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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.
Silvia is preparing for registration as a Class I medical device with the MHRA. This is a step we're taking voluntarily, ahead of any requirement to do so, because clinicians and patients deserve that level of scrutiny and trust.
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.
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. Work underway.
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.
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 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 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.
Silvia is preparing for registration as a Class I medical device with the MHRA. This is a voluntary commitment. Silvia Health is choosing the additional rigour, documentation, and external scrutiny that comes with formal medical device classification, because we believe that's what clinicians and patients should be able to expect from a platform used in clinical care.
Class I medical device, in preparation
Silvia is preparing for registration as a Class I medical device with the MHRA. The platform structures and organises patient-reported information for clinician review. The clinician retains full clinical decision-making at every stage. This reflects what Silvia is built to do, support the consultation, not replace clinical judgement.
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 NHS deployment.
Regulatory notice
Silvia is designed to support clinical judgement, not replace it. It captures and organises patient-reported information across 18 clinical domains for clinician review. It does not diagnose, prescribe, or automate clinical decisions. Silvia is preparing for registration as a Class I medical device with the MHRA. This is a voluntary step taken to support trust and transparency in clinical use. For more information, see our regulatory status page.