain entirely with the clinician.
Software as a Medical Device - Class I
Future platform development may introduce regulated functionality requiring medical device classification under Class I medical software frameworks.
Software as a Medical Device - Class IIa
As Silvia expands clinical capabilities and evidence generation, regulatory pathways aligned with Class IIa software medical devices may be evaluated.
Our Commitment
Building safe digital health tools
Silvia is committed to developing responsible digital tools that support clinicians and improve menopause care.
Governance processes are being built into the platform from the early stages of development to support both private healthcare providers and future NHS deployment.
Regulatory notice
Silvia Lite is a structured intake tool that does not diagnose, prescribe, or automate clinical decisions. Silvia Health does not consider Silvia Lite to meet the definition of a medical device under current UK regulations. Silvia Pro is in development and is not commercially available.